A
Accelerated Approval
A set of regulations instituted in 1992 by the FDA. The process allows for expedited approval of drugs that treat serious conditions, “and that fill an unmet medical need based on a surrogate endpoint. A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit (i.e., a proxy of sorts). The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval” (FDA). Phase 4 confirmatory trials are still required (see Phase IV, below). Should these trials confirm the drug provides the expected clinical benefit, the FDA approves the drug in the conventional manner. However, should the confirmatory trials fail to demonstrate clinical benefit, the FDA may remove the drug from the market.
Active Placebo
Active placebos are designed to trick a study participant into believing they have received the psychoactive drug under investigation. Niacin is a popular choice among psychedelic researchers, as it produces a tingling sensation. Active placebos are particularly useful in trials and studies involving the use of psychedelics, as otherwise, the very existence of psychoactive effects would likely compromise the blinding of the trial.
Adaptogenic Mushrooms
Mushrooms are traditionally used to reduce the effects of stress on the body. Adaptogenic mushrooms are not hallucinogenic and do not act on the mind or perception.
Adnate or Adnexed
Gills that are broadly attached to the stem are called adnate. Gills that are narrowly attached to the stalk are called adnexed.
Afterglow
A state characterized by positive physical and mental effects that persist after the primary effects of a drug have subsided, described by Walter Pahnke as a period of ‘elevated and energetic mood with a relative freedom from concerns of the past and from guilt and anxiety.’ During the afterglow period, the effectiveness of psycho-therapeutic interventions is reported to be enhanced until the afterglow gradually subsides after a period of between two weeks and a month (see Majić et al., 2015 for discussion).
Agonist
Partial – A partial agonist will activate a receptor, but only have partial efficacy compared to a full agonist. For example, fentanyl is a full mu-opioid receptor agonist that can elicit maximal receptor response, while buprenorphine (an opioid use disorder management drug) is a partial mu-opioid receptor agonist.
Inverse – An inverse agonist will bind to a receptor at the same site as an agonist but induce a pharmacological response that is opposite to that of the agonist. One requisite is that the receptor must have basal levels of activity, such that an agonist will increase activity, and an inverse agonist will decrease activity. Note that the effects of both can be blocked with an antagonist.
AA+ Albino
Although not a true albino genetically speaking, who cares, they are gorgeous white mushrooms and the albino name for this cubensis has stuck. Other than true albinos, which are rare in nature, this strain of cubensis produces white mushrooms time after time, no other cubensis does this! These are the HOT BLONDE of cubensis mushrooms.
Amanita Muscaria
Famous, enchanting, and highly toxic. Fly agaric is the home of fairies and magical creatures and a lover of birch woodland, where it helps trees by transferring nutrients into their roots, but if eaten can cause hallucinations and psychotic reactions. Fly agaric has a long history of use in religious ceremonies, particularly in Asia. For over 4,000 years it was the ingredient in a sacred and hallucinogenic ritual drink called 'soma' in India and Iran; while the Siberian shamans would give it out as a gift in late December. This toadstool has turned up in many fairy tale stories and features in the story of Alice in Wonderland when she is given some fly agaric to eat.
Administrators
Any individual, including oneself, who administers a psilocybin dose. IN OREGON: Also known as a Facilitator.
Anxiolytic
A medication (or other intervention) that reduces anxiety. The antonym is anxiogenic; an agent that increases anxiety.
Ascomycota
Ascomycota is a phylum of the kingdom Fungi that, together with the Basidiomycota, forms the subkingdom Dikarya. Its members are commonly known as the sac fungi or ascomycetes. It is the largest phylum of Fungi, with over 64,000 species.
Awareness
In psychology - awareness is a concept about knowing, perceiving, and being cognizant of events. Another definition describes it as a state wherein a subject is aware of some information when that information is directly available to bring to bear in the direction of a wide range of behavioral actions. The concept is often synonymous with consciousness and is also understood as being consciousness itself. The states of awareness are also associated with the states of experience so that the structure represented in awareness is mirrored in the structure of experience.
Ayahuasca
A plant psychedelic is traditionally used by indigenous peoples in South America for ceremonial and spiritual purposes. The primary psychoactive component of ayahuasca is DMT (N, N-Dimethyltryptamine). A brew made from a mixture of plants native to the Amazon basin, which is used by indigenous peoples of South America as a sacrament. The brew typically contains Banisteriopsis caapi vine and the Psychotria viridis shrub, also known as chacruna. The former contains MAOIs, which orally activate the DMT in the latter. A broad range of other species of plant contain DMT, so the mixture is not always as such.
In a landmark 2006 decision (Gonzales v. O Centro Espírita Beneficente União do Vegetal; notes on the case) the U.S. Supreme Court allowed the use of ayahuasca by the União do Vegetal, or Union of the Plants, a religious society founded in 1961. The decision was made in light of the Religious Freedom Restoration Act, and a Santo Daime Church in both Oregon and Montreal has since received exemptions to use ayahuasca.
B
B+
B+ is a very easy-to-cultivate and fast-growing strain. Ideal growing circumstances are best if you want to create really large mushrooms, especially a substrate that is rich in nutrients. A really big caramel-colored cap will be formed then. But, these mushrooms will also grow quite well under mediocre conditions.
Breakthrough Therapy
A process designed to expedite the development and review of drugs intended to treat a serious condition. Awarded when preliminary clinical evidence indicates that the new therapy has the potential to provide a substantial improvement over available therapies (FDA).
Breakthrough Therapy Designation
Psilocybin-assisted therapy (twice: COMPASS Pathways and Usona Institute) and MDMA-assisted therapy (MAPS) have both received this designation. Spravato, an esketamine nasal spray product for the treatment of depression, received a Breakthrough Therapy designation and was approved in 2019 (FDA).
Basidiomycota
Basidiomycota is one of two large divisions that, together with the Ascomycota, constitute the subkingdom Dikarya within the kingdom Fungi.
C
Cap
The mushroom cap, also known as the pileus, is the structure on top of the mushroom that holds the gills or pores. They come in different shapes, sizes, and textures. They can be smooth or covered with scales or teeth. The shape of a mushroom cap is unique from species to species, which is helpful for identification.
Ceremonial Experience
Ceremonial experiences with psilocybin as an experience/session that is part of an indigenous community's spiritual process around using psilocybin. This process usually involves more than taking psilocybin and may include pre, during, and post-activities/actions centered around connecting to a natural spirit in their belief system. In the broader community, the term ceremony or ceremonial experience refers to a sitter's/guide's personal process for facilitating a session. This may include indigenous practices or be self-created.
Chaga
Alternative practitioners believe that Chaga offers numerous health benefits. Among them, Chaga is believed to fight inflammation, lower blood sugar, reduce blood pressure, alleviate arthritis, and even prevent or slow the progression of cancer. Chaga is rich in fiber and essential nutrients, including vitamin D, iron, magnesium, potassium, manganese, and calcium. Chaga's high melanin content has led some to believe that it can bolster the melanin naturally found in the skin, thereby protecting it from sun damage, Skin cancer wrinkles, or aging. Melanin is also a potent antioxidant and has one of the highest oxygen radical absorbance capacity (ORAC) scores of any food. (ORAC is a method developed by scientists at the National Institutes of Health to measure the antioxidant capacity of different foods.)
Clinical Trials
U.S. Food and Drug Administration trials involving research participants are conducted in phases after drug discovery and preclinical studies, where researchers test the safety of a drug, look for side effects, calibrate dosage, and determine drug efficacy. cf. drug discovery, preclinical trials.
Cluster Headaches
Short, but incredibly painful headaches that can occur on a daily basis for weeks, or even months, at a time. Unlike a typical headache, cluster headaches are concentrated on one side of the head and are often accompanied by other symptoms including, but not limited to, irritated eyes, runny nose, and facial sweating. Psychedelics, including psilocybin and LSD, are being examined as possible treatments (see, for example, Andersson et al., 2017; see also Cluster Busters, a nonprofit supporting research for better treatment for cluster headaches, including psychedelics).
Compassionate Use
The common name for the U.S. Food and Drug Administration’s “Expanded Access” program which serves as a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational new drug product, including psychedelic drug products.
Controlled Substances Act (CSA)
Federal legislation was signed by U.S. President Richard Nixon in 1970. The CSA segregates a host of drugs into five schedules. Many psychedelic substances are listed on Schedule I, and are consequently deemed the most strictly controlled. The Statute, signed into law in 1970 by Nixon, established federal U.S. drug policy regulating certain substances according to five schedules (or, classifications). Each schedule carries associated restrictions and penalties, with Schedule I being the most severe. LSD, psilocybin, psilocin, mescaline, peyote, MDMA, cannabis, and DMT became Schedule I drugs, labeling them as ‘drugs with no currently accepted medical use and a high potential for abuse.’
Controlled Substances Schedules
Categories of controlled substances under the Controlled Substances Act, ranging from Schedule I to Schedule V. Schedule I is the most restricted and includes many psychedelics.
Cubes
Street or slang term for Psilocybe Cubensis mushrooms
Cyanesce
Psilocybe Cyanescens is the sister species to the psilocybe azurescens and is also native to the Pacific NW USA and is now spread through many countries in Europe. It's nickname is "wavy caps" as you can see by it's wavy looking caps, very cool! It's a cold weather wood-loving species and thrives in the Seattle area due to the alder mulch used in landscaping. The Psilocybe Cyanescens does not just thrive in Washington state though, as so many mushroom pickers have spread the spores along the western states and Canada. This species has really adapted to change and tends to be one of the most popular species of psilocybin mushrooms to find in Oregon and Washington. In Paul Stamet’s book "Psilocybe Mushrooms of the World", Paul points out how so many mushroom pickers were being arrested for trespassing in the '70s and the people were carriers for spores to the police station and courthouses. Paul writes this area became one is his favorite areas for picking Psilocybe Cyanescens mushrooms! How ironic and funny.
D
Decriminalization
A process or status by which a criminal law or penalties imposed for violating a criminal law are reduced, reclassified, removed or disregarded, or by which law enforcement is directed to re-prioritize the enforcement of such laws. It generally does not completely remove the criminal status of a prohibited act. When referencing a drug (like psilocybin), this refers to an area's legal decision to refrain from prosecuting an individual's possession of a small amount of a drug. NOTE: Decriminalization does NOT equal legalization and does not refer to the sale of the drug.
Dissociative Anaesthetics
Dissociative anesthetics are a class of hallucinogens that produce notable effects such as depersonalization (separation of the self from the body), derealization (the belief that the natural world is not real), hallucinations and sensory deprivation. NMDAR antagonists such as ketamine and PCP induce dissociative anesthesia. While these drugs have been preferentially used as general anesthetics, they have also been investigated for their antidepressant properties in the treatment of suicide ideation and major depressive disorder (MDD).
DMT
N, N-Dimethyltryptamine. A psychedelic chemical found in certain plants, such as ayahuasca, which is listed on Schedule I of the Controlled Substances Act. A hallucinogenic compound found in many plants and animals, and included in ayahuasca brews (see above). A DMT trip is considerably shorter than that of other psychedelics, often lasting just 15 minutes (see Kaplan et al., 1974). In short, the effects are often intense (see Carbonaro and Gatch, 2016).
Dopamine
Dopamine is a neurotransmitter released by axon terminals that has widespread regulatory function in the brain. The molecule contributes to movement, learning, reward valence, motivation, mood states, and predicting internal states. While dopamine is most attributed to pleasure by the media and public, the more nuanced pharmacological view is that it contributes to motivational salience – the neurotransmitter will modulate how an organism views predictors of an outcome (whether it was desirable or aversive) and thus, either propel it to further achieve or avoid the predictor that achieves the outcome. This theory of dopamine can be applied to drug-taking behavior, but also to other facets of learning.
Drug Discovery
The first of three major steps is in U.S. Food and Drug Administration drug research, where researchers look for chemicals that could have positive effects on the human body. Cf. Preclinical studies, clinical trials
Drug Enforcement Administration (DEA)
A U.S. federal agency housed within the U.S. Department of Justice and established in 1973 during Nixon administration. The DEA enforces the Controlled Substances Act.
Drug Enforcement Administration Registration
The U.S. Drug Enforcement Administration requires certain persons, entities, and organizations to register with the agency in order to manufacture, import, distribute, store, prescribe, and/or administer certain drugs on the Controlled Substances Act schedules.
E
Ecstasy or MDMA
3,4-methylenedioxy-methamphetamine. A synthetic drug that was added to the Controlled Substances Act on Schedule I by the U.S. Drug Enforcement Administration regulatory action in 1985.
Endospore
A metabolically dormant state of Bacteria in which they are more resistant to heat, chemicals, etc.
Enzyme
A protein, synthesized by a cell, that acts as a catalyst in a specific chemical reaction.
Empathogens, Entactogens
Psychoactive drugs generate feelings of empathy or sympathy for the subject, such as feelings of oneness, emotional openness, etc. MDMA is the drug most commonly associated with this class.
Entheogen
Synthetic and organic substances that are psychoactive and cause psychedelic effects for spiritual or religious purposes.
Esketamine
A synthetic substance first synthesized in the 1960s similar to ketamine and is used for depression (in Spravato) and as an anesthetic (in Ketanest).
F
Fermentation
In mushroom cultivation the process of composting. Easily accessible nutrients will be degraded by microorganisms which makes the Substrate more selective. Unwanted fermentation may occur if the Compost is still very 'active' or if thick layers or large bags are used. In that case, the temperature inside the Substrate will rise too high for the desired Mycelium.
Fractional Sterilization
A Sterilization method is used to destroy Bacteria and Spores in preparation of grain spawn (rye, wheat, birdseed...) which requires no Pressure cooker. In this case, the jars fitted with a filter or a Polyfil lid filter are boiled or steamed at 212°F (100°C) for 30 min in a covered pot, three days in a row. Between the boiling steps the jars are best kept warm, around 30°C, to allow the remaining Spores to germinate. The basic principle behind this method is that any resistant Spores should germinate after the first heating and therefore be susceptible to killing during the second and third heating.
