Effect of Stimulant Drugs on Social Perception

NCT ID: NCT03790618

Last Updated: 2024-01-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-01

Study Completion Date

2018-08-01

Brief Summary

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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

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Conditions

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Healthy MDMA ('Ecstasy')

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Placebo

Subjects will attend one session during which they will receive a placebo capsule.

Group Type PLACEBO_COMPARATOR

3,4-Methylenedioxymethamphetamine

Intervention Type DRUG

Participants will be given 0.75mg/kg of 1.5mg/kg MDMA

methamphetamine

Intervention Type DRUG

Please see above.

Low dose MDMA

Subjects will attend one session during which they will receive 0.75mg/kg MDMA.

Group Type EXPERIMENTAL

3,4-Methylenedioxymethamphetamine

Intervention Type DRUG

Participants will be given 0.75mg/kg of 1.5mg/kg MDMA

methamphetamine

Intervention Type DRUG

Please see above.

High dose MDMA

Subjects will attend one session during which they will receive 1.5mg/kg MDMA.

Group Type EXPERIMENTAL

3,4-Methylenedioxymethamphetamine

Intervention Type DRUG

Participants will be given 0.75mg/kg of 1.5mg/kg MDMA

methamphetamine

Intervention Type DRUG

Please see above.

Methamphetamine

Subjects will attend one session during which they will receive 20mg methamphetamine.

Group Type EXPERIMENTAL

3,4-Methylenedioxymethamphetamine

Intervention Type DRUG

Participants will be given 0.75mg/kg of 1.5mg/kg MDMA

methamphetamine

Intervention Type DRUG

Please see above.

Interventions

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3,4-Methylenedioxymethamphetamine

Participants will be given 0.75mg/kg of 1.5mg/kg MDMA

Intervention Type DRUG

methamphetamine

Please see above.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pregnant or trying to become pregnant
* Any medical or psychiatry condition
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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Bershad AK, Hsu DT, de Wit H. MDMA enhances positive affective responses to social feedback. J Psychopharmacol. 2024 Mar;38(3):297-304. doi: 10.1177/02698811231224153. Epub 2024 Jan 27.

Reference Type DERIVED
PMID: 38279662 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB15-780

Identifier Type: -

Identifier Source: org_study_id

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