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

Motivation Clinical Trial

— MASM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05379959
• Other study ID #: IRB21-1568
• Status: Completed
• Phase: Early Phase 1
• Start date: May 11, 2022
• Est. completion date: October 24, 2023

Study information

• Verified date: January 2024
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: October 24, 2023
• Est. primary completion date: October 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Motivation
• Social Behavior
• Stimulant Use

Intervention

Drug:
• MDMA
Participants will be given 125 mg of MDMA.
• Methamphetamine
Participants will be given 20 mg of MA.
• placebo oral tablet
Participants will be given a placebo capsule that will only contain lactose.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Profile of Mood States	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.	Time Frame: Baseline-72 hours after completion of the sessions