Investigation of Psychedelic Effects in Psychoactive Substances

Summary

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.

Conditions

• Psychedelic Effects in Healthy Volunteers

Interventions

DRUG

Placebo

inactive substance

DRUG

Psilocybin

active comparator for psychedelic effects

DRUG

Ketamine

psychoactive substance

DRUG

Dextromethorphan (DXM)

psychoactive substance

DRUG

Dimethyltryptamine (DMT)

psychoactive substance

DRUG

Methylenedioxymethamphetamine (MDMA)

psychoactive substance

DRUG

Tetrahydrocannabinol (THC)

psychoactive substance

Sponsors & Collaborators

• Johns Hopkins University

  lead OTHER

Principal Investigators

• Frederick Barrett, Ph.D. · Johns Hopkins University

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-02-05

Primary Completion

2027-06-30

Completion

2027-12-31

FDA Drug

Yes

Countries

• United States

Study Locations