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Effects of MDMA on Social and Emotional Processing
Plain-language guide to NCT01849419: not phased interventional trial of Oxytocin, 65 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01849419
- Phase
- not phased
- Status
- completed
- Start
- 2010-07
- Completion (planned or actual)
- 2013-03
- Participants
- 65 (actual)
- Design
- na, double-blind, basic_science
- Conditions studied
- Drug Addiction
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested Oxytocin.
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.
It had 1 arm (groups): Single group (experimental).
Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 65 actual participants took part.
It was open to people of any sex aged from 18 years up to 35 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: High school education,. No psychiatric disorders,. Occasional MDMA use.
The full record lists 7 inclusion and 4 exclusion criteria; among the exclusions: current medications,; night shift work,; abnormal electrocardiogram,.
How the Study Was Run
The set-up was single-group and double-blind.
Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
Those kept unaware of assignments: participant and investigator.
It started in 2010-07 with completion listed for 2013-03.
It ran at 1 site in United States.
Its stated primary purpose is basic science.
What Was Measured
Researchers chose this as the main measure: Emotional Recognition (MDMA) (time frame: 15 minutes during each session). Emotional Recognition (Oxytocin) (time frame: 15 minutes during each session). Emotional Recognition (Placebo) (time frame: 15 minutes during each session).
It also tracked 21 secondary outcomes, for example Subjective Response to MDMA (Ratings of 'Feel Drug'), Subjective Response to Oxytocin (Ratings of 'Feel Drug'), Subjective Response to Placebo (Ratings of 'Feel Drug'), Subjective Response to MDMA (Ratings of 'Feel High'), Subjective Response to Oxytocin (Ratings of 'Feel High') and Subjective Response to Placebo (Ratings of 'Feel High').
What This Means in Plain Language
Put simply, this is a not phased trial of Oxytocin in 65 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Oxytocin compound page, all human trials.
Our Notes on the Compound
Oxytocin: A peptide hormone with established obstetric medical uses and a less settled role in research on behavior, sexual function and appetite.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.