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Effects of Stimulants on Behavioral and Neural Markers of Social Motivation, Ability, and Neural Markers of Social Function (MASM)

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ClinicalTrials.gov Identifier: NCT05379959
Recruitment Status : Recruiting
First Posted : May 18, 2022
Last Update Posted : May 18, 2022
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Tracking Information
First Submitted Date  ICMJE May 13, 2022
First Posted Date  ICMJE May 18, 2022
Last Update Posted Date May 18, 2022
Actual Study Start Date  ICMJE May 11, 2022
Estimated Primary Completion Date July 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2022)
Profile of Mood States [ Time Frame: Time Frame: Baseline-72 hours after completion of the sessions ]
The POMS measures individuals' mood states. This is a validated scale to measure positive and negative mood states. The POMS contains 30 items and assesses six identified mood factors: Tension-Anxiety, Depression-Ejection, Anger- Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. Scoring of the instrument provides a global score of 0 to 120 or individual domain scores. Lower scores indicate better mood state. The POMS brief form is a simple self-rating instrument.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
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 Stimulants on Behavioral and Neural Markers of Social Motivation, Ability, and Neural Markers of Social Function
Official Title  ICMJE Effects of Stimulants on Behavioral and Neural Markers of Social Motivation, Ability, and Neural Markers of Social Function
Brief Summary To study the effects of MDMA, compared to a prototypical stimulant, on social motivation, social ability, and neural indices of social function in healthy volunteers
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, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE
  • Stimulant Use
  • MDMA ('Ecstasy')
  • Social Behavior
  • Motivation
Intervention  ICMJE
  • Drug: MDMA
    Participants will be given 125 mg of MDMA.
  • Drug: Methamphetamine
    Participants will be given 20 mg of MA.
  • Drug: placebo oral tablet
    Participants will be given a placebo capsule that will only contain lactose.
Study Arms  ICMJE
  • Experimental: Experimental: Placebo Then MDMA Then Methamphetamine
    Participants first receive placebo at their first session in the laboratory. Then will return to the laboratory 5 days later and will receive 125 mg MDMA. Finally, 5 days later will return to the laboratory and will receive 20 mg of MA.
    Interventions:
    • Drug: MDMA
    • Drug: Methamphetamine
    • Drug: placebo oral tablet
  • Experimental: Experimental: MDMA Then Placebo Then Methampetamine
    Participants first receive 125 mg of MDMA at their first session in the laboratory. Then will return to the laboratory 5 days later and will receive placebo. Finally, 5 days later will return to the laboratory and will receive 20 mg of MA.
    Interventions:
    • Drug: MDMA
    • Drug: Methamphetamine
    • Drug: placebo oral tablet
  • Experimental: Experimental: Methampetamine Then Placebo Then MDMA
    Participants first receive 20 mg of MA at their first session in the laboratory. Then will return to the laboratory 5 days later and will receive placebo. Finally, 5 days later will return to the laboratory and will receive 125 mg of MDMA.
    Interventions:
    • Drug: MDMA
    • Drug: Methamphetamine
    • 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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 13, 2022)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2023
Estimated Primary Completion Date July 1, 2023   (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 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Matthew Bona 7737023560 dewitlab@yoda.bsd.uchicago.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05379959
Other Study ID Numbers  ICMJE IRB21-1568
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: Undecided
Current Responsible Party University of Chicago
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Chicago
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Chicago
Verification Date May 2022

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