Investigation of Psychedelic Effects in Psychoactive Substances

This triple-blind, placebo-controlled, within-subjects trial (n=50) will investigate whether various psychoactive substances can produce experiences similar to classic psychedelics. Participants may receive psilocybin, ketamine, dextromethorphan (DXM), dimethyltryptamine (DMT), methylenedioxymethamphetamine (MDMA), tetrahydrocannabinol (THC), or a placebo across up to six experimental sessions.

Conducted by Johns Hopkins University, this Phase I study involves extensive screening, including medical and psychiatric evaluations. Participants will undergo two preparatory sessions before drug administration and follow-up visits after each session to discuss their experiences. The primary outcome measure is the Mystical Experience Questionnaire (MEQ-30), which assesses the intensity of psychedelic-like experiences. Secondary outcomes include the Drug Effects Questionnaire (DEQ), evaluating subjective drug effects. The study began in February 2025 and is expected to be completed by December 2027.

Trial Details

The aim of this double-blind, placebo-controlled, within-subjects study is to determine whether other psychoactive substances can produce experiences akin to those seen with classic psychedelics. Screening involves a medical and psychiatric examination, including blood draw, history and physical, interviews, and questionnaires. Eligible participants will then be asked to complete up to 6 experimental drug administration session during which the participants will potentially receive and report on the subjective effects of 6 different psychoactive substances or inactive placebo. Drug assignment for some sessions will be randomized (like flipping a count or rolling a pair of dice), and both participants and study staff will be blind to the drug condition on any given day. Participants will also complete 2 preparation sessions (4 hours total) before the first experimental session, and follow-up visits after each session to discuss and debrief on the participants subjective experience.

Trial Number NCT06772753

Data attribution

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