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Phase 4 clinical trials look at drugs that have already been approved by the FDA. Even though a drug may be prescribed to patients, this type of clinical trial is still important for answering questions. Phase 4 clinical trials usually involve thousands of people. It is usually the safest type of clinical trial because the medication has already been approved. These studies will usually look at other aspects of the treatment process, including how cost-effective it is. This type of study may also be conducted to evaluate whether the medication is having an impact on someone's overall quality of life.

Phase IV (Clinical Trial)

A heroic dose is a colloquial term used to describe the administration of a very large quantity of a hallucinogenic substance. When this dose is administered, it leads to a very powerful effect, which some people describe as life-changing. Even though taking a larger dose can lead to a more powerful impact, it can also increase the chances of someone suffering serious complications and side effects, depending on the exact type of hallucinogenic substance they are taking. People who ingest a heroic dose often describe more powerful visual hallucinations, auditory sensations, and changes in perception. Many individuals who take a heroic dose have a sitter present with them who can intervene if they start to experience negative side effects.

Heroic Dose

During a clinical trial, participants need to be blinded, meaning they should not know whether they are receiving the control treatment or the experimental treatment. An active placebo is designed to be a more powerful control, tricking someone into thinking they are receiving the psychoactive drug that is being investigated. For example, if the experimental group is receiving a psychedelic drug, the control group might receive Niacin, which is a B vitamin that produces a physical reaction. Individuals who take Niacin in large amounts often turn red and become flushed, which could cause someone to believe they received the experimental medication. If participants can figure out if they are receiving the experimental drug or the control drug, it could compromise the blinding of the trial and damage the integrity of the results. An active placebo is designed to prevent this from happening.

Active Placebo

Afterglow is usually used to refer to the positive mental and physical effects that someone experiences after the original effects of a drug have subsided. Typically, this term is used in association with hallucinogens, including psychedelics. Individuals typically have more energy and feelings of freedom during an afterglow. Some of the most common experiences include an increased state of confidence, a feeling of relaxation, difficulty falling asleep, and a feeling of being clean. Not every drug causes an afterglow, but drugs that lead to an afterglow typically lead to these effects after the comedown phase. Individuals who experience an afterglow often describe a mystical or transcendental experience that cleanses them of negative energy and causes them to feel more alive.

Afterglow

An anxiolytic is any substance that helps someone treat or reduce their anxiety. Some of the most common anxiolytics include benzodiazepine medications including Xanax, Klonopin, Valium, and Dalmane. Different anxiolytic medications have different degrees of onset. For example, Xanax kicks in quickly and leaves the body quickly, while Klonopin takes a longer time to work but also lasts longer in the body. Not every anxiolytic is a drug, as there are other ways people can treat their anxiety. The opposite of an anxiolytic is an anxiogenic, which is anything that increases anxiety.

Anxiolytic

An agonist refers to any molecule that triggers the effects of a receptor. After an agonist binds to a receptor, the receptor should trigger its effects downstream. For example, if a drug binds to a G Protein-Coupled Receptor, then an agonist that binds to this GPCR should cause the GPCR to release its G Protein. A single receptor can have multiple agonists because there are multiple molecules with the same structure that could trigger its effects. In addition, some drugs may be considered to be a partial agonist, which means that it only triggers a portion of the receptor’s total activity. There are also some molecules that could be considered an inverse agonist, which means that they bind to the receptor and trigger the opposite effect when compared to a traditional agonist. Agonists include neurotransmitters that occur naturally in the brain as well as recreational or prescription substances that people administer themselves. Agonists can also be found in substances that occur naturally in nature.

Agonist

If something receives a breakthrough therapy designation, the designation is designed to expedite the approval process. Typically, this designation is given if there is preliminary clinical evidence that therapy being developed has the potential to significantly improve existing treatments or create a new category of effective treatment altogether. There are numerous examples of substances being given a breakthrough therapy designation over the years, with one example being the esketamine nasal spray Spravato. This treatment was found to be particularly effective at treating depression, so it was given a breakthrough therapy designation to fast-track it through the approval process. After being given a breakthrough therapy designation, the treatment can still be given full approval by the FDA down the road.

Breakthrough Therapy Designation

Bufotenin, which is sometimes spelled Bufotenine, is a derivative of tryptamine and is closely related to serotonin, a neurotransmitter. Bufotenin is an alkaloid that can be found in mushrooms and toads. The substance is structurally similar to DMT and 5-MEO-DMT. Research has shown that Bufotenin can have a variety of impacts on people, including visual hallucinations. The drug typically kicks in much faster than other psychedelic substances, such as LSD. Then, it leaves the system faster as well. This indicates that it has a much faster action time in the central nervous system.

Bufotenin (5-HO-DMT or bufotenine)

18-Methoxycoronadine is a derivative of ibogaine. The compound was invented in 1996 by a combination of researchers and chemists from the University of Vermont. 18-Methoxycoronaridine has been studied at length in clinical trials and has been found to reduce nicotine and alcohol intake in rats. The drug is being further studied for the potential treatment of alcohol and nicotine addiction in humans.

18-Methoxycoronaridine (18-MC)

Ayahuasca is a psychedelic drink or brew that is commonly used in South America that has spread all over the world. It is a common ceremonial spiritual medicine, particularly among cultures that have lived near the Amazon basin for centuries. It is made from a variety of ingredients, with the Banisteriopsis Caapi vine and the Psychotria Viridis shrub being some of the central ones. When put together, the MAOIs from the Baniesteriopsis activate the DMT in the Psychotria, leading to the psychedelic impact people feel. The substance plays a significant role in religious ceremonies, and it is often administered with the supervision of a shaman or a sitter who has experience watching these ceremonies unfold.

Ayahuasca

Cluster headaches are one of the three most common types of headaches (with the other two being tension headaches and migraine headaches), and they cause a wide variety of symptoms. Some of the most common symptoms of cluster headaches include paralysis, tearing, and sweating on one-half of the face only. Some people have cluster headaches regularly while other people may only have one cluster headache before dissipating. Many people who have cluster headaches experience cluster periods where they might experience multiple headaches quickly over a period of a week or a month. Then, the headaches might go into remission, where people do not experience a single headache for a year or more. The most common treatment option for cluster headaches is supplemental oxygen; however, there are other treatment options that are being explored as well, including LSD, psilocybin, and other psychedelic drugs.

Cluster Headaches

The Centre for Psychedelic Research, Imperial College London has spent more than a decade performing research on psychedelic drugs in the Imperial College in London. The center is led by Dr. Robin Carhart and focuses on psychedelics and their impacts on mental healthcare as well as how psychedelics can be used to explore the brain’s consciousness. The goal of the center is to develop a research clinic that can gather clinical evidence that may inspire the use of psychedelic drugs as a more widely accepted treatment option in the future.

Centre for Psychedelic Research, Imperial College London

The Center for Drug Evaluation and Research is a division of the FDA that is responsible for making sure that drugs administered to people in the United States are both safe and effective. The CDER covers a wide variety of substances including generic, prescription, and over-the-counter drugs. The CDER keeps an eye on drugs that are not only in the pipeline but also those that are already on the market. The CDER also encourages the research of treatment of orphan diseases, or those that might not receive the same level of attention of more common conditions. The CDER also regulates substances such as toothpaste and shampoos.

Center for Drug Evaluation and Research (CDER)

DMT is an analog of the tryptamine molecule. DMT occurs naturally in numerous plants and animals. It is commonly used as a recreational psychedelic drug, and it has a history of being used in rituals by indigenous cultures. DMT has a very quick onset and a relatively short action period. Typically, people feel the effects of DMT in minutes, and it usually fades by about three hours after ingestion. DMT is commonly used in the Ayahuasca brew, and it can be injected, inhaled, or ingested. Oral ingestion has the longest action time, while injection and inhalation have significantly shorter action times. People who take DMT often describe vivid experiences, mystical feelings, and hallucinations.

