Effects of MDMA on Social and Emotional Processing

• ClinicalTrials.gov Identifier: NCT01849419
• Recruitment Status: Completed
• First Posted: May 8, 2013
• Results First Posted: December 18, 2014
• Last Update Posted: December 18, 2014
• Sponsor: University of Chicago
• Collaborator: National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): University of Chicago

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Drug Addiction	Drug: Within-subjects (MDMA); Drug: Within-subjects (oxytocin); Drug: Within-subjects (placebo)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 65 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: Effects of MDMA on Social and Emotional Processing
• Study Start Date: July 2010
• Actual Primary Completion Date: March 2013
• Actual Study Completion Date: March 2013

Arms and Interventions

Arm

Intervention/treatment

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

Drug: Within-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).; Drug: Within-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).; Drug: Within-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).

Outcome Measures

Primary Outcome Measures :

1. Emotional Recognition (MDMA) [ Time Frame: 15 minutes during each session ]

   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.

2. Emotional Recognition (Oxytocin) [ Time Frame: 15 minutes during each session ]

   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.

3. Emotional Recognition (Placebo) [ Time Frame: 15 minutes during each session ]

   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.

Secondary Outcome Measures :

1. Subjective Response to MDMA (Ratings of 'Feel Drug') [ Time Frame: repeatedly during each session ]
   Participants completed this visual analog questionnaire item during which participants selected a rating between 0 ("Not at all") to 100 ("Extremely"). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline.
2. Subjective Response to Oxytocin (Ratings of 'Feel Drug') [ Time Frame: repeatedly during each session ]
   Participants completed this visual analog questionnaire item during which participants selected a rating between 0 ("Not at all") to 100 ("Extremely"). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline.
3. Subjective Response to Placebo (Ratings of 'Feel Drug') [ Time Frame: repeatedly during each session ]
   Participants completed this visual analog questionnaire item during which participants selected a rating between 0 ("Not at all") to 100 ("Extremely"). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline.
4. Subjective Response to MDMA (Ratings of 'Feel High') [ Time Frame: repeatedly during each session ]
   Participants completed this visual analog questionnaire item during which participants selected a rating between 0 ("Not at all") to 100 ("Extremely"). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline.
5. Subjective Response to Oxytocin (Ratings of 'Feel High') [ Time Frame: repeatedly during each session ]
   Participants completed this visual analog questionnaire item during which participants selected a rating between 0 ("Not at all") to 100 ("Extremely"). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline.
6. Subjective Response to Placebo (Ratings of 'Feel High') [ Time Frame: repeatedly during each session ]
   Participants completed this visual analog questionnaire item during which participants selected a rating between 0 ("Not at all") to 100 ("Extremely"). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline.
7. Subjective Response to MDMA (Ratings of 'Feel Sociable') [ Time Frame: repeatedly during each session ]
   Participants completed this visual analog questionnaire item during which participants selected a rating between 0 ("Not at all") to 100 ("Extremely"). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline.
8. Subjective Response to Oxytocin (Ratings of 'Feel Sociable') [ Time Frame: repeatedly during each session ]
   Participants completed this visual analog questionnaire item during which participants selected a rating between 0 ("Not at all") to 100 ("Extremely"). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline.
9. Subjective Response to Placebo (Ratings of 'Feel Sociable') [ Time Frame: repeatedly during each session ]
   Participants completed this visual analog questionnaire item during which participants selected a rating between 0 ("Not at all") to 100 ("Extremely"). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline.
10. Cardiovascular Response to MDMA (Heart Rate) [ Time Frame: repeatedly during each session ]
    Heart rate (bpm) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.
11. Cardiovascular Response to Oxytocin (Heart Rate) [ Time Frame: repeatedly during each session ]
    Heart rate (bpm) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.
12. Cardiovascular Response to Placebo (Heart Rate) [ Time Frame: repeatedly during each session ]
    Heart rate (bpm) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.
13. Cardiovascular Response to MDMA (Systolic Blood Pressure) [ Time Frame: repeatedly during each session ]
    Systolic Blood Pressure (mmHg) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.
14. Cardiovascular Response to Oxytocin (Systolic Blood Pressure) [ Time Frame: repeatedly during each session ]
    Systolic Blood Pressure (mmHg) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.
15. Cardiovascular Response to Placebo (Systolic Blood Pressure) [ Time Frame: repeatedly during each session ]
    Systolic Blood Pressure (mmHg) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.
16. Cardiovascular Response to MDMA (Diastolic Blood Pressure) [ Time Frame: repeatedly during each session ]
    Diastolic Blood Pressure (mmHg) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.
17. Cardiovascular Response to Oxytocin (Diastolic Blood Pressure) [ Time Frame: repeatedly during each session ]
    Diastolic Blood Pressure (mmHg) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.
18. Cardiovascular Response to Placebo (Diastolic Blood Pressure) [ Time Frame: repeatedly during each session ]
    Diastolic Blood Pressure (mmHg) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.
19. Motivation to Socialize (MDMA) [ Time Frame: 5 minutes during each session ]
    Participants complete the social choice task following administration of MDMA or placebo during which they choose between spending time 1) talking with another person; 2) sitting quietly alone; or 3) solving word problems. Choices were rated on a scale of 1 to 10 (with 10 indicating the highest level of desire to engage in that activity). The main outcome measure was desire to socialize (i.e., rating of "talking to another person").
20. Motivation to Socialize (Oxytocin) [ Time Frame: 5 minutes during each session ]
    Participants complete the social choice task following administration of MDMA or placebo during which they choose between spending time 1) talking with another person; 2) sitting quietly alone; or 3) solving word problems. Choices were rated on a scale of 1 to 10 (with 10 indicating the highest level of desire to engage in that activity). The main outcome measure was desire to socialize (i.e., rating of "talking to another person").
21. Motivation to Socialize (Placebo) [ Time Frame: 5 minutes during each session ]
    Participants complete the social choice task following administration of MDMA or placebo during which they choose between spending time 1) talking with another person; 2) sitting quietly alone; or 3) solving word problems. Choices were rated on a scale of 1 to 10 (with 10 indicating the highest level of desire to engage in that activity). The main outcome measure was desire to socialize (i.e., rating of "talking to another person").

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 35 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• 18-35,
• healthy,
• normal weight,
• high school education,
• normal electrocardiogram,
• no psychiatric disorders,
• occasional MDMA use

Exclusion Criteria:

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

Contacts and Locations

Locations

United States, Illinois

University of Chicago

Chicago, Illinois, United States, 60637

Sponsors and Collaborators

University of Chicago

National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Harriet de Wit, PhD; University of Chicago

More Information

Additional Information:

MDMA drug information 

US FDA resources 

• Responsible Party: University of Chicago
• ClinicalTrials.gov Identifier: NCT01849419
• Other Study ID Numbers: 10-120-B; R21DA026570 ( U.S. NIH Grant/Contract )
• First Posted: May 8, 2013
• Results First Posted: December 18, 2014
• Last Update Posted: December 18, 2014
• Last Verified: December 2014

Additional relevant MeSH terms:

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Oxytocin; Oxytocics; Reproductive Control Agents; Physiological Effects of Drugs