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Dronabinol Treatment for Marijuana Addiction (MARINOL)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00217971
First received: September 16, 2005
Last updated: June 28, 2012
Last verified: June 2012

September 16, 2005
June 28, 2012
March 2005
December 2009   (final data collection date for primary outcome measure)
Proportion of Patients Abstinent From Marijuana During Weeks 7 and 8 of the Trial [ Time Frame: weeks 7 and 8 ] [ Designated as safety issue: No ]
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.
Reduction on marijuana use/abstinence from marijuana, weekly, Month 6
Complete list of historical versions of study NCT00217971 on ClinicalTrials.gov Archive Site
Not Provided
Withdrawl symptoms, biweekly, Weeks 1 through 12
Not Provided
Not Provided
 
Dronabinol Treatment for Marijuana Addiction
A Randomized, Double-Blind, Placebo-Controlled Study of Dronabinol in the Treatment of Marijuana Addiction

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Marijuana Abuse
  • Drug: Dronabinol
    Dronabinol
    Other Name: Marinol
  • Drug: Placebo
    placebo
  • Active Comparator: Dronabinol
    Dronabinol: 20mg bid for a daily maximum dose of 40mg.
    Intervention: Drug: Dronabinol
  • Placebo Comparator: Placebo
    placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
156
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00217971
#4886-NIDA-09236-11, P50DA009236, P50DA009236-11, DPMC
Yes
New York State Psychiatric Institute
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Principal Investigator: Frances R Levin, MD New York State Psychiatric Institute
New York State Psychiatric Institute
June 2012

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