Back to resultsEffects of Drugs on Responses to Brain and Emotional Processes (MAT)
Primary Purpose
Autism Spectrum Disorder, Healthy
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
MDMA
Placebo oral tablet
Sponsored by
About this trial
This is an interventional basic science trial for Autism Spectrum Disorder
Eligibility 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
Sites / Locations
- University of Chicago
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Placebo Then MDMA
MDMA Then Placebo
Arm Description
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)
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.
Outcomes
Primary Outcome Measures
Change in responses to affective touch
Participants will complete an affective touch task during which time they will rate pleasantness of touch
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04053036
Brief Title
Effects of Drugs on Responses to Brain and Emotional Processes
Acronym
MAT
Official Title
Effects of MDMA on Responses to Affective Touch in Individuals With a Range of Autistic Traits
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
August 8, 2019 (Actual)
Primary Completion Date
April 12, 2021 (Actual)
Study Completion Date
April 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To study the effects of a psychostimulant on responses to affective touch in individuals with a range of autistic traits
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Healthy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo Then MDMA
Arm Type
Experimental
Arm Description
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)
Arm Title
MDMA Then Placebo
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
MDMA
Intervention Description
Participants will be given 1.5mg/kg of MDMA
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
Participants will be given a placebo capsule that will only contain lactose.
Primary Outcome Measure Information:
Title
Change in responses to affective touch
Description
Participants will complete an affective touch task during which time they will rate pleasantness of touch
Time Frame
time 0 and approximately six weeks later
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harriet de Wit
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Drugs on Responses to Brain and Emotional Processes
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