N/A
N=65
Effects of MDMA on Social and Emotional Processing
Drug Addiction
Bottom Line
View on ClinicalTrials.gov: NCT01849419 ↗Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Emotional Recognition (MDMA) — 55.9 percent intensity
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Within-subjects (MDMA) (Drug); Within-subjects (oxytocin) (Drug); Within-subjects (placebo) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Chicago
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Emotional Recognition (MDMA) |
55.9 | — |
| PRIMARY Emotional Recognition (Oxytocin) |
59.0 | — |
| PRIMARY Emotional Recognition (Placebo) |
58.9 | — |
| SECONDARY Subjective Response to MDMA (Ratings of 'Feel Drug') |
45.5 | — |
| SECONDARY Subjective Response to Oxytocin (Ratings of 'Feel Drug') |
10.4 | — |
| SECONDARY Subjective Response to Placebo (Ratings of 'Feel Drug') |
10.7 | — |
| SECONDARY Subjective Response to MDMA (Ratings of 'Feel High') |
43.4 | — |
| SECONDARY Subjective Response to Oxytocin (Ratings of 'Feel High') |
10.0 | — |
| SECONDARY Subjective Response to Placebo (Ratings of 'Feel High') |
8.6 | — |
| SECONDARY Subjective Response to MDMA (Ratings of 'Feel Sociable') |
11.7 | — |
| SECONDARY Subjective Response to Oxytocin (Ratings of 'Feel Sociable') |
0.1 | — |
| SECONDARY Subjective Response to Placebo (Ratings of 'Feel Sociable') |
-2.6 | — |
| SECONDARY Cardiovascular Response to MDMA (Heart Rate) |
11.1 | — |
| SECONDARY Cardiovascular Response to Oxytocin (Heart Rate) |
-4.1 | — |
| SECONDARY Cardiovascular Response to Placebo (Heart Rate) |
-4.2 | — |
| SECONDARY Cardiovascular Response to MDMA (Systolic Blood Pressure) |
16.4 | — |
| SECONDARY Cardiovascular Response to Oxytocin (Systolic Blood Pressure) |
2.8 | — |
| SECONDARY Cardiovascular Response to Placebo (Systolic Blood Pressure) |
3.6 | — |
| SECONDARY Cardiovascular Response to MDMA (Diastolic Blood Pressure) |
10.0 | — |
| SECONDARY Cardiovascular Response to Oxytocin (Diastolic Blood Pressure) |
2.4 | — |
| SECONDARY Cardiovascular Response to Placebo (Diastolic Blood Pressure) |
3.1 | — |
| SECONDARY Motivation to Socialize (MDMA) |
5.5 | — |
| SECONDARY Motivation to Socialize (Oxytocin) |
4.9 | — |
| SECONDARY Motivation to Socialize (Placebo) |
4.6 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01849419). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.