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

October 9, 2024 updated by: University of Chicago

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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.
1.5 hrs after drug or placebo administration.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Principal Investigator: Harriet de Wit, Principal Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 (Estimated)

November 25, 2024

Last Update Submitted That Met QC Criteria

October 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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