We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
To study the effects of a psychostimulant on responses to affective touch in individuals with a range of autistic traits

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Healthy Drug: MDMA Drug: Placebo oral tablet Early Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Layout table for investigator information
Principal Investigator: Harriet de Wit Principal Investigator
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders