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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

Tracking Information
First Submitted Date  ICMJE August 8, 2019
First Posted Date  ICMJE August 12, 2019
Last Update Posted Date June 9, 2021
Actual Study Start Date  ICMJE August 8, 2019
Actual Primary Completion Date April 12, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Drugs on Responses to Brain and Emotional Processes
Official Title  ICMJE Effects of MDMA on Responses to Affective Touch in Individuals With a Range of Autistic Traits
Brief Summary To study the effects of a psychostimulant on responses to affective touch in individuals with a range of autistic traits
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Autism Spectrum Disorder
  • Healthy
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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)
    Interventions:
    • Drug: MDMA
    • Drug: Placebo oral tablet
  • 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.
    Interventions:
    • Drug: MDMA
    • Drug: Placebo oral tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 8, 2021)
24
Original Estimated Enrollment  ICMJE
 (submitted: August 9, 2019)
45
Actual Study Completion Date  ICMJE April 12, 2021
Actual Primary Completion Date April 12, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04053036
Other Study ID Numbers  ICMJE IRB19-0174
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Chicago
Study Sponsor  ICMJE University of Chicago
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Harriet de Wit Principal Investigator
PRS Account University of Chicago
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP