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Effect of Stimulant Drugs on Social Perception (ESP)

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: NCT03790618
Recruitment Status : Unknown
Verified December 2018 by University of Chicago.
Recruitment status was:  Recruiting
First Posted : December 31, 2018
Last Update Posted : December 31, 2018
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Tracking Information
First Submitted Date  ICMJE November 30, 2018
First Posted Date  ICMJE December 31, 2018
Last Update Posted Date December 31, 2018
Actual Study Start Date  ICMJE June 1, 2016
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 28, 2018)
Responses to affective touch [ Time Frame: End of study (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 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 Effect of Stimulant Drugs on Social Perception
Official Title  ICMJE Effect of Stimulant Drugs on Social Perception
Brief Summary The study will improve our understanding of the "prosocial" effects of ± 3,4-Methylenedioxymethamphetamine (MDMA), relative to a prototypical stimulant, methamphetamine (MA). The investigators seek to characterize the "uniquely social" effects of MDMA.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Effects of MDMA on Healthy Human Volunteers
Intervention  ICMJE
  • Drug: 3,4-Methylenedioxymethamphetamine
    Participants will be given 0.75mg/kg of 1.5mg/kg MDMA
  • Drug: methamphetamine
    Please see above.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Subjects will attend one session during which they will receive a placebo capsule.
    Interventions:
    • Drug: 3,4-Methylenedioxymethamphetamine
    • Drug: methamphetamine
  • Experimental: Low dose MDMA
    Subjects will attend one session during which they will receive 0.75mg/kg MDMA.
    Interventions:
    • Drug: 3,4-Methylenedioxymethamphetamine
    • Drug: methamphetamine
  • Experimental: High dose MDMA
    Subjects will attend one session during which they will receive 1.5mg/kg MDMA.
    Interventions:
    • Drug: 3,4-Methylenedioxymethamphetamine
    • Drug: methamphetamine
  • Experimental: Methamphetamine
    Subjects will attend one session during which they will receive 20mg methamphetamine.
    Interventions:
    • Drug: 3,4-Methylenedioxymethamphetamine
    • Drug: methamphetamine
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 28, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2020
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • High school degree
  • English fluency
  • Healthy
  • Has used MDMA

Exclusion Criteria:

  • Pregnant or trying to become pregnant
  • Any medical or psychiatry condition
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 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 NCT03790618
Other Study ID Numbers  ICMJE IRB15-780
Has Data Monitoring Committee No
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
Responsible Party University of Chicago
Study Sponsor  ICMJE University of Chicago
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Chicago
Verification Date December 2018

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