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

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05379959
Acronym
MASM
Enrollment
43
Registered
2022-05-18
Start date
2022-05-11
Completion date
2023-10-24
Last updated
2024-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

Interventions

DRUGplacebo oral tablet

Participants will be given a placebo capsule that will only contain lactose.

DRUGMDMA

Participants will be given 125 mg of MDMA.

Participants will be given 20 mg of MA.

Sponsors

University of Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Profile of Mood StatesTime Frame: Baseline-72 hours after completion of the sessionsThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026