Fruiting Body
A mushroom. The part of the mushroom that grows above ground.
Functional Mushrooms
Non-psychoactive mushrooms, such as Chaga, Cordyceps, Lion’s Mane, Reishi, Shiitake, and Turkey tail, have other health benefits and are often marketed as foods or dietary supplements.
Fungus
A group of organisms that includes mushrooms and molds. These organisms decompose organic material, returning nutrients to the soil.
Fungicide
A class of pesticides used to kill fungi, primarily those which cause diseases of plants.
G
GMP/cGMP (Good Manufacturing Practices)
A series of practices devised to ensure coherence to guidelines recommended by agencies that control the manufacture and sale of items including pharmaceuticals and medical devices, such as the FDA. These regulations work to ensure the identity, strength, quality, and purity of drug products. Designed to be flexible, GMP regulations are minimum requirements, and many drug development companies use innovative approaches and technologies that surpass given GMP standards.
Golden Teacher
This cubensis was first discovered on a farm growing in a pile of dung and straw in the US state of Georgia. Although there is no psilocybin or psilocin or anything else hallucinogenic in spores, Georgia still outlawed psilocybe mushroom spores from being imported into the state. Although not entirely bad news for Georgians as cubensis grow wild throughout their state. The Golden Teachers cubensis strain does not grow huge dinner plate-sized shrooms, but it throws off an abundance of small to medium-sized mushrooms. We have the original genetics of the true Golden Teachers cubensis mushrooms from the original spores going back to the Georgia farm.
Grievance Review
A grievance review process would involve a governing board or entity that is able to receive complaints from the public and provide resolution and consequences for any improper actions.
H
Hallucinogen
A subclass of psychoactive drugs that generally causes hallucinations.
Harm Reduction
Psychology Today defines harm reduction as an approach to treating those with alcohol and other substance-use problems that do not require patients to commit to complete abstinence before treatment begins. Instead, an array of practical strategies are deployed to reduce the negative health and social consequences of substance use, and psychotherapy aims to change behavior according to the goals of each patient, whether that means moderation of use or complete abstinence.
Currently, the harm-reduction model is the only option available for those seeking PAT both with mental health counselors and in the underground movement. source: pata-us.org
I
Ibogaine
A naturally occurring psychoactive substance with dissociative properties found in plants such as Tabernanthe iboga. While it has historical roots in healing ceremonies and initiations in West Africa, the psychoactive is also used in efforts to overcome substance misuse and addiction via the temporary elimination of cravings. Ibogaine is a dissociative psychedelic with oneiric properties that has multiple aforementioned anti-addictive mechanisms, as well as the ability to generate therapeutic psychological insights, suggesting promise in treating alcohol use disorders. Ibogaine is known for treating alcohol addiction. source: Science Direct
Indication
A medical condition that makes a particular treatment or procedure advisable. Examples include major depressive disorder, treatment-resistant depression, cluster headaches, and PTSD.
Informed Consent
Informed consent is a process of communication between you and your provider or psilocybin administrator that often leads to agreement or permission for care, treatment, or services. Every consumer has the right to get information and ask questions before procedures and treatments.
IN OREGON: Informed Consents are essentially liability release forms similar to what you would use for skydiving or other potentially dangerous activities designed to absolve the provider of services from liability if harm is received by the consumer or client. Licensed Mental Health Providers are bound by additional safeguards to protect your health and safety. Oregon Psilocybin Services facilitators are obligated to have you sign an Informed Consent form, with additional documents per the discretion of the licensed facility. Please be aware this may affect you if issues arise during your session/experience.
Integration
Processing and understanding the thoughts, feelings, and insights gained from using psilocybin after you have used it.
Investigational New Drug (IND)
An FDA program that allows pharmaceutical companies to obtain permission to start human clinical trials and obtain an exemption to federal law to be able to ship the drug across state lines.
K
Ketamine
A synthetic compound is generally used as a dissociative anesthetic. Its fast-acting pain relief and short-term memory loss properties make it a popular anesthetic for medical procedures and injuries sustained in combat environments. More recently, lower doses of ketamine are being used to tackle treatment-resistant depression, with one of its enantiomers (esketamine) approved as a nasal spray for this indication in the United States.
Kratom
A plant species (Mitragyna Speciosa) native to Southeast Asia has psychoactive, though not psychedelic properties. Advocates claim that it can be used to treat opiate addiction and other conditions. It is not presently on a Controlled Substances Act schedule but the U.S. Food and Drug Administration has undertaken regulatory actions against importers and sellers of kratom, and some states prohibit it.
