Dronabinol Treatment for Marijuana Addiction - Tabular View

Tracking Information

First Received Date ^ICMJE

September 16, 2005

Last Updated Date

October 15, 2009

Start Date ^ICMJE

March 2005

Estimated Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Reduction of marijuana use or abstinence from marijuana (measured weekly and at Month 6) [ Time Frame: weekly ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Reduction on marijuana use/abstinence from marijuana, weekly, Month 6

Change History

Complete list of historical versions of study NCT00217971 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Withdrawal symptoms (measured bi-weekly from Week 1 through 12) [ Time Frame: biweekly ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Withdrawl symptoms, biweekly, Weeks 1 through 12

Descriptive Information

Brief Title ^ICMJE

Dronabinol Treatment for Marijuana Addiction

Official Title ^ICMJE

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 Description

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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Marijuana Abuse

Intervention ^ICMJE

Drug: Dronabinol
Drug: Placebo

Study Arms / Comparison Groups

Active Comparator: Dronabinol
Placebo Comparator: placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

December 2009

Estimated Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Meets DSM-IV criteria for current marijuana dependence and reports marijuana as primary drug of abuse
Individuals must report using marijuana at least 5 days a week and have a marijuana positive urine drug screen on the day of study entry

Exclusion Criteria:

Meets criteria for current psychiatric disorder requiring psychiatric intervention
History of seizures
Known sensitivity to dronabinol
Unstable medical conditions
Physical dependence on any other drugs (excluding nicotine) that would require medical detoxification
Currently taking psychotropic medication with benefit for any other illness than treatment of insomnia
Pregnant or breast-feeding

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00217971

Responsible Party

Frances R. Levin, M.D, Columbia University/NYSPI

Study ID Numbers ^ICMJE

NIDA-09236-11, P50-09236-11, DPMC

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

New York State Psychiatric Institute

Investigators ^ICMJE

Principal Investigator:

Frances R Levin, MD

New York State Psychiatric Institute

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP