Effects of Drugs on Responses to Brain and Emotional Processes (MAT)

The University of Chicago

Status and phase: Completed; Early Phase 1

Conditions: Healthy; Autism Spectrum Disorder

Treatments: Drug: MDMA; Drug: Placebo oral tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04053036

IRB19-0174

Details and patient eligibility

About

To study the effects of a psychostimulant on responses to affective touch in individuals with a range of autistic traits

Enrollment: 22 patients

Sex: All

Ages: 21 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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22 participants in 2 patient groups

Placebo Then MDMA

Experimental group

Description:

Participants first receive placebo at their first session in the laboratory. Then will return to the laboratory 72 hours later and will receive MDMA (1.5 mg/kg)

Treatment:

Drug: Placebo oral tablet

Drug: MDMA

MDMA Then Placebo

Experimental group

Description:

Participants first receive MDMA (1.5 mg/kg) at their first session in the laboratory. Then will return to the laboratory 72 hours later and will receive placebo.

Treatment:

Drug: Placebo oral tablet

Drug: MDMA