Clinical TrialHealthy VolunteersMDMAPlaceboCompleted

Effects of Stimulants on Behavioral and Neural Markers of Social Motivation, Ability, and Neural Markers of Social Function (MASM)

Randomised, triple-blind, crossover early-phase study (n=43) comparing single oral MDMA 125 mg, methamphetamine 20 mg, and placebo in healthy volunteers to assess social motivation, social ability, and neural indices of social function.

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

Detailed Description

Randomised, triple-blind, three-period crossover in healthy volunteers comparing single oral doses of MDMA (125 mg), methamphetamine (20 mg), and placebo with 5 days between sessions; primary purpose basic science.

Outcomes assess behavioural measures of social motivation and ability and neural indices of social function; enrolment reported as 43 actual participants.

Study Protocol

Preparation

sessions

Dosing

3 sessions

Integration

sessions

Study Arms & Interventions

Crossover drug

experimental

Three-period crossover: placebo, MDMA 125 mg, and methamphetamine 20 mg (single doses; order randomised).

Interventions

  • MDMA125 mg
    via Oral• single dose

    Single oral 125 mg MDMA; one session per condition, 5 days between sessions.

  • Compound20 mg
    via Oral• single dose

    Single oral 20 mg methamphetamine (MA).

  • Placebo0 mg
    via Oral• single dose

    Placebo oral tablet containing lactose.

Participants

Ages
18 – 40
Sexes
Male & Female

Inclusion Criteria

  • BMI between 19 and 30 (no one under 130 lbs)
  • Smokers smoking less than 25 cigarettes per week
  • Have used ecstasy no more than 40 times with no adverse responses.
  • Age 18–40; able to consent.

Exclusion Criteria

  • High blood pressure
  • Any medical condition requiring regular medication
  • Individuals with a current (within the last year) DSM-IV Axis 1 diagnosis
  • Individuals with a history of dependence on stimulant drugs
  • Women who are pregnant or trying to become pregnant

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedtriple Blind
  • Target Enrollment43 participants
  • Timeline
    Start: 2022-05-01
    End: 2023-07-01
  • Compounds
    MDMAPlacebo
  • Topic
    Healthy Volunteers

Locations

University of Chicago — Chicago, Illinois, United States

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