Clinical trial NCT01849419: Effects of MDMA on Social and Emotional Processing
Official title: Effects of MDMA on Social and Emotional Processing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Addiction
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2013-05-08
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Emotional Recognition (MDMA)
timeFrame: 15 minutes during each session
measure: Emotional Recognition (Oxytocin)
timeFrame: 15 minutes during each session
measure: Emotional Recognition (Placebo)
timeFrame: 15 minutes during each session
Secondary outcomes:
measure: Subjective Response to MDMA (Ratings of 'Feel Drug')
timeFrame: repeatedly during each session
measure: Subjective Response to Oxytocin (Ratings of 'Feel Drug')
timeFrame: repeatedly during each session
measure: Subjective Response to Placebo (Ratings of 'Feel Drug')
timeFrame: repeatedly during each session
measure: Subjective Response to MDMA (Ratings of 'Feel High')
timeFrame: repeatedly during each session
measure: Subjective Response to Oxytocin (Ratings of 'Feel High')
timeFrame: repeatedly during each session
measure: Subjective Response to Placebo (Ratings of 'Feel High')
timeFrame: repeatedly during each session
measure: Subjective Response to MDMA (Ratings of 'Feel Sociable')
timeFrame: repeatedly during each session
measure: Subjective Response to Oxytocin (Ratings of 'Feel Sociable')
timeFrame: repeatedly during each session
measure: Subjective Response to Placebo (Ratings of 'Feel Sociable')
timeFrame: repeatedly during each session
measure: Cardiovascular Response to MDMA (Heart Rate)
timeFrame: repeatedly during each session
measure: Cardiovascular Response to Oxytocin (Heart Rate)
timeFrame: repeatedly during each session
measure: Cardiovascular Response to Placebo (Heart Rate)
timeFrame: repeatedly during each session
measure: Cardiovascular Response to MDMA (Systolic Blood Pressure)
timeFrame: repeatedly during each session
measure: Cardiovascular Response to Oxytocin (Systolic Blood Pressure)
timeFrame: repeatedly during each session
measure: Cardiovascular Response to Placebo (Systolic Blood Pressure)
timeFrame: repeatedly during each session
measure: Cardiovascular Response to MDMA (Diastolic Blood Pressure)
timeFrame: repeatedly during each session
measure: Cardiovascular Response to Oxytocin (Diastolic Blood Pressure)
timeFrame: repeatedly during each session
measure: Cardiovascular Response to Placebo (Diastolic Blood Pressure)
timeFrame: repeatedly during each session
measure: Motivation to Socialize (MDMA)
timeFrame: 5 minutes during each session
measure: Motivation to Socialize (Oxytocin)
timeFrame: 5 minutes during each session
measure: Motivation to Socialize (Placebo)
timeFrame: 5 minutes during each session
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Harriet de Wit, PhD
role: PRINCIPAL_INVESTIGATOR
References: