Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dronabinol Treatment for Marijuana Addiction (MARINOL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00217971
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : November 1, 2011
Last Update Posted : April 24, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Frances R Levin, National Institute on Drug Abuse (NIDA)

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to determine if dronabinol decreases the symptoms of marijuana addiction and withdrawal.

Condition or disease Intervention/treatment Phase
Marijuana Abuse Drug: Dronabinol Drug: Placebo Phase 2

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of Dronabinol in the Treatment of Marijuana Addiction
Study Start Date : March 2005
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana
Drug Information available for: Dronabinol

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00217971


Locations
Layout table for location information
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
National Institute on Drug Abuse (NIDA)
Investigators
Layout table for investigator information
Principal Investigator: Frances R Levin, MD New York State Psychiatric Institute
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Frances R Levin, Director of Substance Use Disorder, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00217971    
Other Study ID Numbers: #4886-NIDA-09236-11
P50DA009236 ( U.S. NIH Grant/Contract )
P50DA009236-11 ( U.S. NIH Grant/Contract )
DPMC
First Posted: September 22, 2005    Key Record Dates
Results First Posted: November 1, 2011
Last Update Posted: April 24, 2019
Last Verified: April 2019
Keywords provided by Frances R Levin, National Institute on Drug Abuse (NIDA):
cannabis dependence
dronabinol
treatment
Additional relevant MeSH terms:
Layout table for MeSH terms
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists