Effects of Drugs on Responses to Brain and Emotional Processes

Early Phase 1

Completed

• Conditions: Autism Spectrum Disorder; Healthy
• Interventions: Drug: MDMA; Drug: Placebo oral tablet

• Registration Number: NCT04053036
• Lead Sponsor: University of Chicago

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-08
• Study First Submitted: 2019-08-08
• Study First Submitted QC: 2019-08-09
• Study First Posted: 2019-08-12
• Primary Completion: 2021-04-12
• Study Completion: 2021-04-12
• Results First Submitted: 2022-04-26
• Status Verified: 2024-01
• Results First Submitted QC: 2024-10-09
• Last Update Submitted: 2024-10-09
• Results First Posted: 2024-11-25
• Last Update Posted: 2024-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
MDMA Then Placebo	MDMA	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.
MDMA Then Placebo	Placebo oral tablet	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.
Placebo Then MDMA	Placebo oral tablet	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)
Placebo Then MDMA	MDMA	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)

Primary Outcome Measures

Name	Time	Method
Change in Responses to Affective Touch	1.5 hrs after drug or placebo administration.	Participants will complete an affective touch task during which time they will rate pleasantness of touch on a scale of -10 to +10 using an analog scale. Higher ratings indicate greater pleasantness.

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States