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

Early Phase 1

Completed

• Conditions: Social Behavior; Motivation; Stimulant Use; MDMA ('Ecstasy')
• Interventions: Drug: MDMA; Drug: Methamphetamine; Drug: placebo oral tablet

• Registration Number: NCT05379959
• Lead Sponsor: University of Chicago

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-11
• Study First Submitted: 2022-05-13
• Study First Submitted QC: 2022-05-13
• Study First Posted: 2022-05-18
• Primary Completion: 2022-10-24
• Study Completion: 2023-10-24
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-23
• Last Update Posted: 2024-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental: MDMA Then Placebo Then Methampetamine	MDMA	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.
Experimental: Placebo Then MDMA Then Methamphetamine	placebo oral tablet	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.
Experimental: MDMA Then Placebo Then Methampetamine	placebo oral tablet	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.
Experimental: Methampetamine Then Placebo Then MDMA	MDMA	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.
Experimental: Methampetamine Then Placebo Then MDMA	placebo oral tablet	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.
Experimental: MDMA Then Placebo Then Methampetamine	Methamphetamine	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.
Experimental: Placebo Then MDMA Then Methamphetamine	Methamphetamine	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.
Experimental: Placebo Then MDMA Then Methamphetamine	MDMA	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.
Experimental: Methampetamine Then Placebo Then MDMA	Methamphetamine	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.

Primary Outcome Measures

Name	Time	Method
Profile of Mood States	Time Frame: Baseline-72 hours after completion of the sessions	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.

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States