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Effects of MDMA on Social and Emotional Processing

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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:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Chicago

Tracking Information
First Submitted Date  ICMJE April 23, 2013
First Posted Date  ICMJE May 8, 2013
Results First Submitted Date  ICMJE May 29, 2014
Results First Posted Date  ICMJE December 18, 2014
Last Update Posted Date December 18, 2014
Study Start Date  ICMJE July 2010
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2014)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 3, 2013)
Emotional Recognition [ Time Frame: 3-4 weeks ]
Participants complete a computerized task following MDMA or placebo administration during which they identify emotional facial expressions presented on the screen.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2014)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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").
  • 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").
  • 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").
Original Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2013)
  • Subjective responses to MDMA [ Time Frame: 3-4 weeks ]
    Subjects complete standardized mood questionnaires after receiving MDMA or placebo on each of the four sessions. Blood pressure and heart rate are also measured at these times.
  • Motivation to socialize [ Time Frame: 3-4 weeks ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of MDMA on Social and Emotional Processing
Official Title  ICMJE Effects of MDMA on Social and Emotional Processing
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Drug Addiction
Intervention  ICMJE
  • 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).
Study Arms  ICMJE Experimental: Single group
Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
Interventions:
  • Drug: Within-subjects (MDMA)
  • Drug: Within-subjects (oxytocin)
  • Drug: Within-subjects (placebo)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 3, 2013)
65
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01849419
Other Study ID Numbers  ICMJE 10-120-B
R21DA026570 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Chicago
Study Sponsor  ICMJE University of Chicago
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Harriet de Wit, PhD University of Chicago
PRS Account University of Chicago
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP