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

MDMA

Brief Summary

To study the effects of MDMA, compared to a prototypical stimulant, on social motivation, social ability, and neural indices of social function in healthy volunteers

Intervention / Treatment

  • MDMA (DRUG)
    Participants will be given 125 mg of MDMA.
  • Methamphetamine (DRUG)
    Participants will be given 20 mg of MA.
  • Placebo oral tablet (DRUG)
    Participants will be given a placebo capsule that will only contain lactose.

Condition or Disease

  • Stimulant Use
  • MDMA ('Ecstasy')
  • Social Behavior
  • Motivation

Phase

  • Early Phase 1

    • Study Design

    Study type: INTERVENTIONAL
    Status: Recruiting
    Study results: No Results Available
    Age: 18 Years to 40 Years
    Enrollment: 36 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Basic Science

    Masking

    TRIPLE:
    • Participant
    • Care Provider
    • Investigator

    Clinical Trial Dates

    Start date: May 11, 2022 ACTUAL
    Primary Completion: Jul 01, 2023 ESTIMATED
    Completion Date: Jul 01, 2023 ESTIMATED
    Study First Posted: May 18, 2022 ACTUAL
    Last Updated: Oct 20, 2022

    Sponsors / Collaborators

    Lead Sponsor: University of Chicago
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Chicago, Illinois, USA

    Participant Groups

    • Participants first receive placebo at their first session in the laboratory. Then will return to the laboratory 5 days later and will receive 125 mg MDMA. Finally, 5 days later will return to the laboratory and will receive 20 mg of MA.

    • Participants first receive 125 mg of MDMA at their first session in the laboratory. Then will return to the laboratory 5 days later and will receive placebo. Finally, 5 days later will return to the laboratory and will receive 20 mg of MA.

    • Participants first receive 20 mg of MA at their first session in the laboratory. Then will return to the laboratory 5 days later and will receive placebo. Finally, 5 days later will return to the laboratory and will receive 125 mg of MDMA.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 40
    Age Groups: Adult
    Healthy Volunteers: Yes

    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.

    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

    This clinical trial is recruiting

    Are you interested in participating in this trial or others? We'd love to help.

    Primary Outcomes

    • The POMS measures individuals' mood states. This is a validated scale to measure positive and negative mood states. The POMS contains 30 items and assesses six identified mood factors: Tension-Anxiety, Depression-Ejection, Anger- Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. Scoring of the instrument provides a global score of 0 to 120 or individual domain scores. Lower scores indicate better mood state. The POMS brief form is a simple self-rating instrument.

    More Details

    NCT Number: NCT05379959
    Acronym: MASM
    Other IDs: IRB21-1568
    Study URL: https://clinicaltrials.gov/study/NCT05379959
    Last updated: Sep 29, 2023