DMT (N,N - Dimethyltryptamine)

The Council on Spiritual Practices is an organization that seeks to bring together spiritual guides, scientists, and religious scholars who are interested in the importance of having direct experiences with a higher dimension. The goal is to have people of all backgrounds working together to pursue a common goal. People who are members of this group believe that experiences, facilitated by spiritual practices, can have significant impacts on the individual who was going through them. As a result, it has the potential to change the way people see the world. The council was developed in the 1990s, and it is responsible for pushing the Entheogen project, which are substances that are usually taken to facilitate such mystical experiences. The group has grown in power and influence during the past few decades.

Council on Spiritual Practices (CSP)

A Controlled Drugs and Substances Dealer’s License is a Canadian license granted by Health Canada under the provisions of the Controlled Drugs and Substances Act. This license allows the holder to procure, research, manufacture, and sell controlled substances. Individuals who do not have this license and attempt to procure or sell controlled substances can face significant fines and sanctions. There is a strict process people need to follow to apply for this license, and the license is closely supervised by the authorities.

Controlled Drugs and Substances Dealer’s License

Dextromethorphan is a common cough suppressant that is found in more than 120 cold medications that are sold over the counter. In some cases, dextromethorphan is sold alone. In other cases, it can be combined with a wide variety of other treatment options for the common cold including expectorants, decongestants, and antihistamines. Dextromethorphan is also commonly used as a recreational substance because it can cause visual and auditory hallucinations, causing people to feel a euphoric sensation. Some of the most common names for dextromethorphan recreational use include skittling, dexing, and robo-tripping. Dextromethorphan is sold as capsules, tablets, and cough syrup, but it can also be found as a powder over the internet.

DXM (Dextromethorphan)

Datura refers to a group of flowering plants that secrete a variety of substances, with some of them being poisonous. The plants belong to the nightshade family, and they are commonly called Devil's trumpets, Jimson's weed, Thornapple, Hell's Bells, Devil's weed, and Moonflower. Some of the substances can be psychoactive. Some compounds are hallucinogenic, with specific compounds playing a role in religious rituals traditionally practiced by Native American groups, particularly those that resided in the Desert Southwest. These religious ceremonies are typically supervised by a religious guide, such as a shaman. Poisonous compounds from this planet can lead to fever, delirium, cardiac arrhythmia, and respiratory depression. An overdose of the substances from these plants can be fatal.

Datura

A dissociative substance is a substance that changes people's perceptions of sight and sound, causing someone to feel like they are being detached from themselves. An anesthetic is a drug that is designed to cause a temporary loss of sensation, including pain. Dissociative anesthetics target the central nervous system to change sensory stimulation, causing someone's senses to be significantly altered. People who use dissociative anesthetics often describe communing with a higher power or changing the way they see the world. Some people describe having the ability to look down on their own body as they receive treatment. There are numerous drugs that fall into this category, and many of them have different mechanisms of action. Most of the compounds have relatively quick times to onset, and then they leave the body just as quickly.

Dissociative Anaesthetics

Dopamine is one of the most important neurotransmitters in the human body. It plays a critical role in the central nervous system, and it is responsible for regulating a wide variety of body processes. It is a member of the catecholamine and phenethylamine families. It is made from its precursor, L-DOPA, which is made in the kidneys and brain. Dopamine is released by neurons in the central nervous system and is used to transmit signals to other cells throughout the body. Dopamine is involved in the reward processes of the brain, meaning that it can play a role in addictive behavior. Many mental health treatments target dopamine receptors and production as well. Dopamine has also been closely linked to internal motivation. When dopamine is outside of the central nervous system, it functions as a local messenger, playing a role in the cardiovascular and gastrointestinal systems. Treatments involving dopamine are used to treat Parkinson's disease, nausea, restless leg syndrome, ADHD, and acute cardiovascular issues, including shock and heart failure.

Dopamine

Ecstasy, which is also known as MDMA or Molly, is a psychoactive drug that is used for recreational purposes. It can cause someone to feel an increased amount of energy and empathy as well as create euphoric experiences. If MDMA is taken by mouth, its effects usually begin within about 30 minutes. Then, they dissipate in three to six hours. This psychoactive drug was popular during the 1970s and 1980s, but it is experiencing a resurgence. A lot of people like to mix MDMA with methamphetamine and ephedrine. MDMA influences levels of serotonin, dopamine, and noradrenaline in the central nervous system to exert its effects. Individuals who take MDMA often describe seeing vivid colors, sounds blurring together, and objects having wavy lines or appearances. MDMA is a Schedule I controlled substance.

Ecstasy

Eleusinian Mysteries refers to certain rites of initiation that were held annually at the sanctuary of Eleusis, located in ancient Greece. The cult was founded on a myth related to the abduction of Persephone from her mother. A wide variety of similar cults and initiations appeared in similar areas, including Crete. The mysteries involved conjuring images and visions of the afterlife, and many of them involved psychedelic drugs.

Eleusinian Mysteries

The default mode network, usually shortened to DMN, is a network at the front of the brain that includes the angular gyrus, the posterior cingulate cortex, and the medial prefrontal cortex. This area of the brain is most active when someone is not focused on the outside world and is instead daydreaming, wandering, or resting in a wakeful state. The network can also be active when someone is thinking about something deep, reminiscing about certain memories, and making plans for the distant future. Problems involving this part of the brain are common in individuals who are diagnosed with autism spectrum disorder and Alzheimer's disease. The network has been studied extensively by research professionals who are looking for new treatment options for mental health issues.

Default Mode Network (DMN)

Digital Therapeutics is a growing area of digital health. It refers to a set of therapeutic interventions that are driven by high-quality software programs that can help manage, treat, or prevent a medical condition from developing. Digital therapeutic companies regularly publish evidence-based on trial results that show meaningful outcomes that have been uncovered in peer-reviewed journals. Many of the treatment plans rely on lifestyle and behavioral changes that can help prevent serious conditions from developing. Some of the most common focuses of digital Therapeutics include obesity, congestive heart failure, drug abuse, substance abuse, addiction, dementia, ADHD, depression, anxiety, and numerous other conditions.

Digital Therapeutics (DTx)

Empathogens, which are also called entactogens, refer to psychoactive drugs that create feelings and experiences of emotional openness, oneness, and interrelatedness. There are a number of drugs that fall into this category, with the most common examples including MDMA, amphetamines, phenethylamines, and mephedrone. These drugs have the potential to cause a wide variety of psychedelic and psychoactive effects including emotional communion, emotional openness, and empathy. Many of them are used during religious ceremonies and are administered by shamans, while others are taken recreationally. One of the most common examples of empathogens used for religious purposes is ayahuasca.

Empathogens & Entactogens

An entheogen is a psychoactive substance that leads to changes in consciousness, mood, perception, and behavior. Typically, this type of substance is closely related to a religious or spiritual ceremony, such as those that are closely tied to Native American and Indigenous populations. A shaman is usually responsible for building people during the religious ceremony to ensure people are having a beneficial experience. A lot of the ceremonies involving these types of substances are designed to help people achieve transcendence and divination through yoga, sensory deprivation, meditation, and asceticism. Many of these substances fall into a special category of controlled substances, allowing indigenous populations to use them if they play an important role in a religious ceremony or spiritual event.

