Dronabinol Treatment for Marijuana Addiction (MARINOL)
|ClinicalTrials.gov Identifier: NCT00217971|
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : November 1, 2011
Last Update Posted : April 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Marijuana Abuse||Drug: Dronabinol Drug: Placebo||Phase 2|
Marijuana addiction is associated with significant withdrawal symptoms, including anxiety, irritability, bodily discomfort, and insomnia. The purpose of this study is to determine the effectiveness of dronabinol in reducing withdrawal symptoms.
During this twelve-week, double-blind, placebo-controlled study, study visits will occur twice each week. During study visits, participants will receive either placebo or medication. Throughout the study, all participants will receive individualized psychotherapy sessions. At each study visit, vital signs, self-report ratings, and urine samples will be collected. Participants will have a follow-up evaluation at month 6.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||156 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Study of Dronabinol in the Treatment of Marijuana Addiction|
|Study Start Date :||March 2005|
|Primary Completion Date :||December 2009|
|Study Completion Date :||December 2009|
Active Comparator: Dronabinol
Dronabinol: 20mg bid for a daily maximum dose of 40mg.
Other Name: Marinol
Placebo Comparator: Placebo
- Proportion of Patients Abstinent From Marijuana During Weeks 7 and 8 of the Trial [ Time Frame: weeks 7 and 8 ]Timeline Followback self report data was collected. This daily report was used to assess the proportion of patients abstinent during weeks 7 and 8 of the clinical trial.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00217971
|United States, New York|
|Research Foundation for Mental Hygiene, Inc.|
|New York, New York, United States, 10032|
|Principal Investigator:||Frances R Levin, MD||New York State Psychiatric Institute|