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NCT00480441 · ClinicalTrials.gov registry record · Phase 2
Effectiveness Study of Dronabinol and BRENDA for the Treatment of Cannabis Withdrawal
A Phase 2 study of Marijuana Dependence, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 2
- Development phase
- 61
- Enrollment target
- 1
- Study location
NCT00480441: Completed Phase 2 study of Marijuana Dependence, sponsored by University of Pennsylvania.
NCT00480441 is a Phase 2 study of Marijuana Dependence that has completed, run by University of Pennsylvania. The registered enrollment target is 61 participants, below the 82-participant average among 6 other Marijuana Dependence trials with a reported enrollment target (26% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00480441, a Phase 2 study of Marijuana Dependence, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 61 participants
- Enrollment target
- 1
- Study location
Study Summary
This treatment study is targeted specifically for those who want to stop using marijuana. We want to find out if patients who are dependent on marijuana and want to stop using are helped by a combination of the drug dronabinol and six sessions of individual therapy (BRENDA). Dronabinol is a pill form of the active ingredient in marijuana (THC). Currently, dronabinol is approved for the treatment of nausea in people receiving cancer chemotherapy and as an appetite stimulant in people with AIDS. In some studies, dronabinol reduced the amount of psychological and physical discomfort experienced when people stopped using marijuana. One purpose of our study is to see if people who are on dronabinol have fewer problems with psychological and physical discomfort than those who are on a placebo. In addition to treatment, this research trial will also be measuring the reactions of subjects to drug-related cues, and also to computer-presented tasks unrelated to drug use. We may examine whether the response to these cues/tasks either predicts treatment outcome, or is affected by your treatment. This information may also help us to understand the ways in which chronic drug use causes changes in our subjects' mental functioning and how those changes respond to treatment. In addition to participation in the treatment research trial, some subjects may be asked to undergo a brain scan in an MRI. The purpose of the brain scan research project is to measure brain reactions with a non-invasive, non-radioactive imaging technique known as fMRI (functional magnetic resonance imaging) in marijuana subjects before and after treatment with the medication dronabinol or with an inactive substance (placebo).
Primary Outcome
Functional MRI brain response to cannabis vs neutral cues. Higher T values represent increased blood flow in response to cues.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Dronabinol
- BEHAVIORAL BRENDA therapy
Study Locations (1)
Pennsylvania
- Treatment Research Center at the University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2006-08 |
| Est. Completion | 2009-07 |
| Phase | Phase 2 |
What the finished NCT00480441 record still lists
NCT00480441 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 82-participant average among 6 other Marijuana Dependence trials with a reported enrollment target (26% lower).
The record links to 1 condition, with Marijuana Dependence appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT00480441 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00480441 about?
NCT00480441 is a clinical study titled "Effectiveness Study of Dronabinol and BRENDA for the Treatment of Cannabis Withdrawal". This treatment study is targeted specifically for those who want to stop using marijuana. We want to find out if patients who are dependent on marijuana and want to stop using are helped by a combination of the drug dronabinol and six sessions of individual therapy (BRENDA). Dronabinol is a pill for...
What is the current status of trial NCT00480441?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2006-08. Estimated completion is 2009-07.
What conditions does trial NCT00480441 study?
This clinical trial studies the following conditions: Marijuana Dependence.
What interventions are being tested in trial NCT00480441?
The interventions under investigation include: Placebo (DRUG), Dronabinol (DRUG), BRENDA therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT00480441?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00480441 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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