scientific investigation of healthy subjects healthy
Conditions
Interventions
None listed
Sponsors
Universiteit Leiden
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 18-40 years old; Physically and mentally healthy; Right-handed; Normal, or corrected-to-normal vision; Good command of the English language; Prior experience with a hallucinogenic drug (i.e., the subject must have taken a serotonergic hallucinogen, such as psilocybin, LSD, DMT or ayahuasca at least 5 times) without an adverse event; Capable of giving informed consent; Providing informed consent prior to the study as documented by signature; Willing to refrain from drinking alcohol up within 24 hours before each experimental session, willing to refrain from caffeine within 3 hours before each experimental session, and willing to refrain from nicotine during each experimental session; Willing to refrain from consuming psychoactive substances, except caffeine, alcohol and nicotine, two weeks before enrolling in the study and for the remainder of the study; Have a family member or friend (the responsible other) with prior experience with a hallucinogenic drug, who they can rely on for support in case they encounter challenging experiences or after-effects during or following the experimental session. Agree to refrain from operating a vehicle on the evening of the experimental session; Agree to eat only a light snack within 4 hours before taking part in each experimental session.
Exclusion criteria
Exclusion criteria: Have a current psychiatric diagnosis, a lifetime history of bipolar affective disorder type 1, or a history of a primary psychotic disorder assessed via the Mini International Neuropsychiatric Interview (MINI); Have one or several current neurological disease(s) or long-term adverse consequences resulting from a previous neurological disease; Have one or more immediate family members with a current or previously diagnosed bipolar affective disorder type 1 or primary psychotic disorder; Any subject presenting suicide risk, as determined through the screening and responses to C-SSRS will be excluded. Exclusion criteria include the following: History of a suicide attempt within the last 10 years Suicidal ideation (a score of 1 or greater) within the past year; Have a medically significant condition which renders them unsuitable for the study (e.g., diabetes, severe cardiovascular disease, hepatic or renal failure etc.); Weigh less than 45 kg; Significant history of head trauma, premature birth, learning disabilities, neurological or psychiatric illness; Are not able to give adequate informed consent; Heart arrhythmia or hypertension; Use of antidepressants or psychotropic medication; Are pregnant, nursing, or can become pregnant and not willing to practice an effective means of birth control; Have no prior experience with a serotonergic hallucinogenic drug (e.g., LSD, magic mushrooms or truffles, DMT, ayahuasca); Have previously experienced an adverse response to a serotonergic hallucinogenic drug; Have any current moderate or severe alcohol use disorder or substance use disorder based the results of the MINI; Smoking more than five cigarettes a day - to avoid nicotine withdrawal effects during the experimental session; Use of any substance with activity on the serotonergic system, including antidepressants, lithium, 5-HTP, and St. John*s Wort, is prohibited for 5 half-lives of the medication or active metabolite prior to the experimental Session.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Behavioural measures: effects of psilocybin-containing truffles on reaction times, recognition memory, attribution object, valence assessment ("positive*, *negative*). | — |
Secondary
| Measure | Time frame |
|---|---|
| Psychometric measures: subjective drug effects as regressors for behavioral and data. | — |
Countries
Netherlands
Outcome results
None listed