Clinical TrialHealthy VolunteersPlaceboPsilocybinKetaminePlaceboDMTMDMAPlaceboRecruiting

Investigation of Psychedelic Effects in Psychoactive Substances

Triple-blind, placebo-controlled, within-subjects study (n=50) testing whether various psychoactive substances (psilocybin, ketamine, DXM, DMT, MDMA, THC) produce experiences similar to classic psychedelics across up to six single-dose sessions.

Target Enrollment
50 participants
Study Type
Phase I interventional
Design
Randomized, triple Blind

Detailed Description

Randomized, triple-masked, within-subject laboratory study in healthy adult volunteers assessing subjective effects of multiple psychoactive drugs compared with placebo across up to six experimental sessions.

Screening includes medical and psychiatric evaluation, ECG, and routine blood and urine tests. Participants complete two preparation sessions (total 4 hours) prior to the first experimental session and follow-up debrief visits after each dosing session.

Study Protocol

Preparation

2 sessions
240 min each

Dosing

6 sessions

Integration

6 sessions

Study Arms & Interventions

Placebo

inactive

Inactive placebo that may be administered in any experimental session.

Interventions

  • Placebo
    • single dose

    Inactive placebo comparator; may appear in any session.

Psilocybin

active comparator

Oral psilocybin at varying experimental doses as an active comparator for psychedelic effects.

Interventions

  • Psilocybin
    • single dose

    Varying oral psychoactive doses; specific dosing per protocol.

Other psychoactive

experimental

Other psychoactive substances (ketamine, DXM, DMT, MDMA, THC) tested for psychedelic-like subjective effects.

Interventions

  • Ketamine
    • single dose

    Varying laboratory-safe single doses.

  • Placebo
    • single dose

    Dextromethorphan (DXM) — encoded as non-listed compound with name in notes.

  • DMT
    • single dose

    N,N-dimethyltryptamine (DMT) single-dose sessions.

  • MDMA
    • single dose

    MDMA single-dose sessions.

  • Placebo
    • single dose

    Delta-9-tetrahydrocannabinol (THC) — encoded as non-listed compound with name in notes.

Participants

Ages
25 – 55
Sexes
Male & Female

Inclusion Criteria

  • Be 25 to 55 years old
  • BMI between 18 and 34 kg/m2
  • Agree to consume approximately the same amount of caffeine-containing beverage that they usually consume on mornings of session days; if they do not usually consume caffeine, must agree not to on session days
  • Agree to refrain from using any psychoactive drugs, including alcoholic beverages, within 24 hours of each drug administration (exceptions: daily caffeine and nicotine)
  • Be healthy and psychologically stable as determined by screening (medical interview, questionnaire, physical exam, ECG, routine blood and urinalysis)
  • Agree not to take PRN prescription medications on the mornings of sessions unless deemed appropriate by study team

Exclusion Criteria

  • Women who are pregnant or nursing; women of child-bearing potential who are sexually active and not using effective birth control
  • Cardiovascular conditions (coronary artery disease, stroke, angina, uncontrolled hypertension), clinically significant ECG abnormality, or other condition that would put participant at especially high risk
  • Epilepsy with history of seizures
  • Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycaemia
  • Regular use of medications with primary centrally acting serotonergic effects or MAO inhibitors (sessions postponed until at least 5 half-lives after last dose for intermittent/PRN use)
  • Use of nonprescription medications, supplements, or herbal supplements except when approved by investigators (exceptions evaluated case-by-case)
  • History of DSM-5 moderate or severe substance use disorder (excluding tobacco) with evidence of prior loss of control
  • Active suicidal ideation and/or behaviour at time of screening
  • Psychiatric disorder that would in the opinion of study team put participant at especially high risk
  • First-degree relative meeting DSM-5 criteria for a Schizophrenia Spectrum or Other Psychotic Disorder, Bipolar I or Bipolar II disorder (with specified exceptions)
  • Enrolled in another clinical trial or received any research drug within 30 days prior to dosing
  • Known allergy or prior adverse reaction to any study drugs judged to increase risk
  • Known allergy or intolerance to nitroglycerin
  • Concomitant use of CYP2C9 or CYP3A4 inhibitors

Study Details

Locations

Johns Hopkins Center for Psychedelic and Consciousness Research — Baltimore, Maryland, United States

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