Entheogen

A hallucinogen is an agent with a psychoactive effect. A hallucinogen binds to receptors in the central nervous system to exert its impacts on an individual. There are a number of hallucinations that can develop following the administration of a hallucinogen. Some of the most common changes include changes in sight, sound, thought, consciousness, and emotion. Individuals who take a hallucinogenic compound often describe sounds blurring together, seeing vivid colors, and images changing and distorting before their eyes. Typically, these changes are not experienced with drugs that fall into other categories. Some of the most common categories of hallucinogenic agents include psychedelics, dissociative, and deliriants. There may be some overlap with other drugs, as THC is a cannabinoid that can have some degree of psychoactive effect as well. One of the most common examples of a hallucinogenic drug is LSD, which is also called acid. Hallucinogens can also play a role in certain religious ceremonies and experiences, with some people claiming that these compounds help them purge negative energy and spirits from their bodies.

Hallucinogen

A placebo refers to a treatment that is given to the control group in a clinical drug trial. In order for researchers to figure out how well the experimental treatment works, it needs to be compared to a control. In some cases, the control group may not receive anything at all. They may be given a sugar pill or some saline. In other cases, the control group may be given the currently accepted standard which the experimental drug needs to be compared against. Placebos come in many shapes and forms, and it is important to make sure the control group does not know they are getting the placebo. This is one of the reasons why blinding might be used in a clinical trial.

Placebo

The Forced Swim Test is a specific behavioral test typically used in rodents to study feelings of apathy and motivation. First, the subject’s behavior is altered in some way, typically through a drug or a synthetic device. Then, the subject is placed in a bucket of water. The longer the rodent swims in the bucket, the greater its level of motivation. On the other hand, the longer the rodent spends without moving, the greater its level of apathy. This test has been used to study a wide variety of drugs to predict their impact on the central nervous system. For example, rodents who are exposed to SSRIs have higher levels of serotonin, which could cause them to swim harder for longer, indicating that the drug could be effective at treating depression.

Forced Swim Test (FST)

5-MeO-DMT, which stands for 5-methoxy-N,N-dimethyltryptamine, is a psychedelic substance that can be found in the Sonoran Desert Toad as well as numerous plant species. The drug is commonly smoked or insufflated. The effects typically last 10 to 20 minutes when it is smoked or up to two hours if it is insufflated. The drug can lead to a feeling of euphoria and immersive experiences. 5-MeO-DMT commonly goes by slang terms including toad venom, the power, and five methoxy. It has played a role in religious ceremonies as well, most notably the Church of the Tree of Life during the 1970s.

5-MeO-DMT (5-methoxy-N,N-dimethyltryptamine)

Ergot is a fungus that grows on rye and similar plants. The fungus produces an alkaloid that leads to a specific condition known as ergotism. Ergot alkaloids are very similar to LSD. Lysergic acid serves as the precursor to LSD, and plays a key role in the synthesis of this drug. Exposure to ergot alkaloids can lead to hallucinations and significant changes in overall behavior. Some of the other impacts of exposure to ergot alkaloids include uterine contractions, seizures, nausea, high fevers, and severe vomiting. The effects of this substance depend on the timing and degree of exposure.

Ergot (Ergot fungi)

The Esalen Institute, commonly called Esalen, is a nonprofit retreat located in California. The group offers an alternative form of education, focusing on strengthening the connection between the mind and the body. The goal is to help people raise their levels of personal awareness. Today, the program offers a wide variety of workshops that focus on human psychology, spiritual awareness, and physical wellness. Recent additions include focuses on permaculture and environmental sustainability. Recently, the curriculum underwent an overhaul in an effort to make it more appealing to members of the younger generation. Some of the most common practices include meditation, mindfulness, yoga, wilderness adventures, spiritual and religious studies, and philosophical inquiry.

Esalen, or the Esalen Institute

If a drug has been given a fast track FDA designation, a research project is given access to a wide variety of resources that are designed to expedite the research and review process. If a project shows preliminary clinical evidence that a drug may be able to fill a significant unmet need, or that it is significantly better than currently accepted treatment options, then the FDA may give a drug a fast track designation. The goal of this designation is to help medications get to the open market faster, giving patients access to new diagnostic and treatment options that may significantly improve their prognoses. Companies are able to apply for Fast Track designation at any time, and the goal is to get applications through the FDA in under 180 days.

Fast Track (FDA Designation)

Good manufacturing practices, usually shortened to GMP, refers to a series of guidelines that have been put in place to regulate the sale and manufacture of a number of items including medical devices and pharmaceuticals. These practices are instituted by the FDA, and the goal is to ensure drug products are safe, effective, and easily identifiable. GMP regulations are designed to be flexible while also meeting a number of minimum requirements. A lot of drug development companies use unique approaches that surpass standards instituted by the FDA’s GMP requirements. Organizations that follow all GMP regulations typically have lower rates of contamination, errors, and mistakes during the manufacturing process.

GMP/cGMP (Good Manufacturing Practices)

The Harvard Psilocybin Project was a group of psychological experiments that were conducted by Richard Alpert and Timothy Leary. There were a number of graduate students working on the projects as well. The project was focused on the research and advocacy of psychedelic drugs, specifically psilocybin, which is a psychedelic compound found in certain types of mushrooms. One of the hallmark experiments was the administration of psilocybin compounds to inmates in the Concord Prison Experiment in an effort to reduce rates of recidivism. Another key experiment was the Marsh Chapel Experiment, which administered psilocybin in an effort to produce religious effects. The project ended in 1962 when a number of Harvard professors voiced concerns related to the legitimacy of the experiments being conducted.

Harvard Psilocybin Project

The Heffter Research Institute is a nonprofit organization (501c3) that advocates for the research of hallucinogens and psychedelics, including psilocybin, in an effort to alleviate suffering and increase understanding of the mind. The institute was founded in 1993, and handed out more than $3 million in research grants between 2011 and 2014. Many of the studies that have been funded by The Institute have focused on depression and cancer patients, anxiety related to terminal illnesses, and treatment research for those who suffer from substance abuse and addiction. Many of the studies have led to the discovery of new diagnostic and treatment options for individuals who suffer from a variety of conditions.

Heffter Research Institute

Holotropic breathwork is a specific approach to personal empowerment and self-exploration. The goal of this practice is to help people get in touch with their inner wisdom, allowing them to move forward and transform their personal being. Through holotropic breathwork, individuals will support, access, and acknowledge the inner healing that takes place within them. The overall framework unites a wide variety of insights from psychology, consciousness research, mystical traditions found throughout the world, and Eastern spiritual practices. The goal is to help people better understand themselves and others through a unique set of practices. Typically, participants have their eyes closed, laid down on a map, and focus on the music in the room and an accelerated breathing pattern to help them enter an elevated state of consciousness.

Holotropic Breathwork

Tabernanthe Iboga is a rainforest shrub found in central Africa. The plant typically grows to approximately two meters in height, but can also reach a height as high as 10 m. It is found in the Republic of Congo, the Democratic Republic of Congo, and Gabon. The plant is often cultivated in the backyards of residents before it is collected and sold at local markets. It plays a significant role in traditional African rituals and medical practices. The bark and yellowish root of the plant is hallucinogenic. The chief compound that is isolated from the root and bark is called ibogaine. It can be used to treat addiction to opioids, but it can also be dangerous if people take too much of it. Individuals who take this compound report a variety of effects, with the most common examples being auditory and visual hallucinations.

Iboga (Tabernanthe iboga)

An indication refers to anything that makes a certain type of treatment advisable. For example, individuals who suffer from symptoms of depression have an indication for treatment with therapy and a possible SSRI. Individuals who suffer from symptoms of anxiety may have an indication for anxiety treatment, such as therapy and a possible benzodiazepine. Indications come in all shapes and forms, and they are usually identified by medical professionals. There are even situations where individuals might have an indication for taking a psychedelic substance. For example, individuals who suffer from treatment-resistant depression could be given psychedelic substances in conjunction with therapy as an alternative treatment option.

