Drug AddictionNCT01849419
Effects of MDMA on Social and Emotional Processing
A study testing Within-subjects (MDMA) and Within-subjects (oxytocin) in people with Drug Addiction, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Addiction
- What is being tested?
- Within-subjects (MDMA) and Within-subjects (oxytocin)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Mar 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-35,
- healthy,
- normal weight,
- high school education,
- normal electrocardiogram,
- no psychiatric disorders,
- occasional MDMA use
Who cannot join
- current medications,
- night shift work,
- abnormal electrocardiogram,
- medical problems
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Drug Addiction
- Being tested
- Within-subjects (MDMA), Within-subjects (oxytocin), Within-subjects (placebo)
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Within-subjects (MDMA)Drug
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).
Within-subjects (oxytocin)Drug
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).
Within-subjects (placebo)Drug
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 group | Role | What they receive |
|---|---|---|
| Single group | Experimental | Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design. Receives: Drug: Within-subjects (MDMA); Drug: Within-subjects (oxytocin); Drug: Within-subjects (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 minutes during each session
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.
Measured: 15 minutes during each session
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.
Measured: 15 minutes during each session
Secondary outcomes (21)
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.
Measured: repeatedly during each session
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.
Measured: repeatedly during each session
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.
Measured: repeatedly during each session
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.
Measured: repeatedly during each session
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.
Measured: repeatedly during each session
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.
Measured: repeatedly during each session
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.
Measured: repeatedly during each session
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.
Measured: repeatedly during each session
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.
Measured: repeatedly during each session
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.
Measured: repeatedly during each session
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.
Measured: repeatedly during each session
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.
Measured: repeatedly during each session
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.
Measured: repeatedly during each session
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.
Measured: repeatedly during each session
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.
Measured: repeatedly during each session
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.
Measured: repeatedly during each session
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.
Measured: repeatedly during each session
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.
Measured: repeatedly during each session
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").
Measured: 5 minutes during each session
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").
Measured: 5 minutes during each session
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").
Measured: 5 minutes during each session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2013 (estimated)
- Study startJul 2010
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Drug AddictionStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Harriet de Wit, PhD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01849419
- Sponsor's protocol ID
- 10-120-B
- Other IDs
- R21DA026570
- Status last verified
- Dec 2014
- First submitted
- 23 Apr 2013
- Last updated
- 18 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of MDMA on Social and Emotional Processing
- ClinicalTrials.gov ID
- NCT01849419
- Acronym / sponsor ID
- 10-120-B
- Conditions
- Drug Addiction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 8 May 2013 (estimated)
- Results
- Posted 18 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group | Experimental | Drug: Within-subjects (MDMA), Drug: Within-subjects (oxytocin), Drug: Within-subjects (placebo)Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 18-35,
- healthy,
- normal weight,
- high school education,
- normal electrocardiogram,
Key exclusion criteria (4 listed)
- current medications,
- night shift work,
- abnormal electrocardiogram,
- medical problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Single group |
| 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 | Single group |
| 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). | Drug | Single group |
Primary outcome
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.
21 secondary outcomes
Subjective Response to MDMA (Ratings of 'Feel Drug')
Time frame: repeatedly during each session
Subjective Response to Oxytocin (Ratings of 'Feel Drug')
Time frame: repeatedly during each session
Subjective Response to Placebo (Ratings of 'Feel Drug')
Time frame: repeatedly during each session
Subjective Response to MDMA (Ratings of 'Feel High')
Time frame: repeatedly during each session
Subjective Response to Oxytocin (Ratings of 'Feel High')
Time frame: repeatedly during each session
Subjective Response to Placebo (Ratings of 'Feel High')
Time frame: repeatedly during each session
Subjective Response to MDMA (Ratings of 'Feel Sociable')
Time frame: repeatedly during each session
Subjective Response to Oxytocin (Ratings of 'Feel Sociable')
Time frame: repeatedly during each session
Subjective Response to Placebo (Ratings of 'Feel Sociable')
Time frame: repeatedly during each session
Cardiovascular Response to MDMA (Heart Rate)
Time frame: repeatedly during each session
Cardiovascular Response to Oxytocin (Heart Rate)
Time frame: repeatedly during each session
Cardiovascular Response to Placebo (Heart Rate)
Time frame: repeatedly during each session
Cardiovascular Response to MDMA (Systolic Blood Pressure)
Time frame: repeatedly during each session
Cardiovascular Response to Oxytocin (Systolic Blood Pressure)
Time frame: repeatedly during each session
Cardiovascular Response to Placebo (Systolic Blood Pressure)
Time frame: repeatedly during each session
Cardiovascular Response to MDMA (Diastolic Blood Pressure)
Time frame: repeatedly during each session
Cardiovascular Response to Oxytocin (Diastolic Blood Pressure)
Time frame: repeatedly during each session
Cardiovascular Response to Placebo (Diastolic Blood Pressure)
Time frame: repeatedly during each session
Motivation to Socialize (MDMA)
Time frame: 5 minutes during each session
Motivation to Socialize (Oxytocin)
Time frame: 5 minutes during each session
Motivation to Socialize (Placebo)
Time frame: 5 minutes during each session
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- MDMA drug informationLink provided by the sponsor.
- US FDA resourcesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harriet de Wit, PhD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Within-subjects (MDMA) and Within-subjects (oxytocin) in people with Drug Addiction, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotional Recognition (MDMA) (time frame: 15 minutes during each session). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2014.