Primary outcomeMean· 15 minutes during each session
Emotional Recognition (MDMA)
| Group | Value (percent intensity) | Spread |
|---|---|---|
| Single Group | 55.9 | 1.5 |
Trial · Interventional
CompletedNot applicableResults postedRegistry dataEffects of MDMA on Social and Emotional Processing
Overview
- Status
- Completed
- Phase
- Not applicable
- Enrollment
- 65 participants (actual)
- Sponsor
- University of Chicago · Other
- Design
- Allocation not applicable · Double masking
- Countries
1 country
United States
- Start
- Jul 2010
- Primary completion
- Mar 2013
- Completion
- Mar 2013
- First posted
- 8 May 2013 (estimated)
- Last update posted
- 18 Dec 2014 (estimated)
- Conditions
- Drug Addiction
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20102011201220132014
- N/A
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Within-subjects (MDMA)Drug
- Within-subjects (oxytocin)Drug
- Within-subjects (placebo)Drug
Arms1
Experimental
Single group
Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
Primary outcomes3
Outcomes the sponsor listed as primary.
Emotional Recognition (MDMA)
Time frame · 15 minutes during each session
Registry description
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
Registry description
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
Registry description
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 outcomes(20)
Subjective Response to MDMA (Ratings of 'Feel Drug')
Time frame · repeatedly during each session
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
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").
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeMean· 15 minutes during each session
Emotional Recognition (Oxytocin)
| Group | Value (percent intensity) | Spread |
|---|---|---|
| Single Group | 59.0 | 1.4 |
Primary outcomeMean· 15 minutes during each session
Emotional Recognition (Placebo)
| Group | Value (percent intensity) | Spread |
|---|---|---|
| Single Group | 58.9 | 1.3 |
Secondary and other outcome results(5)
Secondary outcomeMean· repeatedly during each session
Subjective Response to MDMA (Ratings of 'Feel Drug')
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Single Group | 45.5 | 4.5 |
Secondary outcomeMean· repeatedly during each session
Subjective Response to Oxytocin (Ratings of 'Feel Drug')
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Single Group | 10.4 | 1.5 |
Secondary outcomeMean· repeatedly during each session
Subjective Response to Placebo (Ratings of 'Feel Drug')
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Single Group | 10.7 | 2.0 |
Secondary outcomeMean· repeatedly during each session
Subjective Response to MDMA (Ratings of 'Feel High')
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Single Group | 43.4 | 4.4 |
Secondary outcomeMean· repeatedly during each session
Subjective Response to Oxytocin (Ratings of 'Feel High')
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Single Group | 10.0 | 1.4 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Single GroupHealthy volunteers received all drug conditions including placebo (within-subjects design). Within-subjects (MDMA and placebo): This was a within-subjects, double-blind, double-dummy, placebo-controlled experiment during which each participant received MDMA (0.75, 1.5 mg/kg)and placebo. Participants received oxytocin as an active control on one session (see second Intervention). Within-subjects (oxytocin and placebo): This was a within-subjects, double-blind, double-dummy, placebo-controlled experiment during which each participant received oxytocin (20 IU) on one session and placebo on one session. Participants received MDMA on the other two sessions (see first Intervention). | – | 0 / 65 | 0 / 65 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 35 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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
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