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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Effects of MDMA on Healthy Human Volunteers Drug: 3,4-Methylenedioxymethamphetamine Drug: methamphetamine Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Stimulant Drugs on Social Perception
Actual Study Start Date : June 1, 2016
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Methamphetamine

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Subjects will attend one session during which they will receive a placebo capsule.
 Drug: 3,4-Methylenedioxymethamphetamine
Participants will be given 0.75mg/kg of 1.5mg/kg MDMA

Drug: methamphetamine
Please see above.
Experimental: Low dose MDMA
Subjects will attend one session during which they will receive 0.75mg/kg MDMA.
 Drug: 3,4-Methylenedioxymethamphetamine
Participants will be given 0.75mg/kg of 1.5mg/kg MDMA

Drug: methamphetamine
Please see above.
Experimental: High dose MDMA
Subjects will attend one session during which they will receive 1.5mg/kg MDMA.
 Drug: 3,4-Methylenedioxymethamphetamine
Participants will be given 0.75mg/kg of 1.5mg/kg MDMA

Drug: methamphetamine
Please see above.
Experimental: Methamphetamine
Subjects will attend one session during which they will receive 20mg methamphetamine.
 Drug: 3,4-Methylenedioxymethamphetamine
Participants will be given 0.75mg/kg of 1.5mg/kg MDMA

Drug: methamphetamine
Please see above.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant or trying to become pregnant
  • Any medical or psychiatry condition
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): NCT03790618


Contacts
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Contact: Matthew Bona mbona@yoda.bsd.uchicago.edu
Contact: Anya Bershad abershad@uchicago.edu

Locations
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United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Matthew Bona         
Contact: Anya Bershad       mbona@yoda.bsd.uchicago.edu   
Sponsors and Collaborators
University of Chicago
More Information
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT03790618    
Other Study ID Numbers: IRB15-780
First Posted: December 31, 2018    Key Record Dates
Last Update Posted: December 31, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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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Methamphetamine
N-Methyl-3,4-methylenedioxyamphetamine
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
 Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Adrenergic Agents
Central Nervous System Stimulants
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors