Clinical Trial: Dronabinol Treatment for Marijuana Addiction

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of Dronabinol in the Treatment of Marijuana Addiction

Brief Summary: The purpose of this study is to determine if dronabinol decreases the symptoms of marijuana addiction and withdrawal.

Detailed Summary:

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.


Sponsor: New York State Psychiatric Institute

Current Primary Outcome: 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.


Original Primary Outcome: Reduction on marijuana use/abstinence from marijuana, weekly, Month 6

Current Secondary Outcome:

Original Secondary Outcome: Withdrawl symptoms, biweekly, Weeks 1 through 12

Information By: New York State Psychiatric Institute

Dates:
Date Received: September 16, 2005
Date Started: March 2005
Date Completion:
Last Updated: April 6, 2016
Last Verified: April 2016