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
  Purpose

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


Condition Intervention Phase
Marijuana Abuse
Drug: Dronabinol
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of Dronabinol in the Treatment of Marijuana Addiction

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • 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.


Enrollment: 156
Study Start Date: March 2005
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dronabinol
Dronabinol: 20mg bid for a daily maximum dose of 40mg.
Drug: Dronabinol
Dronabinol
Other Name: Marinol
Placebo Comparator: Placebo
placebo
Drug: Placebo
placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00217971

Locations
United States, New York
Research Foundation for Mental Hygiene, Inc.
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Frances R Levin, MD New York State Psychiatric Institute
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00217971     History of Changes
Other Study ID Numbers: #4886-NIDA-09236-11, P50DA009236, P50DA009236-11, DPMC
Study First Received: September 16, 2005
Results First Received: September 13, 2011
Last Updated: June 28, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Mental Disorders
Tetrahydrocannabinol
Hallucinogens
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on April 16, 2014