Effects of MDMA on Social and Emotional Processing

NCT01849419 | Completed Results

• 2 other identifiers: 10-120-BR21DA026570
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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

Drug Addiction

Outcome Measures

Primary Outcomes (3)

• Emotional Recognition (MDMA)

  Participants complete the Dynamic Emotional Identification Task, or DEIT (Wardle et al. 2012) following MDMA, oxytocin or placebo administration during which they identify emotional facial expressions presented on the screen. Participants completed this task once during each of the sessions. In the DEIT, 10 actors performed angry, fearful, sad, and happy expressions, for a total of 40 sequences, which were presented in random order. Each sequence consisted of 50 "frames" progressing from 0 to 100% emotional intensity at 2% steps, producing a color video of an emotional expression developing. Participants were instructed to "press the space bar as soon as you know what expression is being displayed." This ended the sequence and presented options of "angry," "fearful," "sad," and "happy." Perception of expressions was quantified as the intensity (0-100 %) of the face when the participant pressed the space bar for correctly identified sequences.

  15 minutes during each session

• Emotional Recognition (Oxytocin)

  Participants completed the Dynamic Emotional Identification Task, or DEIT (Wardle et al. 2012) following MDMA, oxytocin or placebo administration during which they identify emotional facial expressions presented on the screen. Participants completed this task once during each of the sessions. In the DEIT, 10 actors performed angry, fearful, sad, and happy expressions, for a total of 40 sequences, which were presented in random order. Each sequence consisted of 50 "frames" progressing from 0 to 100% emotional intensity at 2% steps, producing a color video of an emotional expression developing. Participants were instructed to "press the space bar as soon as you know what expression is being displayed." This ended the sequence and presented options of "angry," "fearful," "sad," and "happy." Perception of expressions was quantified as the intensity (0-100 %) of the face when the participant pressed the space bar for correctly identified sequences.

  15 minutes during each session

• Emotional Recognition (Placebo)

  Participants completed the Dynamic Emotional Identification Task, or DEIT (Wardle et al. 2012) following MDMA, oxytocin or placebo administration during which they identify emotional facial expressions presented on the screen. Participants completed this task once during each of the sessions. In the DEIT, 10 actors performed angry, fearful, sad, and happy expressions, for a total of 40 sequences, which were presented in random order. Each sequence consisted of 50 "frames" progressing from 0 to 100% emotional intensity at 2% steps, producing a color video of an emotional expression developing. Participants were instructed to "press the space bar as soon as you know what expression is being displayed." This ended the sequence and presented options of "angry," "fearful," "sad," and "happy." Perception of expressions was quantified as the intensity (0-100 %) of the face when the participant pressed the space bar for correctly identified sequences.

  15 minutes during each session

Secondary Outcomes (21)

• Subjective Response to MDMA (Ratings of 'Feel Drug')

  repeatedly during each session

• Subjective Response to Oxytocin (Ratings of 'Feel Drug')

  repeatedly during each session

• Subjective Response to Placebo (Ratings of 'Feel Drug')

  repeatedly during each session

• Subjective Response to MDMA (Ratings of 'Feel High')

  repeatedly during each session

• Subjective Response to Oxytocin (Ratings of 'Feel High')

  repeatedly during each session

Study Arms (1)

Single group

EXPERIMENTAL

Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.

Drug: Within-subjects (MDMA); Drug: Within-subjects (oxytocin); Drug: Within-subjects (placebo)

Interventions

Within-subjects (MDMA) DRUG

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).

Single group

Within-subjects (oxytocin) DRUG

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).

Single group

Within-subjects (placebo) DRUG

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).

Single group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy,
• normal weight,
• high school education,
• normal electrocardiogram,
• no psychiatric disorders,
• occasional MDMA use

You may not qualify if:

• current medications,
• night shift work,
• abnormal electrocardiogram,
• medical problems

Sponsors & Collaborators

• University of Chicago: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Links

• MDMA drug information
• US FDA resources

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

N-Methyl-3,4-methylenedioxyamphetamine; Oxytocin

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Behavioral measures may not have been obtained at optimal times to detect oxytocin effects. Placebo and oxytocin nasal spray formulations differed slightly. Other potential limitations are the selection of participants, or the doses administered.

Results Point of Contact

• Title: Dr. Harriet de Wit
• Organization: University of Chicago

hdew@uchicago.edu

(773) 702-3560

Study Officials

• Harriet de Wit, PhD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2013
• First Posted: May 8, 2013
• Study Start: July 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: December 18, 2014
• Results First Posted: December 18, 2014

Record last verified: 2014-12

Locations

US (1)