Clinical Trials Directory

Trials / Completed

CompletedNCT01849419

Effects of MDMA on Social and Emotional Processing

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
65 (actual)
Sponsor
University of Chicago · Academic / Other
Sex
All
Age
18 Years – 35 Years
Healthy volunteers
Accepted

Summary

The main aim of the study is to investigate the effects of ±3,4-methylenedioxymethamphetamine (MDMA; ecstasy) on social and emotional processing in healthy humans. Ecstasy is a widely used recreational drug, with over 2 million Americans reporting use of the drug in 2006. With this number of users, and evidence that high doses of MDMA are neurotoxic in laboratory animals, the public health implications of ecstasy use may be substantial. Certain subjective effects of this drug distinguish it from other stimulants, and may contribute to its widespread use: That is, users report that ecstasy produces profound feelings of empathy and closeness to others. These so-called 'empathogenic' effects, which may reflect the distinctive neurochemical profile of action of the drug, have yet to be characterized in controlled laboratory studies. The investigators propose to characterize the effects of MDMA on measures of social and emotional processing that may contribute to this 'empathogenic' profile, including measures of emotion recognition, emotional responsiveness and sociability. The investigators will assess effects of MDMA (0, 0.75 and 1.5 mg/kg up to 125 mg) one active control drug (oxytocin: 20 IU) in 100 volunteers who report some prior ecstasy use. Oxytocin will be used because it appears to produce pro-social behavioral effects resembling those attributed to MDMA.

Conditions

Interventions

TypeNameDescription
DRUGWithin-subjects (MDMA)This was a within-subjects, double-blind, double-dummy, placebo-controlled experiment during which each participant received a single dose of MDMA (0.75, 1.5 mg/kg) on two session, oxytocin (20 IU) as an active control on one session (see second Intervention), and placebo one session (see third intervention).
DRUGWithin-subjects (oxytocin)This was a within-subjects, double-blind, double-dummy, placebo-controlled experiment during which each participant received oxytocin (20 IU) on one session, MDMA on two sessions (see first Intervention), and placebo on one session (see third Intervention).
DRUGWithin-subjects (placebo)This was a within-subjects, double-blind, double-dummy, placebo-controlled experiment during which each participant received placebo on one session, MDMA on two sessions (see first Intervention), and oxytocin (20 IU) on one session (see second Intervention).

Timeline

Start date
2010-07-01
Primary completion
2013-03-01
Completion
2013-03-01
First posted
2013-05-08
Last updated
2014-12-18
Results posted
2014-12-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01849419. Inclusion in this directory is not an endorsement.