Investigation of Psychedelic Effects in Psychoactive Substances

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT06772753
Phase
PHASE1
Status
Recruiting
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Conditions

  • Psychedelic Effects in Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
25 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Placebo — DRUG
    inactive substance
  • Psilocybin — DRUG
    active comparator for psychedelic effects
  • Ketamine — DRUG
    psychoactive substance
  • Dextromethorphan (DXM) — DRUG
    psychoactive substance
  • Dimethyltryptamine (DMT) — DRUG
    psychoactive substance
  • Methylenedioxymethamphetamine (MDMA) — DRUG
    psychoactive substance
  • Tetrahydrocannabinol (THC) — DRUG
    psychoactive substance

Study 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.

Key Dates

Start date
Feb 5, 2025
Status verified
Feb 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Placebo Comparator: Placebo
    Participants may receive an inactive placebo during any one of the experimental sessions.
  • Active Comparator: Psilocybin
    Participants may receive varying oral psychoactive doses of psilocybin (4-phosphoryloxy-N,N-dimethyltryptamine)
  • Experimental: Other psychoactive drugs
    Participants may receive varying oral psychoactive doses of ketamine, dextromethorphan (DXM), N,N-dimethyltryptamine (DMT), 3,4-methylenedioxymethamphetamine (MDMA), or delta-9-tetrahydrocannabinol (THC). All dose levels will be limited to doses that have been safely administered within a single day in a laboratory context in the past.

Primary Outcome Measure

Mystical Experience Questionnaire (MEQ-30) [ Time Frame: Week 2, Week 7 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins Center for Psychedelic and Consciousness ResearchBaltimoreMaryland21218
Zach Daily
[email protected]
410-550-2533
Frederick Barrett, PhD
[email protected]
410-550-9777
Frederick S. Barrett, PhD (PRINCIPAL_INVESTIGATOR)
Ryan Vandrey, PhD (SUB_INVESTIGATOR)
David Wolinsky, MD (SUB_INVESTIGATOR)

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By research site
Johns Hopkins Center for Psychedelic and Consciousness Research· Baltimore, MD

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