Actively Recruiting

Phase 1
Age: 25Years - 55Years
All Genders
Healthy Volunteers
NCT06772753

Investigation of Psychedelic Effects in Psychoactive Substances

Led by Johns Hopkins University · Updated on 2026-02-23

50

Participants Needed

1

Research Sites

147 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Investigation of Psychedelic Effects in Psychoactive Substances

Who Can Participate

Age: 25Years - 55Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Be 25 to 55 years old
  • Body mass index (BMI) between 18 and 34 kg/m2
  • Agree to consume about the same amount of caffeine on session mornings as usual, or avoid caffeine if not usually consumed
  • Agree to avoid psychoactive drugs, including alcohol, for 24 hours before each drug session, except caffeine and nicotine
  • Be healthy and psychologically stable based on medical history, physical exam, ECG, and lab tests
  • Agree not to take as-needed prescription medications on session mornings unless approved by the study team
Not Eligible

You will not qualify if you...

  • Women who are pregnant, nursing, or of child-bearing potential not using effective birth control
  • Cardiovascular conditions like coronary artery disease, stroke, angina, uncontrolled hypertension, or significant ECG abnormalities
  • History of epilepsy or seizures
  • Insulin-dependent diabetes or history of hypoglycemia if taking oral diabetes medication
  • Regular use of medications affecting serotonin or MAO inhibitors; no sessions until 5 half-lives after last dose if used as needed
  • Use of nonprescription or herbal supplements without study approval, except acetaminophen, NSAIDs, vitamins, and minerals
  • History of moderate or severe substance use disorder with loss of control
  • Active suicidal thoughts or behavior at screening
  • Psychiatric disorders posing high risk for adverse effects
  • First-degree relatives with schizophrenia spectrum, bipolar I or II disorders
  • Participation in another clinical trial or drug use in research within 30 days prior to dosing
  • Known allergy or adverse reaction to study drugs or nitroglycerin
  • Use of CYP2C9 and CYP3A4 inhibitors concurrently

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Johns Hopkins Center for Psychedelic and Consciousness Research

Baltimore, Maryland, United States, 21218

Actively Recruiting

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Research Team

Z

Zach Daily

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

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