Investigation of Psychedelic Effects in... — Clinical Trial Details

Randomized, triple-masked, within-subject laboratory study in healthy adult volunteers assessing subjective effects of multiple psychoactive drugs compared with placebo across up to six experimental sessions.

Screening includes medical and psychiatric evaluation, ECG, and routine blood and urine tests. Participants complete two preparation sessions (total 4 hours) prior to the first experimental session and follow-up debrief visits after each dosing session.

Participants

Ages

25 – 55

Sexes

Male & Female

BMI

18 - 34

Psychosis History

Excluded

Inclusion Criteria

Be 25 to 55 years old
BMI between 18 and 34 kg/m2
Agree to consume approximately the same amount of caffeine-containing beverage that they usually consume on mornings of session days; if they do not usually consume caffeine, must agree not to on session days
Agree to refrain from using any psychoactive drugs, including alcoholic beverages, within 24 hours of each drug administration (exceptions: daily caffeine and nicotine)
Be healthy and psychologically stable as determined by screening (medical interview, questionnaire, physical exam, ECG, routine blood and urinalysis)
Agree not to take PRN prescription medications on the mornings of sessions unless deemed appropriate by study team

Exclusion Criteria

Women who are pregnant or nursing; women of child-bearing potential who are sexually active and not using effective birth control
Cardiovascular conditions (coronary artery disease, stroke, angina, uncontrolled hypertension), clinically significant ECG abnormality, or other condition that would put participant at especially high risk
Epilepsy with history of seizures
Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycaemia
Regular use of medications with primary centrally acting serotonergic effects or MAO inhibitors (sessions postponed until at least 5 half-lives after last dose for intermittent/PRN use)
Use of nonprescription medications, supplements, or herbal supplements except when approved by investigators (exceptions evaluated case-by-case)
History of DSM-5 moderate or severe substance use disorder (excluding tobacco) with evidence of prior loss of control
Active suicidal ideation and/or behaviour at time of screening
Psychiatric disorder that would in the opinion of study team put participant at especially high risk
First-degree relative meeting DSM-5 criteria for a Schizophrenia Spectrum or Other Psychotic Disorder, Bipolar I or Bipolar II disorder (with specified exceptions)
Enrolled in another clinical trial or received any research drug within 30 days prior to dosing
Known allergy or prior adverse reaction to any study drugs judged to increase risk
Known allergy or intolerance to nitroglycerin
Concomitant use of CYP2C9 or CYP3A4 inhibitors

Company

Product

Legal

Investigation of Psychedelic Effects in Psychoactive Substances

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Study Arms & Interventions

Placebo

Interventions

Psilocybin

Interventions

Other psychoactive

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators