- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00217971
Dronabinol Treatment for Marijuana Addiction (MARINOL)
A Randomized, Double-Blind, Placebo-Controlled Study of Dronabinol in the Treatment of Marijuana Addiction
Study Overview
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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New York
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New York, New York, United States, 10032
- Research Foundation for Mental Hygiene, Inc.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Dronabinol
Dronabinol: 20mg bid for a daily maximum dose of 40mg.
|
Dronabinol
Other Names:
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Placebo Comparator: Placebo
placebo
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placebo
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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weeks 7 and 8
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: frances r levin, md, New York State Psychiatric Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Marijuana Abuse
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Psychotropic Drugs
- Hallucinogens
- Cannabinoid Receptor Agonists
- Cannabinoid Receptor Modulators
- Dronabinol
Other Study ID Numbers
- #4886-NIDA-09236-11
- DPMC (Other Identifier: NIDA)
- P50DA009236 (U.S. NIH Grant/Contract)
- P50DA009236-11 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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