Drug Addiction
Conditions
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.
Interventions
DRUGWithin-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).
DRUGWithin-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).
DRUGWithin-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).
Sponsors
National Institute on Drug Abuse (NIDA)
University of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emotional Recognition (MDMA) | 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) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Subjective Response to MDMA (Ratings of 'Feel High') | 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') | 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') | 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') | 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') | 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') | 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) | 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) | 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) | 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. |
| Subjective Response to MDMA (Ratings of 'Feel Drug') | 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 Oxytocin (Systolic Blood Pressure) | 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) | 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 (Diastolic Blood Pressure) | 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 MDMA (Diastolic Blood Pressure) | 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) | 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) | 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) | 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) | 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). |
| Cardiovascular Response to MDMA (Systolic Blood Pressure) | 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. |
| Subjective Response to Oxytocin (Ratings of 'Feel Drug') | 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') | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Single Group 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). | 65 |
| Total | 65 |
Baseline characteristics
| Characteristic | Single Group |
|---|---|
| Age, Continuous | 23.8 years STANDARD_DEVIATION 3.9 |
| Education | 14.6 years STANDARD_DEVIATION 1.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 65 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| MDMA use history | 15.0 lifetime uses STANDARD_DEVIATION 11.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 65 Participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 65 |
| serious Total, serious adverse events | 0 / 65 |
Outcome results
Primary
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.
Time frame: 15 minutes during each session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Group | Emotional Recognition (MDMA) | 55.9 percent intensity | Standard Error 1.5 |
Primary
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.
Time frame: 15 minutes during each session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Group | Emotional Recognition (Oxytocin) | 59.0 percent intensity | Standard Error 1.4 |
Primary
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.
Time frame: 15 minutes during each session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Group | Emotional Recognition (Placebo) | 58.9 percent intensity | Standard Error 1.3 |
Secondary
Cardiovascular Response to MDMA (Diastolic Blood Pressure)
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.
Time frame: repeatedly during each session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Group | Cardiovascular Response to MDMA (Diastolic Blood Pressure) | 10.0 mmHg | Standard Error 1.5 |
Secondary
Cardiovascular Response to MDMA (Heart Rate)
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.
Time frame: repeatedly during each session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Group | Cardiovascular Response to MDMA (Heart Rate) | 11.1 bpm | Standard Error 2.2 |
Secondary
Cardiovascular Response to MDMA (Systolic Blood Pressure)
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.
Time frame: repeatedly during each session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Group | Cardiovascular Response to MDMA (Systolic Blood Pressure) | 16.4 mmHg | Standard Error 1.9 |
Secondary
Cardiovascular Response to Oxytocin (Diastolic Blood Pressure)
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.
Time frame: repeatedly during each session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Group | Cardiovascular Response to Oxytocin (Diastolic Blood Pressure) | 2.4 mmHg | Standard Error 0.6 |
Secondary
Cardiovascular Response to Oxytocin (Heart Rate)
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.
Time frame: repeatedly during each session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Group | Cardiovascular Response to Oxytocin (Heart Rate) | -4.1 bpm | Standard Error 0.7 |
Secondary
Cardiovascular Response to Oxytocin (Systolic Blood Pressure)
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.
Time frame: repeatedly during each session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Group | Cardiovascular Response to Oxytocin (Systolic Blood Pressure) | 2.8 mmHg | Standard Error 0.7 |
Secondary
Cardiovascular Response to Placebo (Diastolic Blood Pressure)
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.
Time frame: repeatedly during each session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Group | Cardiovascular Response to Placebo (Diastolic Blood Pressure) | 3.1 mmHg | Standard Error 0.9 |
Secondary
Cardiovascular Response to Placebo (Heart Rate)
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.
Time frame: repeatedly during each session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Group | Cardiovascular Response to Placebo (Heart Rate) | -4.2 bpm | Standard Error 0.9 |
Secondary
Cardiovascular Response to Placebo (Systolic Blood Pressure)
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.
Time frame: repeatedly during each session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Group | Cardiovascular Response to Placebo (Systolic Blood Pressure) | 3.6 mmHg | Standard Error 1.1 |
Secondary
Motivation to Socialize (MDMA)
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).
Time frame: 5 minutes during each session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Group | Motivation to Socialize (MDMA) | 5.5 units on a scale | Standard Error 0.4 |
Secondary
Motivation to Socialize (Oxytocin)
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).
Time frame: 5 minutes during each session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Group | Motivation to Socialize (Oxytocin) | 4.9 units on a scale | Standard Error 0.3 |
Secondary
Motivation to Socialize (Placebo)
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).
Time frame: 5 minutes during each session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Group | Motivation to Socialize (Placebo) | 4.6 units on a scale | Standard Error 0.3 |
Secondary
Subjective Response to MDMA (Ratings of 'Feel Drug')
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.
Time frame: repeatedly during each session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Group | Subjective Response to MDMA (Ratings of 'Feel Drug') | 45.5 units on a scale | Standard Error 4.5 |
Secondary
Subjective Response to MDMA (Ratings of 'Feel High')
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.
Time frame: repeatedly during each session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Group | Subjective Response to MDMA (Ratings of 'Feel High') | 43.4 units on a scale | Standard Error 4.4 |
Secondary
Subjective Response to MDMA (Ratings of 'Feel Sociable')
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.
Time frame: repeatedly during each session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Group | Subjective Response to MDMA (Ratings of 'Feel Sociable') | 11.7 units on a scale | Standard Error 3.8 |
Secondary
Subjective Response to Oxytocin (Ratings of 'Feel Drug')
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.
Time frame: repeatedly during each session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Group | Subjective Response to Oxytocin (Ratings of 'Feel Drug') | 10.4 units on a scale | Standard Error 1.5 |
Secondary
Subjective Response to Oxytocin (Ratings of 'Feel High')
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.
Time frame: repeatedly during each session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Group | Subjective Response to Oxytocin (Ratings of 'Feel High') | 10.0 units on a scale | Standard Error 1.4 |
Secondary
Subjective Response to Oxytocin (Ratings of 'Feel Sociable')
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.
Time frame: repeatedly during each session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Group | Subjective Response to Oxytocin (Ratings of 'Feel Sociable') | 0.1 units on a scale | Standard Error 1.5 |
Secondary
Subjective Response to Placebo (Ratings of 'Feel Drug')
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.
Time frame: repeatedly during each session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Group | Subjective Response to Placebo (Ratings of 'Feel Drug') | 10.7 units on a scale | Standard Error 2 |
Secondary
Subjective Response to Placebo (Ratings of 'Feel High')
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.
Time frame: repeatedly during each session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Group | Subjective Response to Placebo (Ratings of 'Feel High') | 8.6 units on a scale | Standard Error 1.8 |
Secondary
Subjective Response to Placebo (Ratings of 'Feel Sociable')
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.
Time frame: repeatedly during each session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Group | Subjective Response to Placebo (Ratings of 'Feel Sociable') | -2.6 units on a scale | Standard Error 1.9 |