Indication

Ethnopharmacology, also called ethnomedicine, refers to the study of the relationships between the human race and biologically active agents. For example, one of the major areas of study in this field is the relationship between man and plants. Specifically, the field takes a look at how plants have been used by man over the millennia. The goal of this field is to better understand how the human race has used animals, fungi, plants, and other naturally occurring compounds, applying them in a variety of ways. Many of the compounds that man used during ancient times have formed the foundation of prescription medications that we use today. This field seeks to map out that journey to see how we got here.

Ethnopharmacology (Ethnomedicine)

The head twitch response, usually shortened to HTR, is a rapid movement of the head back and forth that takes place in rodents after the 5-HT2A receptor has been activated. A variety of compounds lead to an HTR in rodents that do not necessarily lead to a similar effect in humans; however, there is usually a correlation between an HTR in mice and an HTR in humans. One of the most common examples is LSD, which leads to an HTR in humans and mice. Even though 5-HT2A receptors are commonly associated with an HTR, triggering the 5-HT2C receptors can lead to a similar response. Some of the other compounds that bind to these receptors include atropine, yohimbine, and phencyclidine.

Head-Twitch Response (HTR)

Ibogaine is a psychoactive substance that occurs naturally in a variety of plants. It is a psychedelic substance that carries dissociative properties. Early research suggests that this compound can be used to help people recover from drug addiction, but an overdose of ibogaine can also be toxic. In addition, people use ibogaine to have transcendental experiences, focusing on themselves while also getting in touch with their spirituality. Ibogaine is mainly isolated from the bark of the iboga tree, which is found throughout Africa. When people take ibogaine, the psychedelic effects typically last between four and six hours. During an ibogaine experience, people make an effort to overcome their fears and defeat negative emotions. It can lead to an altered state of consciousness that is commonly compared to dreaming.

Ibogaine

Ketamine is a prescription medication that has a role primarily as an anesthetic. Ketamine treatment leads to a dissociative state, helping people relax while also providing pain relief. When administered, ketamine can lead to changes in heart rate, breathing pattern, and airway reflexes. It can also influence blood pressure and treat depression. The different effects of ketamine are modulated by the size of the dose. Ketamine has a relatively quick onset of action and fades away relatively quickly. Ketamine exerts its impact by binding to the NMDA receptor, acting as an antagonist that blocks its activities. In addition, ketamine has been used as a recreational drug because of its hallucinogenic and associated impacts. It is frequently called Special K, and it is included on the World Health Organization's list of essential medicines.

Ketamine

A lysergamide is a specific type of chemical structure. It is an amine of lysergic acid, meaning that a nitrogen group of the base structure has been slightly altered. Lysergamides exert their effects on dopamine and serotonin receptors throughout the human body. Changes in levels of dopamine and serotonin lead to a variety of effects including changes in mood, feelings of euphoria, and possible hallucinations.

Lysergamide

MK Ultra, which is often referred to as Project MKUltra, refers to a series of illegal human experiments that were undertaken by the Central Intelligence Agency, or CIA. The overall goal of the program was to identify drugs, such as LSD, that could be administered and interrogations to weaken people's resistance to the person asking the question. Then, after identifying potential targets, these drugs would be a minister to captured spies and prisoners in an effort to extract information from them. Ultimately, the project used a variety of questionable methods to overcome someone's mental state, including psychological torture and brainwashing. Examples of tactics that were used by the people in the program include hypnosis, electroshocks, psychoactive drugs (such as LSD), isolation, and sensory deprivation. The project was stopped in 1973. The project was brought to public attention by 1975, and some of the documents have been made public. This has led to an in-depth examination of the program and a significant degree of controversy.

MK-Ultra

MAPS, the Multidisciplinary Association for Psychedelic Studies, was started in 1986 by Rock Doblin. This is a nonprofit organization with the goal of raising awareness and improving understanding of psychedelic drugs and substances. Even though the group has focused on a wide variety of drugs over the years, its main focus has been MDMA. Specifically, the group has advocated for the use of MDMA in the treatment of depression. The group received approval from the FDA to initiate phase 3 clinical trials in 2016, and the FDA eventually designated MDMA as a breakthrough treatment option for those who suffer from PTSD. The group also sponsors a wide variety of other research studies that focus on other psychedelic drugs as well.

MAPS (Multidisciplinary Association for Psychedelic Studies)

A Kambo cleansing, which is frequently referred to as a Sapo or Kambo circle, is a specific type of purge that uses skin secretions from a species of frog. The secretions are administered to trigger a psychedelic response in the individual participating in the ceremony. The ceremony originated as a folk medicine practice among indigenous populations in the Amazon. Ceremonies were led by shamans who guided others on a religious, spiritual journey. The treatment can also be given as an alternative medical treatment in the west; however, research into this type of detox is still ongoing. The ceremony usually involves burning one of the limbs before administering the secretions of the frog directly onto the burn. Proponents of the treatment claim that this type of administration can help people recover from injuries and illnesses, but research is still ongoing.

Kambo (Sapo)

Lysergic acid diethylamide, which is usually shortened to LSD, is a psychedelic drug that frequently goes by the street name acid. The effects of LSD can vary significantly from person to person, particularly including changes in emotions, thoughts, and sensory perceptions. If people take a high enough dose, some of the most common effects include increased blood pressure, dilated pupils, and an increased body temperature. LSD exerts its effects by binding to serotonin receptors and dopamine receptors throughout the body, leading to a relatively quick onset of action, particularly when compared to other substances such as psilocybin. LSD’s effects usually start within 30 minutes and can last for up to 20 hours. Some people describe a mystical experience when they take LSD.

LSD (lysergic acid diethylamide)

A magic truffle refers to the sclerotia of the psilocybin mushroom. The magic mushroom contains a wide variety of hallucinogenic chemicals, including psilocin and psilocybin. Typically, people eat the magic truffle raw, and its effects begin within 15 minutes. Usually, by 60 minutes, people start to feel psychoactive effects. If the magic truffles are made into a tea, the effects can start more quickly. Often, people describe sounds running into each other, a relaxed feeling, and a state of euphoria. Color has become more intense, and objects begin to wave back and forth. Typically, the effects last approximately 6 hours, but it can take as long as 16 hours for someone to completely return to normal. The exact length and timing of the effects depend on how much someone has taken and what their tolerance level is like.

Magic Truffle

Major depressive disorder is the scientific name given to depression. Depression is one of the most common mental health issues, and it describes a generally low mood state. Depression can present in a wide variety of ways, with some of the most common symptoms including feelings of hopelessness, a loss of interest in activities that used to bring pleasure, and a general feeling of discontent. People may have short tempers with those around them, and they may experience changes in their sleep schedules and eating habits. Individuals who suffer from feelings of depression need to seek the care of a trained mental health professional. There are a variety of treatment options for depression, but the backbone treatment is usually therapy. SSRIs can also be given as a treatment option for depression. In severe cases of depression, people can present with suicidal ideation, and some even attempt suicide. The treatment of depression is usually supervised by a trained medical professional, with particularly difficult cases of depression being treated by a psychiatrist. Other natural treatments can be effective in the management of depression as well, including exercise, changes in diet, and improved sleep hygiene. There are situations where someone might suffer from treatment-resistant depression, which could benefit from treatment with a psychedelic compound.