L
Licensed Mental Health Professional
An adult who is licensed by a mental health board to provide mental health therapy/counseling has a minimum of a master's degree (graduate school) education and can be someone who has completed a doctorate (PhD or PsyD) in a psychology-related field. A mental health therapist has a graduate degree (or higher) in counseling, psychology, social work, or marriage and family therapy.
IN OREGON: Under current laws, licensed mental health therapists face challenges with concurrently acting as a therapist and becoming a licensed psilocybin facilitator. At a minimum, if a person is dual-licensed as a therapist and facilitator, they cannot administer psilocybin during the course of providing mental health therapy, and they cannot provide mental health therapy while acting as a facilitator.
Lion’s Mane
With roots in traditional Chinese medicine (TCM), Lion’s Mane mushroom is also known as Hericium erinaceus, yamabushitake, hedgehog mushroom, and houtou. Based on human and animal studies, this humble shroom is a powerful anti-inflammatory, antioxidant, and immunostimulant. Translation: It’s mega good for you. Your brain naturally slows down over time. The symptoms you associate with aging — like memory loss and lack of focus — are caused by factors like shrinking neurons and damaged brain cells. Studies show that lion’s mane mushroom can actually support your brain health by stimulating the creation of two important compounds: nerve growth factor (NGF) and brain-derived neurotrophic factor (BDNF). Lion’s mane can boost your focus, too. Reduced inflammation improves blood flow, which provides your brain with more oxygen. More oxygen in your brain means better brain performance, period. The antioxidants in lion’s mane also promote learning and memory, possibly by strengthening your brain cells and stimulating the growth of new neurons.
LSD (lysergic acid diethylamide)
A psychedelic compound first synthesized by Albert Hofmann in 1938. Hofmann accidentally ingested a small quantity of the drug while resynthesizing it five years after shelving it, and discovered its hallucinogenic properties. This marked the first intentional ingestion of LSD, with the day—April 19, 1943—now celebrated annually as Bicycle Day. LSD is colloquially known as acid. LSD was used to assist psychotherapy in the 1950s and 1960s, but studies conducted at the time lacked rigor. More recently, MAPS completed a Phase 2 double-blind placebo-controlled study of LSD-assisted psychotherapy for anxiety (n=12), with positive results
M
Magic Truffle
The psychoactive Sclerotia of psilocybin mushrooms. Sclerotia is a dense mass of hardened fungal mycelium which contains food reserves. They contain a lower dose of psilocybin than magic mushrooms, resulting in a short, yet impactful trip. Magic truffles may be purchased legally in the Netherlands.
Major Depressive Disorder (MDD)
Often referred to as ‘depression’. MDD is one of the most common mental health disorders in the United States and across the world. Where pervasive low mood persists for at least two weeks, a diagnosis may be made. Affecting over 165 million people annually, MDD is onset by a combination of genetic, environmental, and physiological factors. A particularly relevant clinical study examining the ability of psilocybin-assisted therapy to treat MDD was released in 2020 by the Center for Psychedelic and Consciousness Research at Johns Hopkins
MAPS (Multidisciplinary Association for Psychedelic Studies)
Founded by Rick Doblin in 1986, MAPS is a nonprofit seeking to raise awareness and understanding of psychedelics. MDMA has been the primary focus of MAPS in recent years, specifically in the treatment of PTSD. To this end, MAPS received FDA approval to initiate Phase 3 trials in 2016, before the Agency went on to designate MDMA as a breakthrough therapy for PTSD.
MDMA (3,4-methylenedioxymethamphetamine)
MDMA was first synthesized by pharmaceutical juggernaut Merck in 1912 but never came to market. Sixty years later, in the 1970s, Sasha Shulgin resynthesized it in his Bay Area home. This time, its empathogenic qualities (see empathogen above) were harnessed to augment psychotherapy, assisting in the building of trust between the therapist and the therapised. Despite the fact that the drug has been Schedule 1 in the United States since the late 1980s, MAPS (see above) has demonstrated its efficacy in the treatment of PTSD, landing MDMA a Breakthrough Therapy designation from the FDA.
Mescaline
A naturally-occurring psychedelic, found in the peyote and San Pedro cactus (among other cactus species). Arthur Heffter first isolated and identified the compound in 1897, and it was first synthesized by Ernst Späth in 1918. Writer and philosopher Aldous Huxley recounted his experience with mescaline in The Doors of Perception (1954).
Mexicana Galindoi
Psilocybe Galindoi is another one of the rare Mexicana mushroom strains that produce psilocybin-enriched sclerotia also referred to as “magic truffles” or “philosopher stones”. These magic truffles grow quite easily in nature, in fact, they are easier to produce than the actual mushrooms. In 2008 the Netherlands banned psilocybin mushrooms in the famous coffee shops, but not the magic truffles. These magic truffles are still shipped throughout Europe legally and grow kits are sold openly.
