Clinical TrialHealthy VolunteersMDMAPsilocybinPlaceboCompleted

Acute Effects of 2C-B Compared With MDMA and Psilocybin in Healthy Subjects (2C-B)

This RCT (n=24) does a direct comparison, the first one in a double-blind trial, of MDMA, psilocybin, and 2C-B (10/20/30 mg) plus placebo in a six-period crossover in healthy subjects.

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

Detailed Description

Randomised, triple-masked, placebo-controlled, six-period cross-over study in healthy volunteers comparing single oral doses of 2C-B (10, 20, 30 mg), MDMA (125 mg), psilocybin (25 mg) and placebo.

Aims are to characterise acute subjective, physiological and endocrine profiles and to compare empathogenic and classic psychedelic effects within the same subjects for basic science purposes.

Subjective effects peak 1–2 hours and are reported to last about 5 hours; outcomes include subjective ratings, vitals and endocrine measures.

Study Protocol

Preparation

sessions

Dosing

6 sessions
300 min each

Integration

sessions

Study Arms & Interventions

2C-B 10 mg

experimental

Low dose 2C-B (10 mg) single-dose session.

Interventions

  • Compound10 mg
    via Oral• single dose• 1 doses total

    4-bromo-2,5-dimethoxyphenethylamine (2C-B) 10 mg

2C-B 20 mg

experimental

Medium dose 2C-B (20 mg) single-dose session.

Interventions

  • Compound20 mg
    via Oral• single dose• 1 doses total

    4-bromo-2,5-dimethoxyphenethylamine (2C-B) 20 mg

2C-B 30 mg

experimental

High dose 2C-B (30 mg) single-dose session.

Interventions

  • Compound30 mg
    via Oral• single dose• 1 doses total

    4-bromo-2,5-dimethoxyphenethylamine (2C-B) 30 mg

MDMA 125 mg

active comparator

Single oral dose MDMA (125 mg).

Interventions

  • MDMA125 mg
    via Oral• single dose• 1 doses total

    125 mg oral MDMA

Psilocybin 25 mg

active comparator

Single oral dose psilocybin (25 mg).

Interventions

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total

    25 mg oral psilocybin

Placebo

inactive

Placebo (mannitol) control.

Interventions

  • Placebo
    via Oral• single dose• 1 doses total

    Placebo (mannitol)

Participants

Ages
25 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Age between 25 and 65 years.
  • Sufficient understanding of the German language.
  • Understanding the procedures and the risks that are associated with the study.
  • Participants must be willing to adhere to the protocol and sign the consent form.
  • Participants must be willing to refrain from taking illicit psychoactive substances during the study.
  • Participants must be willing to drink only alcohol-free liquids and no coffee, black or green tea, or energy drink after midnight of the evening before the study session, as well as during the study day.
  • Participants must be willing not to drive a traffic vehicle or to operate machines within 48 h after substance administration.
  • Women of childbearing potential must have a negative pregnancy test at the beginning of the study. Pregnancy tests are repeated before each study session.
  • Women of childbearing potential must be willing to use double-barrier birth control.
  • Body mass index between 18-29kg/m2

Exclusion Criteria

  • Exclusion Criteria:
  • Chronic or acute medical condition, including a history of seizures.
  • Current or previous major psychiatric disorder (e.g. psychotic disorders, mania / hypomania, anxiety disorders).
  • Psychotic or bipolar disorder in first-degree relatives, not including psychotic disorders secondary to an apparent medical reason, e.g. brain injury, dementia, or lesions of the brain.
  • Hypertension (SBP>140/90 mmHg) or hypotension (SBP<85 mmHg)
  • Ilicit substance use (with the exception of cannabis) more than 20 times or any time within the previous two months
  • Pregnant or nursing women.
  • Participation in another clinical trial (currently or within the last 30 days).
  • Use of medications that may interfere with the effects of the study medications (any psychiatric medications and any medication with known to interact with the study substances).
  • Tobacco smoking (>10 cigarettes/day).
  • Consumption of alcoholic drinks (>20 drinks / week).
  • Body weight < 45 kg.

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedtriple Blind
  • Target Enrollment24 participants
  • Timeline
    Start: 2022-12-31
    End: 2024-03-31
  • Compounds
    MDMAPsilocybinPlacebo
  • Topic
    Healthy Volunteers

Locations

University Hospital Basel — Basel, Switzerland

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