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NCT01148342 · ClinicalTrials.gov registry record · Phase 1
Neurobiology and Pharmacokinets of Acute MDMA Administration
A Phase 1 study, sponsored by National Institute on Drug Abuse (NIDA).
- Completed
- Registry status
- Phase 1
- Development phase
- 187
- Enrollment target
NCT01148342 is a Phase 1 study that has completed, run by National Institute on Drug Abuse (NIDA). The registered enrollment target is 187 participants.
The verdict
NCT01148342, a Phase 1 study, has completed, sponsored by National Institute on Drug Abuse (NIDA).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 187 participants
- Enrollment target
Study Summary
Background: * 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. Objectives: \- To evaluate the effects of MDMA on thinking and brain function. Eligibility: \- 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. Design: * 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 scann
Interventions
- DRUG MDMA
- DRUG (+/-)3,4-methylenedioxymethamphetamine Hydrochloride, MDMA HCI Capsules
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 187 participants |
| Start Date | 2004-02-10 |
| Est. Completion | 2012-07-18 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01148342
The ClinicalTrials.gov registry entry for NCT01148342 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 187 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Drug Abuse (NIDA), which has 335 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which MDMA is the first listed.
NCT01148342 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01148342 about?
NCT01148342 is a clinical study titled "Neurobiology and Pharmacokinets of Acute MDMA Administration". Background: * 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 ...
What is the current status of trial NCT01148342?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 187 participants. The study started on 2004-02-10. Estimated completion is 2012-07-18.
What interventions are being tested in trial NCT01148342?
The interventions under investigation include: MDMA (DRUG), (+/-)3,4-methylenedioxymethamphetamine Hydrochloride, MDMA HCI Capsules (DRUG).
Who is sponsoring clinical trial NCT01148342?
This trial is sponsored by National Institute on Drug Abuse (NIDA), which has 335 total clinical trials registered on ClinicalTrials.gov.
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