Mexicana Jalisco
Ps. Mexicana (Jalisco Mexico strain) is one of the rare mushrooms that produce psilocybin-enriched sclerotia also referred to as “magic truffles” or “philosopher stones”. The sclerotia are small nuggets that grow under the soil and are a survival mechanism for the fungi. If conditions get bad and the surrounding mycelia network gets damaged or dies, the sclerotia lies dormant for the conditions to be favorable again and then sends out new mycelium from the sclerotia to continue the organisms life cycle. In 2008 the Netherlands banned psilocybin mushrooms in the famous coffee shops, but not the magic truffles. These magic truffles are still shipped throughout Europe legally and grow kits are sold openly. Please note, the Jalisco strain is poor sclerotia producer but a good fruiter.
Microdosing
The ingestion of a sub-perceptual dose of a psychedelic (often psilocybin or LSD) with the aim of augmenting mental performance and/or mental health.
Mystical Experience Questionnaire
A self-reported measure, in the form of a survey, used by researchers to understand whether a participant had a mystical experience (e.g., after ingesting psychedelics in a trial). The conventional version, which has 43 items, was developed by Walter Pahnke and William Richards in the 1960s. A revised version, including 30 items, was validated in 2015 and is often used in contemporary research.
N
Neuroplasticity
Neuroplasticity is the brain’s ability to adapt, modify, and change structure through the growth and reorganization of neural networks in the organ. Psychedelics such as LSD, DMT, ketamine, and psilocybin have been found to promote neuroplasticity, one of the reasons why they may provide a novel means of treating mood and anxiety disorders.
New Drug Application (NDA)
The NDA is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the United States. The NDA should provide sufficient information to convince the FDA that the drug is safe and effective; that the labeling is appropriate; and that the methods of manufacture, and quality control, are adequate.
NMDA Receptor (NMDAR)
The N-Methyl-D-aspartic acid receptor (NMDAR) requires coactivation of glutamate and glycine as well sufficient neuronal excitation to remove the magnesium blocking the pore. Indeed, its activation is mechanistically complex. NMDARs play a significant role in memory, learning, and synaptic plasticity. The activity of this receptor is affected by many psychoactive drugs such as alcohol, PCP, and ketamine. Notably, NMDAR antagonists like ketamine, PCP, and NO are thought to have anesthetic properties through this mode of action.
Non-Ordinary State of Consciousness
Typically this refers to any “altered” state or perception of reality, which can be achieved through various means, from ingesting a substance with psychedelic properties to employing special breathwork (e.g. “holotropic”) techniques.
O
Observational Study
Observational studies or investigations are frequently used in the social sciences to understand relationships or associations in a target sample population where the independent variable is not under the control of the researcher. This method is typically employed when studying human psychology or behavior in a naturalistic environment, for example.
Open Field Test (OFT)
The open field test (OFT) is a preclinical behavioral test where rodents are placed in an open and novel environment. Since rodents are naturally exploratory animals, the amount of time they spend immobile with a preference for walls (thigmotaxis), is thought to correlate to greater levels of anxiety and stress.
Open Label
Open-label clinical trials are designed when both the researcher and the participant are aware of the treatment to be received (control/placebo or test drug in a two-arm clinical design). This type of trial design is converse to double-blind studies in which neither the researcher nor the participant is aware of the treatment to be received. It is notable that regardless of the trial design, the type of treatment to be received can still be randomized.
Orphan Drug Designation
A special status is granted to a drug or biological product under the Orphan Drug Act (ODA). In order to receive orphan designation, a drug must be intended for the treatment, prevention, or diagnosis of a rare disease or condition – one that affects less than 200,000 persons in the US or meets cost recovery provisions of the act (FDA).
P
PE (Penis Envy)
These mushrooms are characterized by their mutant penis-like appearance. They are typically thick, gnarly stemmed mushrooms with a bulbous cap that only sometimes separates from the stem, at least with the true genetics. We have seen tons of fables and stories of how this particular strain originated, but it is our opinion that no one really knows. If you look around you will see images of what people call penis envy.
Peyote
A plant psychedelic native to the Americas that contains psychedelic compounds, primarily mescaline. It is included in Schedule I of the Controlled Substances Act.
PF
PF Classic Professor Fanaticus Spores mushrooms and their spores are also some of the most sought-after psilocybe cubensis ever found. This psilocybe cubensis magic mushroom was first discovered on a farm growing in a pile of dung and straw as its mushroom substrate in Florida.
Phase I (Clinical Trial)
Phase I clinical trials are intended to establish initial safety in humans. The drug is given to a small number of healthy volunteers to test for possible side effects and determine what the safe dosing range is.
