Neurobiology and Pharmacokinets of Acute MDMA Administration
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|ClinicalTrials.gov Identifier: NCT01148342|
Recruitment Status : Completed
First Posted : June 22, 2010
Last Update Posted : December 12, 2019
- 3,4-Methylenedioxymethamphetamine (MDMA), commonly known as ecstasy, is a synthetic psychoactive drug that has shown a steep increase in recreational use and abuse by young people in recent years. Research studies have reported that chronic MDMA users who also consume other legal and illegal substance show memory deficits; however, because of the combination of drugs often involved, it is difficult to determine MDMA s contribution to these effects.
- Only a few studies have examined the immediate physical and behavioral effects of MDMA given at dose levels commonly used in young adults. Researchers are interested in using functional magnetic resonance imaging (fMRI) to examine changes in brain activity and function in MDMA users compared with users of other drugs and non-drug-using individuals.
- To evaluate the effects of MDMA on thinking and brain function.
- Individuals between 18 and 30 years of age who are (1) current users of MDMA (2), current drug users who do not use MDMA, or (3) healthy non-drug-using volunteers.
- Participants will complete one training session and three scanning sessions.
- Before the start of the study, participants will complete questionnaires about medical and psychological history, and provide information about past or current drug use. Researchers will introduce the tasks to be performed during the scanning session(s), and will allow participants to practice the tests.
- Participants will provide urine, saliva, and hair samples for testing before the start of the study, and multiple times during each scanning session.
- Participants who use MDMA and participants who use other drugs will stay overnight at the clinical center prior to each scanning session. Participants who do not use drugs can spend the night prior to scanning or arrive at the clinical center on the morning of the scanning session.
- Participants who use MDMA will receive either MDMA or a placebo during the scanning sessions, and will not be told which one they have received. Because of the nature of MDMA, participants will be required to stay at the clinical center until the effects of the drug have worn off, and will be required to return to the clinical center on the following day for a follow-up examination.
- During the study, participants will be asked to do one or more tasks selected by the researchers. The tasks will be performed on a computer in an MRI machine, and may involve receiving monetary rewards for actions, memory and reaction-time tests, or other tests that involve responding to instructions on the screen.
|Condition or disease||Intervention/treatment||Phase|
|Substance-Related Disorders||Drug: MDMA Drug: (+/-)3,4-methylenedioxymethamphetamine Hydrochloride, MDMA HCI Capsules||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||187 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Neurobiology and Pharmacokinetics of Acute MDMA Administration|
|Study Start Date :||February 10, 2004|
|Actual Study Completion Date :||July 18, 2012|
- Drug: MDMA
- Drug: (+/-)3,4-methylenedioxymethamphetamine Hydrochloride, MDMA HCI Capsules
0, 1.0 & 1.6 mg/kg
- MDMA effects on human brain function and relationship between plasma MDMA concentrations and human brain function.
- MDMA pharmacokinetics in various biological matrices.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01148342
|United States, Maryland|
|National Institute on Drug Abuse, Biomedical Research Center (BRC)|
|Baltimore, Maryland, United States, 21224|
|Principal Investigator:||Marilyn Huestis, Ph.D.||National Institute on Drug Abuse (NIDA)|