Effect of Stimulant Drugs on Social Perception (ESP)

March 29, 2023 updated by: University of Chicago
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant or trying to become pregnant
  • Any medical or psychiatry condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 on a likert scale of 1-7, with higher scores indicating greater ratings of pleasantness
End of study (time 0 and approximately six weeks later)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

November 30, 2018

First Submitted That Met QC Criteria

December 28, 2018

First Posted (Actual)

December 31, 2018

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

March 29, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB15-780

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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