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

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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
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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
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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

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Arms and Interventions
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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
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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
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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
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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
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United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Harriet de Wit Principal Investigator
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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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

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