Major Depressive Disorder (MDD)

Mescaline is a naturally occurring proto-alkaloid psychedelic compound that falls in the class of phenethylamine. It is known for its hallucinogenic impacts, and it exerts effects that are similar to those associated with psilocybin and LSD. This compound is found naturally in the San Pedro cactus, the Bolivian torch Cactus, and the Peruvian Torch. The compound is also found in the Peyote Cactus, where it is frequently incorporated in a lot of religious ceremonies. The compound exerts its hallucinogenic impacts by binding to receptors for dopamine and norepinephrine. It also activates the serotonin 5 HT2A receptor, where it binds with a high degree of strength. Changes in serotonin levels are responsible for the effects that people feel, with some of the most common examples being auditory and visual hallucinations. People usually feel the effects of mescaline in under an hour, with the effects dissipating after ten to 12 hours, depending on the size of the dose someone has taken.

Mescaline

Microdosing refers to the administration of extremely small amounts of psychedelic drugs in an effort to treat mental health issues or increase mental performance. The goal of taking such small doses is to remove a lot of the psychedelic impacts and side effects that otherwise make it hard for people to complete their daily routines. Microdosing has been compared to the titration of other drugs administered for mental health purposes, where people try to administer very small amounts of drugs in an effort to maximize the positive impacts while minimizing complications and side effects. Individuals who engage in microdosing often try to increase their energy levels to make them more productive.

Microdosing

A mystical experience questionnaire is a survey about someone's experience with psychedelic drugs, usually completed by the individual immediately after the experience is over. The original version had 43 items, but the revised version was shortened to 30 items. The questionnaire is frequently used in research studies where psychedelic drugs are involved. The questionnaire has been in use since the 1960s, and the shortened version is still used to this day. Numerous questions focus on someone's overall emotional state, seeking to figure out how it changed before, during, and after the experience. Some people take the questionnaire regularly to chart changes in how they feel over time.

Mystical Experience Questionnaire

Neuroplasticity, which is often phrased as neural plasticity, refers to a series of neural networks in the brain. Neural networks in the brain can change, reorganize, and grow depending on experiences that people have. Sometimes, these changes can take place in only a few paths. In other cases, systematic adjustments can be made, including cortical remapping. Some of the biggest examples of neuroplasticity include learning a new ability, being exposed to environmental influences, and going through psychological stress. Originally, researchers thought that neuroplasticity could only take place during childhood. Now, research has uncovered that neuroplasticity can take place in adults as well. At the same time, the brain of a child has a greater degree of neuroplasticity than an adult brain, which is why the brains of children can recover more from brain damage when compared to adult brains.

Neuroplasticity

The NMDA receptor is a receptor in the central nervous system that is responsible for initiating downstream effects using neurotransmitters. In order for the NMDA receptor to be activated, glutamate and glycine need to be activated. Then, the magnesium molecule has to be removed from the pore of the receptor. This type of receptor plays a significant role in a variety of neurological processes, including synaptic plasticity, learning, and memory. The receptor can be triggered by a wide variety of psychoactive drugs including ketamine and PCP. When the receptor is activated, it opens, allowing ions to pass through the membrane. As ions pass through the membrane, various neurotransmitters are released, causing changes in how people feel.

NMDA Receptor (NMDAR)

A noetic quality is a term used to describe a wide variety of mystical, spiritual, and religious experiences. These are often described as noetic qualities because they can feel real to the person who is experiencing them. People have described religious, spiritual, and mystical experiences in a variety of ways over the years, leading to the abbreviation RSMEs. For example, someone who participates in a religious ceremony involving a shaman might take a psychedelic substance as a way to trigger a certain experience. This could be considered a noetic quality.

Noetic Quality

An observational study is one of the most common types of studies that takes place in social sciences. It is commonly used in statistics, psychology, and epidemiology, where a smaller sample is used to draw white or conclusions about a larger population. In this type of study, the independent variable is not under the control of the researcher because of logistical constraints or ethical concerns. For example, an observational study might take place to take a closer look at the effects of a specific type of treatment on a group of subjects. Then, the subjects are compared to a larger control group outside the overall control of the investigator. An observational study is very different from a randomized control trial, where just about every parameter of the study is under the control of those running the experiment. An observational study is a way to take a look at a cross-section of the population and is typically faster than a randomized controlled trial; however, it is subject to being influenced by confounding variables, which can make the results of an observational study less trustworthy than those of a randomized control trial.

Observational Study

An open-label clinical trial is a specific type of clinical trial where both the researcher and the individual receiving the treatment know the type of treatment being administered. This means that the participant in the research trial knows if he or she is receiving the experimental drug or the control feature. This type of study is usually done in direct contrast to a double-blind study, where neither the researchers nor the person receiving the treatment knows what type of treatment is being administered. The goal is to compare the results of an open-label clinical trial to the results of a double-blind trial to see just how effective the treatment is.

Open Label

An orphan drug designation is a specific designation given to a type of drug by the FDA. The FDA grants this destination to certain types of drugs to encourage people to pursue treatment options for diseases that impact a very low number of people, preventing them from being “orphaned,” or overlooked. An orphan drug designation is usually given to a drug that treats a condition that impacts fewer than one out of every 200,000 people in the United States. Drugs that received this designation are eligible for a wide variety of incentives including qualified clinical trials and tax credits. The goal of the program is to spur research into treatment options for diseases that are traditionally overlooked.

Orphan Drug Designation

Peyote is a specific type of cactus that contains a wide variety of psychoactive compounds, including mescaline. Peyote is found naturally in Mexico and southwestern Texas, typically growing in the Chihuahuan Desert. It flowers between March and May, but can flower as late as September, depending on the environmental conditions. Peyote is known for its wide variety of psychoactive properties when ingested. It has been used in religious, ethnic, and medicinal ceremonies by populations indigenous to North America for thousands of years. Indigenous peoples often employ peyote for the treatment of breast pain, childbirth pain, diabetes, blindness, and rheumatism. People who take peyote often report feelings of synesthesia, where rich visual and auditory effects can lead to philosophical and spiritual insights. When ingested, the effects of peyote can last between 10 and 12 hours.

Peyote

A phase 1 clinical trial is the first phase of the trial phase that involves people. Prior to starting phase one, a drug has to be shown to be safe and effective in the laboratory and animals. When a phase 1 clinical trial begins, researchers will try to find the highest dose of a drug that can be given without causing severe side effects. Typically, this type of clinical trial begins by giving everyone in the trial a low dose. Then, over time, the dose is increased to see if severe side effects begin. The main concern of a phase 1 clinical trial is safety. Everyone is watched closely to see if they develop side effects. Phase 1 trials are usually small, so severe side effects may not be detected until later in the research process.

Phase I (Clinical Trial)

A New Drug Application, frequently shortened to an NDA, is an application that companies researching and developing drugs need to fill out if they would like to formally ask for the FDA to approve a new pharmaceutical product for marketing and sale in the United States. The NDA should provide a wealth of information that shows that the proposed treatment is safe and effective for a specific condition. If treatments already exist for that specific condition, the application should demonstrate why the new treatment is more effective than existing treatments. The application also has to show that the manufacturing method and quality control procedures are adequate enough to prevent people from getting harmed by the drug and that the drug will be continually reviewed after it reaches the market.

New Drug Application (NDA)

A phenethylamine, usually shortened to PEA, is an organic compound that stimulates the central nervous system. It controls the release of monoamine neurotransmitters by binding to the TAAR 1 receptor while inhibiting the VMAT 2 transporter. This type of compound is frequently used as a dietary supplement for weight loss and mood regulation. This chemical class of compound is frequently found in over-the-counter and prescription drugs such as decongestants, antidepressants, and bronchodilators. This type of compound can also be used recreationally as a stimulant, psychedelic, and empathogen. Examples of popular phenethylamines include MDMA and mescaline.

Phenethylamines

Post-traumatic stress disorder, PTSD, is a serious mental health issue that frequently develops following a stressful experience or event. Some of the most common examples of situations where post-traumatic stress disorder may appear include following a physical assault, after a car accident, or following a tour of duty in an active combat zone. Some of the most common symptoms of post-traumatic stress disorder include flashbacks, sweating, difficulty sleeping, emotional lability, and a high respiratory rate. There are numerous treatment options for PTSD, including therapy and prescription medications. In addition, a group called MAPS is researching the effectiveness of MDMA treatment for those suffering from PTSD. The group is trying to get full FDA approval for MDMA treatment for individuals suffering from PTSD.

Post-Traumatic Stress Disorder (PTSD)

Psilocin, which is also known as psilocyn or 4-HO DMT, is a tryptamine alkaloid compound that is found in high concentrations in psychedelic mushrooms. It is a psychedelic compound that influences the transmission of serotonin throughout the central nervous system. The compound binds to 5 HT2A receptors in the central nervous system, acting as a partial agonist or full agonist. It is a breakdown product of psilocybin, and psilocin has powerful psychedelic, mind-altering effects. The overall experience of someone who ingests psilocin can vary markedly from person to person. A lot of the experiences closely resemble those related to DMT and LSD. Psilocin is a Schedule I controlled substance in the United States.

Psilocin (4-HO-DMT)

A psilocybe is a specific genus of gilled mushrooms. It is found all over the world, with numerous species in the category. The vast majority of the species in this genus contain psilocybin, which is a psychedelic compound. Most of the species in the genus are located in temperate regions, with a significant concentration in Brazil and Chile. The mushrooms grow well in moist habitats, particularly those that are landscaped using woodchips and mulch. The mushrooms become rarer in areas that are far away from areas inhabited by humans. These mushrooms can also be found in grassy and mossy areas.

Psilocybe

By the time a phase 3 clinical trial begins, the experimental treatment has shown to be safe and effective. The goal of a phase 3 clinical trial is to show that the experimental treatment is better than what is already used on the open market. During the trial, doctors do not yet know which treatment is better. Therefore, this research study usually separates participants into two groups of people. One group will receive the standard treatment while the other group will receive the experimental treatment. Then, both the researchers and the participants are blinded. This type of study is called a double-blind study, and it is important for making sure the results can be trusted. That way, no single person can manipulate the results of the study. If the new treatment is shown to be safe, effective, and more effective than currently accepted treatments, then the drug may be approved by the FDA.

Phase III (Clinical Trial)

A pre-investigational new drug meeting, usually shortened to IND, is a meeting that takes place between those sponsoring a new drug and representatives of the FDA. This is an opportunity for individuals to get some feedback on their application from FDA officials before they formally submit an application. If drug sponsors are able to get information from the FDA before they file a formal application, they may use the feedback to tweak their application, increasing the chances of the application being approved. FDA officials will take a look at the results of the research study, compare them to drugs that are currently used to treat certain illnesses and conditions, and use that information to point research sponsors in the right direction.

Pre-Investigational New Drug (IND) Meeting

Psilocybin is a potent psychedelic compound that occurs naturally. Psilocybin is produced in more than 200 species of fungi, most notably the genus of mushroom Psilocybe. When someone takes psilocybin, it is quickly metabolized into psilocin, which leads to powerful mind-altering effects. The effects are similar to those of DMT, LSD, and mescaline. Some of the most common effects experienced with psilocybin include changes in sensory perception, visual, mental, and auditory hallucinations, a distorted sense of time, and powerful spiritual experiences. Some of the most common side effects include anxiety and nausea. Psilocybin has been used since the dawn of human history. The intensity and duration of the effects of psilocybin can vary significantly depending on the type of mushroom, the dosage taken, and the tolerance of the individual.

Psilocybin

A psychedelic lysergamide is a compound that has the chemical structure of a lysergamide and leads to psychedelic effects when taken. The most common example of a psychedelic lysergamide is LSD, which is lysergic acid diethylamide. Psychedelic lysergamides tend to have very quick onsets of action when compared to other psychedelic drugs because psychedelic lysergamides activate both serotonin and dopamine receptors instead of just serotonin receptors. The exact duration of the effect can vary depending on the type of lysergamide taken. Some of the most common effects of the compound include visual hallucinations, auditory changes, and alterations in sensory perception.

Psychedelic Lysergamides

Psychedelic phenethylamines are compounds that have the chemical structure of a phenethylamine and have psychedelic effects. The most common example of this type of compound is mescaline. Some phenethylamines occur naturally in nature, while others are synthesized in a laboratory. These compounds work by influencing the transmission of neurotransmitters such as norepinephrine and dopamine. The experiences associated with these types of compounds can vary markedly from person to person, with some people stating that they have spiritual or transcendental experiences when they take psychedelic phenethylamines. Some of these compounds are even used in religious ceremonies. Specifically, mescaline binds to 5 HT2A and 5 H2TC receptors.

Psychedelic Phenethylamines

Psychedelic tryptamines are tryptamine compounds that have psychedelic properties when they are taken. The most common examples of psychedelic tryptamine are psilocybin and DMT. Tryptamines are metabolites of tryptophan, one of the essential amino acids. Not all tryptamines have psychedelic properties, but some of them do. Psilocybin is found naturally in mushrooms, and DMT is found naturally in plants and shrubs, particularly those that grow in the Amazon basin. Psychedelic tryptamines work by influencing the transmission of neurotransmitters throughout the nervous system, including serotonin. Some of the most common effects associated with these types of compounds include changes in visual and auditory sensation.

Psychedelic Tryptamines

A psychedelic refers to a specific class of hallucinogenic drugs that lead to changes in consciousness. Colloquially called “trips,” the vast majority of psychedelic compounds bind to serotonin 2A receptors. Some of the most common symptoms associated with psychedelic trips include auditory changes, visual hallucinations, and changes in overall states of consciousness. Some of the most common examples of psychedelic compounds include DMT, psilocybin, LSD, and mescaline. Most psychedelic drugs are classified as lysergamides, phenethylamines, and tryptamines. All of them bind to serotonin 5 HT2A receptors, which influence the flow of serotonin throughout the central nervous system. Psychedelic experiences can vary significantly depending on the compound taken, the dose taken, and prior experiences of the individual.

Psychedelic

Psycholytic refers to a specific type of therapy in which low doses of psychedelic drugs are given repeatedly at short intervals over a period of one to two weeks in an effort to get a steady state of psychedelic drugs in the system at a relatively low level. Typically, a clinician is present when the largest dose is given to ensure the patient has assistance in processing the effects of the therapy. The original belief behind the therapy was that it could dissolve negative thoughts and issues in the mind. Then, with genuine psychotherapy, the treatment of mental health issues could be more successful. This type of therapy used to be practiced regularly in Europe and the United States.

Psycholytic

A psychonaut is someone who studies the field of psychonautics, where individuals study changes in an individual’s state of consciousness. It focuses on different holotropic states, including those that are triggered or induced by meditation and mind-altering substances. There are numerous cultures that explore altered states of consciousness, including shamanism and Tibetan Buddhism, and all of them fall under the category of psychonautics. Anyone who uses altered states of consciousness as a vehicle to explore the human condition is known as a psychonaut. This is a vast field with numerous specialized areas and has been practiced since the dawn of human existence.

