NCT01148342

Neurobiology and Pharmacokinets of Acute MDMA Administration

Completed Phase 1 Last updated 12 December 2019

What this trial tests

Phase 1 trial testing MDMA in Substance-Related Disorders in 187 participants. Completed in 18 July 2012.

Timeline

10 February 2004

18 July 2012

Quick facts

Lead sponsor	National Institute on Drug Abuse (NIDA)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Primary purpose	other
Enrollment	187
Start date	10 February 2004
Estimated completion	18 July 2012
Sites	1 location across United States

Drugs / interventions tested

• MDMA — full drug profile →
• (+/-)3,4-methylenedioxymethamphetamine Hydrochloride, MDMA HCI Capsules — full drug profile →

Conditions studied

• Substance-Related Disorders — all drugs for Substance-Related Disorders →

Sponsor

National Institute on Drug Abuse (NIDA)

Who can join

Adults 18 to 40, any sex, with Substance-Related Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Use of functional imaging across clinical phases in CNS drug development.
   Borsook D, Becerra L, Fava M. · · 2013 · cited 46× · PMID 23860483 · DOI 10.1038/tp.2013.43
2. MDMA pharmacokinetics: A population and physiologically based pharmacokinetics model-informed analysis.
   Huestis MA, Smith WB, Leonowens C, Blanchard R, et al · · 2025 · cited 1× · PMID 39592887 · DOI 10.1002/psp4.13282