ESP: Effect of Stimulant Drugs on Social Perception

Sponsor

University of Chicago (Other)

Overall Status

Unknown status

CT.gov ID

NCT03790618

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Anticipated 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 :

Jun 1, 2016

Anticipated Primary Completion Date :

Jan 1, 2020

Anticipated Study Completion Date :

Jan 1, 2020

Arms and Interventions

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

Primary Outcome Measures

Responses to affective touch [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

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University of Chicago	Chicago	Illinois	United States	60637

Sponsors and Collaborators

University of Chicago

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Chicago

ClinicalTrials.gov Identifier:

NCT03790618

Other Study ID Numbers:

IRB15-780

First Posted:

Dec 31, 2018

Last Update Posted:

Dec 31, 2018

Last Verified:

Dec 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Methamphetamine

N-Methyl-3,4-methylenedioxyamphetamine

Study Results

No Results Posted as of Dec 31, 2018