CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 61 enrolled
Drug / intervention
Dronabinol +2 moredrug
Likely dose
Dronabinol 10mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00480441
NCT00480441Phase 2Completed

A Phase II Double-Blind Placebo-Controlled Trial of Dronabinol and BRENDA for the Treatment of Cannabis Withdrawal

University of Pennsylvania·interventional·Posted May 31, 2007·Updated Jul 29, 2019

In Brief

A Phase 2 clinical trial evaluating Dronabinol, BRENDA therapy, and 1 other intervention for Marijuana Dependence. Completed, enrolled 61 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 31, 2007
Enrollment StartAug 1, 2006
Primary CompletionJun 1, 2009
Study CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 19.1 years ago

Interventions

Dronabinoldrug

10mg capsules taken 4 times daily for 2 weeks and then tapered over 1 week

BRENDA therapybehavioral

weekly therapy sessions for 6 weeks

Placebodrug

4 capsules daily for 2 weeks followed by a 1 week taper