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

Study Overview
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Brief Summary
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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

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

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

Intervention / Treatment
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* Drug: MDMA
* Drug: Methamphetamine
* Drug: placebo oral tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Placebo Then MDMA Then Methamphetamine<br>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. | Drug: MDMA<br>* Participants will be given 125 mg of MDMA.<br>Drug: Methamphetamine<br>* Participants will be given 20 mg of MA.<br>Drug: placebo oral tablet<br>* Participants will be given a placebo capsule that will only contain lactose.<br>|
| Experimental: Experimental: MDMA Then Placebo Then Methampetamine<br>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. | Drug: MDMA<br>* Participants will be given 125 mg of MDMA.<br>Drug: Methamphetamine<br>* Participants will be given 20 mg of MA.<br>Drug: placebo oral tablet<br>* Participants will be given a placebo capsule that will only contain lactose.<br>|
| Experimental: Experimental: Methampetamine Then Placebo Then MDMA<br>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. | Drug: MDMA<br>* Participants will be given 125 mg of MDMA.<br>Drug: Methamphetamine<br>* Participants will be given 20 mg of MA.<br>Drug: placebo oral tablet<br>* Participants will be given a placebo capsule that will only contain lactose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |