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: March 30, 2015
Last verified: March 2015

September 16, 2005
March 30, 2015
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:

  • men and women between the ages of 18-60
  • 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
  • Individuals must be capable of giving informed consent and capable of complying with study procedures.
  • Women of child-bearing age will be included in the study provided that they are not pregnant, based on the results of a blood pregnancy test drawn at the time of screening. They must also agree to use a method of contraception with proven efficacy and agree not to become pregnant during the study. To confirm this, blood pregnancy tests will be repeated monthly. Women will be provided a full explanation of the potential dangers of pregnancy while on the study medication. If a woman becomes pregnant, the study medication will be discontinued.

Exclusion Criteria:

  • Meets criteria for current psychiatric disorder requiring psychiatric intervention. Disorders that are stable on psychotherapy or pharmacotherapy will not be exclusionary. Individuals will be permitted to take prescribed zolpidem and zaleplon if there is no evidence of dependence on these substances.
  • 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
  • Individuals who have exhibited suicidal or homicidal behavior within the past two years or who have current active suicidal ideation.
  • Individuals with coronary vascular disease as indicated by history of abnormal ECG or history of cardiac symptoms.
  • Unstable physical disorder which might make participation hazardous such as uncontrolled hypertension (SBP > 150, DBP> 90, or HR > 100 when sitting quietly), acute hepatitis (patients with chronic mildly elevated transaminases < 2-3X upper limit of normal are acceptable), or medically unstable diabetes.
  • Subjects in professions in which even mild intoxication would be hazardous (e.g., police officer, bus driver, firefighter).
  • Individuals who are court-mandated to treatment.
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
March 2015

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