Trial Outcomes & Findings for Effects of MDMA on Social and Emotional Processing (NCT NCT01849419)

NCT ID: NCT01849419

Last Updated: 2014-12-18

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 65 participants
• Primary outcome timeframe: 15 minutes during each session
• Results posted on: 2014-12-18

Participant Flow

From July 2010-June 2012, healthy male and non-pregnant female occasional ecstasy users, aged between 18 and 35 years, were recruited through posters, print and internet advertisements and word-of-mouth referrals. All recruitment and study procedures were conducted in a medical laboratory setting.

Participants were excluded for one of or more of the following reasons: history of adverse effects from ecstasy; current Axis I disorders; medical conditions precluding participation including high blood pressure, abnormal EKG, first degree relatives with heart disease; pregnancy or lactation (females), and significant nasal or sinus condition.

Participant milestones

Measure	Single Group Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized. This was a within-subjects, double-blind, double-dummy, placebo-controlled experiment during which each participant received MDMA (0.75, 1.5 mg/kg), oxytocin (20 IU), and placebo over the course of four experimental sessions. Drug order was randomized for each participant.
Overall Study STARTED	65
Overall Study COMPLETED	65
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of MDMA on Social and Emotional Processing

Baseline characteristics by cohort

Measure	Single Group n=65 Participants Healthy 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).
Age, Continuous	23.8 years STANDARD_DEVIATION 3.9 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	65 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	65 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Education	14.6 years STANDARD_DEVIATION 1.4 • n=5 Participants
MDMA use history	15.0 lifetime uses STANDARD_DEVIATION 11.2 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Single Group n=65 Participants Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.
Emotional Recognition (MDMA)	55.9 percent intensity Standard Error 1.5

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Single Group n=65 Participants Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.
Emotional Recognition (Oxytocin)	59.0 percent intensity Standard Error 1.4

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Single Group n=65 Participants Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.
Emotional Recognition (Placebo)	58.9 percent intensity Standard Error 1.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Single Group n=65 Participants Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.
Subjective Response to MDMA (Ratings of 'Feel Drug')	45.5 units on a scale Standard Error 4.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Single Group n=65 Participants Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.
Subjective Response to Oxytocin (Ratings of 'Feel Drug')	10.4 units on a scale Standard Error 1.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Single Group n=65 Participants Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.
Subjective Response to Placebo (Ratings of 'Feel Drug')	10.7 units on a scale Standard Error 2.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Single Group n=65 Participants Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.
Subjective Response to MDMA (Ratings of 'Feel High')	43.4 units on a scale Standard Error 4.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Single Group n=65 Participants Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.
Subjective Response to Oxytocin (Ratings of 'Feel High')	10.0 units on a scale Standard Error 1.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Single Group n=65 Participants Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.
Subjective Response to Placebo (Ratings of 'Feel High')	8.6 units on a scale Standard Error 1.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Single Group n=65 Participants Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.
Subjective Response to MDMA (Ratings of 'Feel Sociable')	11.7 units on a scale Standard Error 3.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Single Group n=65 Participants Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.
Subjective Response to Oxytocin (Ratings of 'Feel Sociable')	0.1 units on a scale Standard Error 1.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Single Group n=65 Participants Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.
Subjective Response to Placebo (Ratings of 'Feel Sociable')	-2.6 units on a scale Standard Error 1.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Single Group n=65 Participants Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.
Cardiovascular Response to MDMA (Heart Rate)	11.1 bpm Standard Error 2.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Single Group n=65 Participants Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.
Cardiovascular Response to Oxytocin (Heart Rate)	-4.1 bpm Standard Error 0.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Single Group n=65 Participants Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.
Cardiovascular Response to Placebo (Heart Rate)	-4.2 bpm Standard Error 0.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Single Group n=65 Participants Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.
Cardiovascular Response to MDMA (Systolic Blood Pressure)	16.4 mmHg Standard Error 1.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Single Group n=65 Participants Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.
Cardiovascular Response to Oxytocin (Systolic Blood Pressure)	2.8 mmHg Standard Error 0.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Single Group n=65 Participants Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.
Cardiovascular Response to Placebo (Systolic Blood Pressure)	3.6 mmHg Standard Error 1.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Single Group n=65 Participants Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.
Cardiovascular Response to MDMA (Diastolic Blood Pressure)	10.0 mmHg Standard Error 1.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Single Group n=65 Participants Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.
Cardiovascular Response to Oxytocin (Diastolic Blood Pressure)	2.4 mmHg Standard Error 0.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Single Group n=65 Participants Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.
Cardiovascular Response to Placebo (Diastolic Blood Pressure)	3.1 mmHg Standard Error 0.9

SECONDARY outcome

Timeframe: 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").

Outcome measures

Measure	Single Group n=65 Participants Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.
Motivation to Socialize (MDMA)	5.5 units on a scale Standard Error 0.4

SECONDARY outcome

Timeframe: 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").

Outcome measures

Measure	Single Group n=65 Participants Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.
Motivation to Socialize (Oxytocin)	4.9 units on a scale Standard Error 0.3

SECONDARY outcome

Timeframe: 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").

Outcome measures

Measure	Single Group n=65 Participants Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.
Motivation to Socialize (Placebo)	4.6 units on a scale Standard Error 0.3

Adverse Events

Single Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Harriet de Wit

University of Chicago

Phone: (773) 702-3560

Email: hdew@uchicago.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place