Effects of Drugs on Responses to Brain and Emotional Processes (MAT)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04053036 |
Recruitment Status :
Completed
First Posted : August 12, 2019
Last Update Posted : June 9, 2021
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Condition or disease | Intervention/treatment | Phase |
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Autism Spectrum Disorder Healthy | Drug: MDMA Drug: Placebo oral tablet | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Basic Science |
Official Title: | Effects of MDMA on Responses to Affective Touch in Individuals With a Range of Autistic Traits |
Actual Study Start Date : | August 8, 2019 |
Actual Primary Completion Date : | April 12, 2021 |
Actual Study Completion Date : | April 12, 2021 |

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)
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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. |
- Change in responses to affective touch [ Time Frame: time 0 and approximately six weeks later ]Participants will complete an affective touch task during which time they will rate pleasantness of touch

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Ages Eligible for Study: | 21 Years to 40 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04053036
United States, Illinois | |
University of Chicago | |
Chicago, Illinois, United States, 60637 |
Principal Investigator: | Harriet de Wit | Principal Investigator |
Responsible Party: | University of Chicago |
ClinicalTrials.gov Identifier: | NCT04053036 |
Other Study ID Numbers: |
IRB19-0174 |
First Posted: | August 12, 2019 Key Record Dates |
Last Update Posted: | June 9, 2021 |
Last Verified: | June 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Autism Spectrum Disorder Child Development Disorders, Pervasive Neurodevelopmental Disorders Mental Disorders |