Effects of Stimulants on Behavioral and Neural Markers of Social Motivation, Ability, and Neural Markers of Social Function
Overview
- Phase
- Early Phase 1
- Status
- Completed
- Sponsor
- University of Chicago
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Profile of Mood States
Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Experimental: Placebo Then MDMA Then 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.
Intervention: MDMA (Drug)
Experimental: Placebo Then MDMA Then 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.
Intervention: Methamphetamine (Drug)
Experimental: Placebo Then MDMA Then 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.
Intervention: placebo oral tablet (Drug)
Experimental: MDMA Then Placebo Then Methampetamine
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.
Intervention: MDMA (Drug)
Experimental: MDMA Then Placebo Then Methampetamine
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.
Intervention: Methamphetamine (Drug)
Experimental: MDMA Then Placebo Then Methampetamine
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.
Intervention: placebo oral tablet (Drug)
Experimental: Methampetamine Then Placebo Then 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.
Intervention: MDMA (Drug)
Experimental: Methampetamine Then Placebo Then 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.
Intervention: Methamphetamine (Drug)
Experimental: Methampetamine Then Placebo Then 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.
Intervention: placebo oral tablet (Drug)
Outcomes
Primary Outcomes
Profile of Mood States
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported