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

Effects of MDMA on Responses to Affective Touch in Individuals With a Range of Autistic Traits

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

Study Overview

• Status: Completed
• Conditions: Healthy; Autism Spectrum Disorder
• Intervention / Treatment: Drug: MDMA; Drug: Placebo oral tablet

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo Then 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)	Drug: MDMA; Participants will be given 1.5mg/kg of MDMA; Drug: Placebo oral tablet; Participants will be given a placebo capsule that will only contain lactose.
Experimental: MDMA Then Placebo; 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.	Drug: MDMA; Participants will be given 1.5mg/kg of MDMA; Drug: Placebo oral tablet; Participants will be given a placebo capsule that will only contain lactose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in responses to affective touch	Participants will complete an affective touch task during which time they will rate pleasantness of touch	time 0 and approximately six weeks later

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Harriet de Wit, Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2019
• Primary Completion (Actual): April 12, 2021
• Study Completion (Actual): April 12, 2021

Study Registration Dates

• First Submitted: August 8, 2019
• First Submitted That Met QC Criteria: August 9, 2019
• First Posted (Actual): August 12, 2019

Study Record Updates

• Last Update Posted (Actual): June 9, 2021
• Last Update Submitted That Met QC Criteria: June 8, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: IRB19-0174

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No