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

The University of Chicago

Status and phase: Completed; Early Phase 1

Conditions: Motivation; Stimulant Use; MDMA ('Ecstasy'); Social Behavior

Treatments: Drug: MDMA; Drug: Methamphetamine; Drug: placebo oral tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT05379959

IRB21-1568

Details and patient eligibility

About

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

Enrollment: 43 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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43 participants in 3 patient groups

Experimental: Placebo Then MDMA Then Methamphetamine

Experimental group

Description:

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.

Treatment:

Drug: Methamphetamine

Drug: placebo oral tablet

Drug: MDMA

Experimental: MDMA Then Placebo Then Methampetamine

Experimental group

Description:

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.

Treatment:

Drug: Methamphetamine

Drug: placebo oral tablet

Drug: MDMA

Experimental: Methampetamine Then Placebo Then MDMA

Experimental group

Description:

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.

Treatment:

Drug: Methamphetamine

Drug: placebo oral tablet

Drug: MDMA