Phase II (Clinical Trial)
Phase II clinical trials are the first in which the drug is tested in a small group of patient volunteers with the disease it is meant to treat. Phase II studies assess the safety and efficacy of the drug across a range of doses. Due to the small number of patients involved, conclusions about overall efficacy cannot be drawn, however, Phase II trials provide guidance on how to optimally design larger Phase III trials to confirm the drug’s safety and efficacy.
Phase III (Clinical Trial)
Phase III trials, also known as pivotal trials, demonstrate a drug’s safety and efficacy in a large group of patients. Typically, at least two successful Phase III trials are required in order to provide sufficient evidence of efficacy. Given the large number of patients required, Phase III trials are most often multi-center, international trials.
Phase IV (Clinical Trial)
Following the approval of a drug by the FDA, post-marketing surveillance is conducted with the primary goal of monitoring long-term effects.
Phenethylamines
Compounds that act as central nervous system stimulants, and have psychedelic effects. Well-known phenethylamines include mescaline and MDMA. Alexander Shulgin pioneered synthetic work in phenethylamines, documenting his efforts (which resulted in drugs such as 2C-B) in his book PiHKAL, which stands for Phenethylamines I Have Known And Loved.
Placebo
In a clinical drug trial with multiple treatment arms, it is necessary to test the drug efficacy against a control. The control group will typically receive a placebo, which could be, for example, an intravenous injection of saline or a sugar pill in place of the drug. Indeed, placebos have no therapeutic value and thus, serve as a comparison to the test drug. See Active Placebo for more.
Post-Traumatic Stress Disorder (PTSD)
A mental disorder that may develop following exposure to a traumatic event. MAPS is working to achieve FDA approval for MDMA-assisted psychotherapy for PTSD (see MAPS).
Pre-Investigational New Drug (IND) Meeting
An opportunity for the sponsors of a drug to meet with the FDA prior to formally filing an IND application. Pre-IND meetings allow sponsors to incorporate FDA feedback into their drug development (FDA).
Preparation
The period of time when you may identify and/or discuss why you’re considering psilocybin, learn about the limitations and issues, determine what you want to heal or resolve from using psilocybin and create goals for your psilocybin experience if you decide to take it. NOTE: Preparation as part of Oregon Psilocybin Services is a different process geared toward preparing a consumer for taking part in OPS at a licensed facility (e.g. review of informed consent paperwork and rules/guidelines for the day of administration)
Psilocin (4-HO-DMT)
The metabolite of psilocybin (see below), produces psychedelic effects. A psychedelic substance that is found in many psychedelic mushrooms along with psilocybin. It is included in Schedule I of the Controlled Substances Act.
Psilocybin
A naturally-occurring psychedelic drug found in over 200 species of fungus. Psilocybin is a prodrug, which the body converts to psilocin. It is scheduled on Schedule I of the Controlled Substances Act, though a number of jurisdictions have decriminalized its possession and the State of Oregon has created the framework for a regulatory program for it.
Psychedelics
Drugs that cause sensory (audible and visual) or psychological hallucinatory effects.
Psychedelic-Assisted Therapy (PAT)
Psychedelic-Assisted Therapy (PAT) is a therapeutic practice led by a registered clinician that employs traditional “talk therapy” (psychotherapy) while the patient is administered a psychedelic. It is thought that psychedelics can increase patient suggestibility and allow them to be more receptive to talk therapy, which can be reflected in everlasting changes in both attitudes and beliefs. PAT has been demonstrated to be effective for a range of mental health indications such as substance use disorder (SUD) and major depressive disorder (MDD).
Psychedelic Practitioner
A person whose job or license is to administer a psychedelic substance like psilocybin (like an Oregon Psilocybin facilitator, an entheogenic practitioner, or a guide/sitter)
Psychedelic Retreats
Events to which individuals travel to consume psychedelics, generally for medicinal, spiritual, and/or ceremonial purposes, and also generally under the supervision of religious leaders or trained professionals.
R
Randomized Control Trial (RCT)
A randomized control trial is a type of clinical or basic science investigation that randomly assigns whether the participant is to receive a treatment or placebo/control. Therefore, it is thought that in a clinical the only observed differences between the two clinical arms must be attributed to the efficacy of the treatment intervention.
Reishi
Reishi mushroom is a fungus that holds an important place in the traditional medical systems of China, Japan, Korea, and other Asian countries for its health-promoting effects. It is used as an immunostimulant by patients with HIV and cancer. The active constituents include both beta-glucan polysaccharides and triterpenes. Extracts of reishi were shown to have immunomodulatory, renoprotective, anti-inflammatory, and hepatoprotective properties both in vitro and in vivo. Clinical studies indicate its benefits in improving lower urinary tract symptoms (LUTS) in men, in exerting mild anti-diabetic effects, and in improving Dyslipidemia.
