Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
156 participants
INTERVENTIONAL
2005-03-31
2009-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Dronabinol
Dronabinol: 20mg bid for a daily maximum dose of 40mg.
Dronabinol
Dronabinol
Placebo
placebo
Placebo
placebo
Interventions
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Dronabinol
Dronabinol
Placebo
placebo
Other Intervention Names
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Eligibility Criteria
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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
* 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
* 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.
18 Years
60 Years
ALL
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
New York State Psychiatric Institute
OTHER
Responsible Party
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Frances R Levin
Director of Substance Use Disorder
Principal Investigators
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Frances R Levin, MD
Role: PRINCIPAL_INVESTIGATOR
New York State Psychiatric Institute
Locations
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Research Foundation for Mental Hygiene, Inc.
New York, New York, United States
Countries
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Related Links
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Click here for the Substance Treatment and Abuse Research Service (STARS) website
Other Identifiers
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