Psychonaut

Psychotomimetic refers to any drug that can mimic symptoms of psychosis, such as delusions and delirium, but does not lead to hallucinations. There are numerous drugs that have this type of effect. For example, many opioid drugs have psychotomimetic effects because they lead to delusions without hallucinations. There is also some evidence that certain cannabinoids can be psychotomimetic, including delta THC. Some hallucinogens will initially trigger hallucinations, but could leave the individual with residual psychotomimetic effects after the hallucinations fade into the background. It is also possible for psychotomimetic drugs to lead to other symptoms as well, such as apathy, avolition, and anhedonia.

Psychotomimetic

Rape, also known as shamanic snuff, is a specific type of tobacco that is distinct from the type of tobacco that is found in cigarettes. Unlike cigarettes, this type of tobacco is not typically smoked. Instead, most people snuff the compound into their noses. Once the plant is harvested, the components are pulverized and strained to create a fine, light-colored powder. Snuff is frequently used in religious and secret experiments, but the exact recipe used can vary significantly from culture to culture. The compound dates back to the time of the Incas, and it is still used in spiritual ceremonies to this day.

Rapé (Snuff)

A reducing valve is a specific type of regulatory device that reduces the air pressure throughout the rest of the machine. It can be used in the production of drugs to control the amount of pressure being applied to a specific mixture. Reducing valves come in many shapes and forms, and they can be customized to meet the needs of the specific production process. Reducing valves typically have a wheel or a nozzle that can be physically adjusted, along with a barometric gauge that lets the user know exactly what the pressure is as the nozzle is turned.

Reducing Valve

Sananga is a medication used by tribes native to the Amazon. It is turned into a drop that is administered directly to the eyes. While it can improve vision at night, which is helpful for hunters, the compound has also been used in religious ceremonies. The compound is frequently used prior to ceremonies with ayahuasca in an effort to cleanse negative energy from the body. It is thought that Sananga can also give users a greater degree of spiritual insight during the rest of the ceremony. Its effects can increase sensory perception and make colors appear sharper.

Sananga

Sclerotia, which is the plural or the singular sclerotium, is a compact piece of mycelium that has hardened over time. It typically contains food reserves, and sclerotia are incredibly durable, able to stand up to adverse environmental conditions. In some situations, sclerotia can detach from the rest of the plant and go dormant until more favorable environmental conditions arise. The sclerotium of the magic mushroom psilocybin is a psychoactive mycelium. Even though this specific sclerotium contains a lower level of psilocybin when compared to the rest of the mushroom, it can still lead to a short, powerful trip. Some of the most common effects associated with this mycelium include sensory changes, mystical experiences, and a transcendental, spiritual experience.

Sclerotia

Section 56 is a specific section in the Canadian Controlled Drugs and Substances Act, or CDSA, that gives the Minister of Health in Canada the power to provide exemptions to this act to certain individuals if he or she believes that a specific substance is required for a scientific or medical purpose. The minister can also provide an exemption if he or she believes that the exemption is in the interest of the public. For example, some individuals might be granted permission to take psychedelic drugs that are covered by the CDSA if they can prove to the minister that the substance would help them recover from a serious condition. These cases are often put before the minister in conjunction with a trained and experienced medical professional.

Section 56 (Exemption)

Set and setting are two important components during a psychedelic experience. The set refers to someone’s mindset as they take a psychedelic substance or undergo an experience. Setting refers to the external environment, usually the social environment, in which the person is located. Someone’s overall mindset during the experience can play a significant role in what they feel. The experience can also be influenced by the social setting in which people take the psychedelic substance. Set and setting can also play an important role as someone receives treatment for a mental health issue. Changing the set and setting can change someone’s experience even if they take the same substance.

Set and Setting

Salvia divinorum, which is also called sage of the diviners, is a specific plant in the Salvia genus that contains psychoactive properties. The psychoactive compounds are contained in its leaves, and the properties can be triggered by smoking the leaves, chewing them, or turning them into a tea. The leaves contain a variety of compounds that resemble opioids, and some of them can lead to hallucinations. The plant usually grows in shady locations spread throughout Mexico. When mature, the plant can stand over a meter high. Shamans have a long history of using this compound to trigger altered states of consciousness during religious ceremonies. The main psychoactive compound is salvinorin A, and it is a potent agonist of kappa opioid receptors. The compound has a relatively quick onset of action, and the effects dissipate quickly.

Salvia Divinorum (Salvia)

A randomized control trial is a specific type of research experiment in which scientists attempt to control factors that are not under direct experimental control. This type of trial carries significant evidentiary weight because it minimizes the chances of outside influences changing the results of the experiment. There are numerous situations where a randomized control trial might be used, including during the process of drug development. During this trial, participants are allocated to different groups that receive different types of treatments. The researchers will try to keep most factors uniform so that any differences in the outcomes of the group can be attributed to specific variables that are being altered, such as the type or dosage of drug administered. The ultimate goal is to control confounding factors to deliver a useful comparison that can help researchers draw conclusions from the experimental change.

Randomized Control Trial (RCT)

Accelerated approval refers to the pace at which some drugs can be approved by the FDA. Accelerated approval was first introduced in 1992. If the drug is being produced to meet a serious condition, and it can meet a serious medical need, a drug may qualify for accelerated approval. Of note, there also has to be an objective surrogate endpoint marker such as a physical sign, a radiographic image, or a specific laboratory measurement, that indicates the treatment is working better than currently approved treatments. If a drug meets all of these conditions, then it may reach the open market faster pursuant to FDA approval. Confirmatory clinical trials are still required, and if they show that the drug is indeed working as intended, then the FDA may issue conventional approval on top of the drug’s original accelerated approval.

Accelerated Approval

Serotonin is a neurotransmitter that is released by nerve endings and cells in the central nervous system in the brain. Serotonin is responsible for regulating moods and plays a critical role in the reward functions of the nervous system itself. Serotonin is regulated by molecules that bind to 5 HT2 receptors in the brain, and it is made in the raphe nucleus, located in the brainstem. Many psychedelic drugs regulate serotonin levels to cause their psychoactive effects. Some of the most common drugs involved in this process include psilocybin, mescaline, and LSD. Serotonin is also a common target of mental health treatments and therapies.

Serotonin

Cannabis, which is also known as marijuana, is a plant that has compounds that have been used for millennia for recreational and medical treatment purposes. There are hundreds of compounds that have been isolated from this plant, with THC and CBD being the two most common. THC stands for tetrahydrocannabinol. It is responsible for the psychoactive impacts of the plant. CBD stands for cannabidiol. This is the other main compound that has been isolated from the plant, and it can be used in the treatment of a variety of issues. Cannabis can lead to a variety of mental and physical effects. People use cannabis by smoking, vaping, mixing it in food, or isolating it as an extract. Cannabis compounds can enter and leave the system at different rates depending on how they are taken. In general, people who inhale cannabis feel the effects faster than those who mix cannabis in with their food. Marijuana is the colloquial name given to cannabis, a plant that has been used for thousands of years by humans for recreational and medicinal purposes. There are hundreds of compounds that can be isolated from marijuana. Two of the most common examples include THC, which stands for tetrahydrocannabinol, and CBD, which stands for cannabidiol. Marijuana can be administered in a wide variety of ways. Some people mix it into their food and beverages, while other people apply it directly to the surfaces of the skin. Some people prefer to smoke or inhale it while other people turn it into a substance they can place directly under the surface of the skin. THC is responsible for the psychoactive effects of marijuana, while CBD is a common target of research for therapeutic purposes.