S
Salvia
Salvia divinorum is a plant species that is a relative of sage which can be found growing in the wild in areas of Mexico. Mazatec shamans have used the leaves of the plant in healing rituals and for medicinal purposes. The primary psychoactive in Salvia is salvinorin A, and ingestion of the plant results in a short, potent, psychedelic experience.
Sclerotia
See magic truffle.
Serotonin
Serotonin is a neurotransmitter released by axon terminals that has widespread regulatory function in the brain. The molecule contributes to reward, mood states, and numerous physiological processes. It is produced in the raphe nucleus of the brainstem. It is through the serotonin-binding receptor (5-HT2) that the hallucinogenic effects are produced with classic psychedelics LSD, mescaline, and psilocin.
Set and Setting
Refers to the participant’s mindset (‘set’) and physical and social environment (‘setting’) during a psychedelic experience. Supportive set and setting are thought to be central to a positive psychedelic experience.
Spiritual Practice
A spiritual practice or spiritual discipline (often including spiritual exercises) is the regular or full-time performance of actions and activities undertaken for the purpose of inducing spiritual experiences and cultivating spiritual development. Pata-us.org defines spiritual practice as the connection of yourself to something that is greater than the self. Examples include religious deities, the universe, nature, etc. Spiritual consciousness stems from the possibility of structuring consciousness, through meditation, contemplation, and other means, so that it focuses on one- ness, transcendent states, and ultimate concerns.
Spore Kits
Spore kits allow individuals to cultivate mushrooms. In many cases, they do not contain controlled substances but can be used to cultivate mushrooms containing controlled substances such as psilocybin. Their legal status is complicated, and several U.S. states have outlawed spore kits capable of producing controlled substances.
SSRI (Selective Serotonin Reuptake Inhibitor)
A class of drugs that represent the most widely prescribed antidepressants in many societies. They are typically prescribed to individuals suffering major depressive disorder, anxiety disorders, and related mental health indications. Serotonin is a neurotransmitter, meaning it carries signals between nerve cells in the brain. Usually, when serotonin has carried a message, it is then reabsorbed by the nerve cells (reuptake). SSRIs, however, inhibit this reuptake, resulting in greater availability of serotonin in the brain.
Substrate
An underlying substance or layer of organic media used in the cultivation of psilocybin mushrooms.
T
Tail Suspension Test (TST)
The tail suspension test (TST) is similar in concept to the forced swim task (FST) but has a much greater sensitivity. In this preclinical behavioral test, rodents are suspended by the tail and are observed for the duration spent mobile versus immobile. Animals that spend more time immobile are thought to have greater apathy and depressed mood. Acute administration of antidepressants has been shown to reduce the amount of time the animal spends immobile.
Treatment-Emergent Serious Adverse Event (TESAE)
A term used in U.S. Food and Drug Administration drug trials, including for psychedelic drugs, in reference to any event not present prior to the initiation of treatments, or any event already present that worsens in either intensity or frequency following exposure to the treatments.
Treatment-Resistant Depression (TRD)
A condition affecting those with Major Depressive Disorder (MDD, see above) who show little positive response to a course of an appropriate antidepressant. The definition and measurement of an ‘inadequate response’ varies, however. Compass Pathways is conducting clinical trials to investigate the efficacy of psilocybin therapy for TRD.
Tripsitter or Guide
IN OREGON: These individuals are those who are available to be with you during your psilocybin session. We do not consider licensed mental health professionals to be sitters or guides if they are providing professional services.
Tryptamines
A family of compounds that includes the neurotransmitter serotonin (see SSRIs) and psychedelics such as psilocybin, LSD, and DMT.
Turkey Tail
Did you know that the colorful mushroom growing on that fallen tree trunk in your backyard may have immune-boosting properties? Now, you won’t want to go foraging for any random mushrooms you find in your backyard, but you may be curious to find that some of them have incredible health benefits and uses. Medicinal mushrooms have been used in Eastern and folk medicine for thousands of years, but recent research has shown that out of the vast scope of medicinal mushrooms out there, turkey tail mushrooms are one of the most potent varieties. Turkey tail mushrooms look like their namesake: they are flat, multicolored discs that grow on trees and logs throughout North America. Currently, the FDA is conducting clinical trials on this medicinal mushroom’s applications for patients undergoing cancer treatment such as chemotherapy. Interestingly, this is an application already approved in many Asian countries, such as Japan and China. While the findings of the FDA’s trial are to be determined, there’s ample evidence that turkey tail mushrooms provide a range of health benefits.
Source:
Psychedelicalpha.com
Harrisbricken.com
PATA-us.org
