Actively Recruiting

Phase 1
Age: 25Years - 55Years
All Genders
Healthy Volunteers
ID06772753

Investigation of Psychedelic Effects in Psychoactive Substances

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

50

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying whether various psychoactive substances can cause experiences similar to those produced by classic psychedelics. This double-blind, placebo-controlled study involves healthy adult volunteers aged 25 to 55 and aims to understand the subjective effects of these substances. The study is sponsored by Johns Hopkins University and includes a randomized design with both participants and staff unaware of the drug given during sessions. Participants may receive one of several psychoactive drugs, including psilocybin, ketamine, dextromethorphan (DXM), dimethyltryptamine (DMT), methylenedioxymethamphetamine (MDMA), delta-9-tetrahydrocannabinol (THC), or an inactive placebo. Doses are oral and limited to amounts safely administered previously in laboratory settings. The study includes up to six experimental drug sessions per participant, preceded by two preparation sessions totaling four hours. After each drug session, participants attend follow-up visits to discuss their experiences. During the study, participants undergo medical and psychiatric screening with blood tests, physical exams, interviews, and questionnaires. Researchers assess the mystical effects of the substances using the Mystical Experience Questionnaire and evaluate drug effects with the Drug Effects Questionnaire at weeks two and seven. The study monitors participant responses closely and continues until December 2027, with healthy volunteers contributing data on the psychedelic-like effects of these substances.

CONDITIONS

Brief 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 between 25 and 55 years old
  • Have a 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 you normally do not consume it
  • 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 and psychiatric screening
  • 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 sexually active without effective birth control
  • Cardiovascular conditions such as coronary artery disease, stroke, angina, uncontrolled hypertension, or significant ECG abnormalities
  • History of epilepsy or seizures
  • Insulin-dependent diabetes or history of hypoglycemia if using oral hypoglycemic agents
  • Regular use of medications affecting serotonin neurons or monoamine oxidase (MAO) inhibitors
  • Use of nonprescription, nutritional, or herbal supplements unless approved by investigators
  • History of moderate or severe substance use disorder with loss of control
  • Active suicidal thoughts or behavior at screening
  • Psychiatric disorders posing high risk as judged by the study team
  • First-degree relative with schizophrenia spectrum, bipolar I or II disorder, or related psychotic disorders
  • Participation in another clinical trial or drug use in research within 30 days prior to dosing
  • Known allergies or adverse reactions 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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Single day per drug session

Participants receive a single oral dose of placebo or one of several psychoactive substances during experimental sessions conducted in a laboratory setting.

1 to multiple in-person drug sessions depending on assigned substances

Follow-up

Duration - 7 weeks

Participants complete questionnaires assessing their experiences with the substances at 2 and 7 weeks after dosing.

2 follow-up visits for questionnaire assessments

Trial Site Locations

Total: 1 location

1

Johns Hopkins Center for Psychedelic and Consciousness Research

Baltimore, Maryland, United States, 21218

Actively Recruiting

Loading map...

Research Team

Z

Zach Daily

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Dose-response study of N,N-dimethyltryptamine in humans. II. Subjective effects and preliminary results of a new rating scale.

R J Strassman, C R Qualls, E H Uhlenhuth...

https://pubmed.ncbi.nlm.nih.gov/8297217

Phenomenology and therapeutic potential of patient experiences during oral esketamine treatment for treatment-resistant depression: an interpretative phenomenological study.

Joost J Breeksema, Alistair Niemeijer, Bouwe Kuin...

https://pubmed.ncbi.nlm.nih.gov/37222753

Double-blind comparison of the two hallucinogens psilocybin and dextromethorphan: similarities and differences in subjective experiences.

Theresa M Carbonaro, Matthew W Johnson, Ethan Hurwitz...

https://pubmed.ncbi.nlm.nih.gov/29116367