Cannabis

Acid is the colloquial name given to lysergic acid diethylamide, usually shortened to LSD. This is a psychedelic drug that binds to receptors in the brain. It can cause different reactions in different people, with some of the most common impacts being changes in sensory perception, emotions, and intensified thoughts. If the dosages are particularly high, LSD can lead to auditory and visual hallucinations. Some of the other impacts include increased body temperature and dilated pupils. In the central nervous system, LSD binds to the dopamine and serotonin receptors. Because it binds to more receptors, it can have a faster impact on someone when compared to other drugs, such as psilocybin. Typically, individuals begin to feel effects within 30 minutes. Its impacts can last up to 20 hours, but the exact length of the effects depend on how much someone takes and what their tolerance is like.

Acid

MDMA is the scientific name for ecstasy, which also goes by the street name Molly. The compound was synthesized by Merck in the early 1900s, but it never reached the market. Eventually, the compound was synthesized in a local home in San Francisco. MDMA exerts a wide variety of empathogenic qualities. The drug has been listed as a Schedule One substance in the United States for many years, indicating that it has a high potential for abuse; however, recent research indicates that the drug could have potential therapeutic benefits in the treatment of PTSD. The FDA labeled MDMA as a breakthrough treatment option in the treatment of PTSD, spurring further research into the compound. Individuals who take MDMA often report feelings of increased energy, changes in sensation, and feelings of pleasure. The effects usually start in approximately 30 minutes, and they tend to dissipate in approximately six hours.

MDMA (3,4-methylenedioxymethamphetamine)

The controlled substances act, or CSA, was signed into law in 1970 by then-President Richard Nixon. The act established a federal drug policy by breaking compounds into five schedules, or groups. Each schedule has its own set of restrictions and penalties. While drugs have changed classes over the years, the strictest group is Schedule I, which also has the harshest penalties. Drugs that fall into Schedule I are widely accepted to have a high potential for abuse. Drugs that were originally included in Schedule 1 include LSD, psilocybin, cannabis, MDMA, and DMT. Substances classified as Schedule II have a high potential for abuse but do have accepted medical applications. Examples include painkillers such as hydromorphone and morphine. Schedule III substances have some potential for abuse but have less potential than drugs that fall into Schedule I and II. Examples of drugs that fall into Schedule III include testosterone and ketamine.

Controlled Substances Act (CSA)

An investigational new drug is a specific label that is conferred to a drug that is in development. The label is given by the FDA, and it is a process the FDA uses to see if a drug should be allowed to start clinical trials in humans. Typically, an investigational new drug has to have a significant body of evidence of crude from multiple research studies. These studies usually take place in laboratories and in animals. If the FDA gives the go-ahead for an investigational new drug to begin human clinical trial, trial sites are established, experimental drugs are produced, and the trial proceeds under close supervision to see how effective it is and whether any side effects or complications begin to develop. After human clinical trials have been completed, the FDA will review the evidence to see if the drug warrants full approval.

Investigational New Drug (IND)

The open field test was developed by Calvin S. Hall, and this is an experimental test that is used to explore the anxiety and willingness of animals in scientific research. For example, some researchers use the open field test to assess the memory of animals in recognizing certain objects and stimuli. Researchers have uncovered that lower levels of anxiety in animals lead to more exploratory behavior. On the other hand, an increased level of anxiety will lead to reduced locomotion, meaning that animals prefer to stay within the closed walls of the field itself. Researchers who conduct this type of test measure a wide variety of parameters including rearing, stretch attend postures, defecation, and urination.

Open Field Test (OFT)

A selective serotonin reuptake inhibitor, usually shortened to SSRI, is a drug used to treat a variety of mental health issues, mainly depression. SSRIs, when administered, block serotonin from departing the central nervous system, effectively raising levels of serotonin in the brain. Higher levels of serotonin can elevate people’s moods, helping them feel better while allowing them to manage and overcome symptoms of depression. SSRIs are typically more effective when they are combined with therapy. Some of the most common examples of SSRis include Celexa, Prozac, Paxil, Zoloft, and Lexapro. In addition to depression treatment, SSRIs can also be used to treat certain types of anxiety, such as social anxiety disorder, or SAD.

SSRI (Selective Serotonin Reuptake Inhibitor)

A designer drug is a drug that has been synthetically developed by someone with the intention of closely mimicking another controlled substance to have the same effects. People try to create a synthetic drug that has the same effects in an effort to evade detection in typical drug tests or get around drug classification laws. Designer drugs can be very dangerous because they are typically made in clandestine laboratories and are not thoroughly tested before they are taken by someone. These drugs are typically called bath salts or plant food, with some specific examples being K2, Spice, Krypton, Lava Red, and Banana Cream Nuke. These drugs are often cut or mixed with other compounds that could make them even more dangerous, and overdosing on these substances can lead to serious side effects.

Designer Drugs (Research Chemicals)

PCP, which goes by a variety of street names, including angel dust, is a dissociative hallucinogenic drug that can lead to significant mind-altering effects. Some of the most common impacts of PCP include hallucinations, major changes in the perception of sound, feelings of superhuman strength, and extremely violent behavior. Even though this recreational drug is usually smoked, it can also be injected, snorted, or taken by mouth. Some people also mix PCP with tobacco or cannabis. Some of the side effects of PCP include coma, seizures, addiction, and an increased risk of suicide. PCP is a Schedule 2 drug in the United States, and some derivatives of PCP had them sold for nonmedical and recreational use. PCP can also cause people to develop schizophrenia, which is a mental health issue that leads to psychosis.

PCP (Phencyclidine)

If the experimental treatment was found safe during phase 1 clinical trials, it will be given the green light to move forward to phase 2 clinical trials. Whereas phase 1 clinical trials focus on whether the experimental drug is safe, phase 2 clinical trials focus on whether the experimental drug is effective against its targeted condition. A phase 2 clinical trial is usually larger than a phase 1 clinical trial. Because larger numbers of people are taking part in a phase 2 clinical trial, more side effects might be detected that were not seen in a phase 1 clinical trial. These new side effects will be evaluated along with other endpoints in a phase 2 clinical trial. If new side effects detected are not that bad, and the treatment is shown to be effective, then the treatment will be given the green light to move forward with a phase 3 clinical trial.

Phase II (Clinical Trial)

The 5 HT2A receptor is a receptor in the brain that binds to serotonin. It is a G Protein-Coupled Receptor, or GPCR, meaning that when the receptor binds to its target molecule, a G-protein is released into the central nervous system to trigger downstream effects. This receptor is a common target of psychedelic drugs, including psilocybin mushrooms and LSD. Some psychedelic drugs are described as 5 HT2A agonists, meaning that they bind to this receptor with a high level of affinity. The receptor has also been studied by scientists who are interested in the relationship between this receptor and SSRIs, which are commonly used in the treatment of depression. Research has shown that patients with depression and a history of suicidal ideation have more 5 HT2A receptors than patients without these mental health issues, which could indicate that this receptor plays a role in mental health problems and treatment. The receptor is a common target of those seeking treatment for mental health issues, as it controls the flow of neurotransmitters responsible for mood regulation, such as serotonin.

5-HT2A Receptor

An MAOI is a monoamine oxidase inhibitor. This is a specific class of drug that inhibits the ability of one or both of the monoamine oxidase enzymes, which are called MAO A and MAO B. MAOIs are usually administered for the treatment of depression, but they can also be very effective in the treatment of panic disorder and social phobia. MAOIs can be administered for the treatment of atypical depression, treatment-resistant depression, and Parkinson's disease. This class of drug can also lead to significant side effects, including a potential hypertensive crisis. For this reason, people who take MAOIs need to stay away from foods and beverages that contain tyramine. Some of the most common sources of tyramine include salami, soy sauce, and cheese. If large amounts of tyramine are ingested with MAOI medications, people's blood pressure can rise to unsafe levels.