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| Sponsored by: |
National Institute on Drug Abuse (NIDA) |
|---|---|
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00218517 |
Purpose
During the past 15 years, the demand for treatment for marijuana-related problems in the United States has increased nearly twofold. Selegiline is a medication currently used to treat nicotine dependence. The purpose of this study is to evaluate whether selegiline may be useful in treating individuals with marijuana dependence.
| Condition | Intervention | Phase |
|---|---|---|
|
Marijuana Abuse |
Drug: Selegiline hydrochloride Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Selegiline for Treatment of Cannabis Dependence |
| Enrollment: | 19 |
| Study Start Date: | March 2005 |
| Study Completion Date: | July 2007 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: Selegiline hydrochloride
Daily oral selegiline, 5 mg po qd x 7 days, then 5 mg po bid for 7 weeks
|
| 2: Placebo Comparator |
Drug: Placebo
Matching placebo capsules using blue 00 capsules
|
Behavioral therapy paired with drug therapy might be a more effective treatment approach to marijuana dependence than behavioral therapy alone. Selegiline is a monoamine oxidase-B inhibitor. It increases dopamine activity in parts of the brain that are involved in dependence on addictive drugs such as nicotine, cocaine, and marijuana. Selegiline has been effective in treating nicotine dependence, but has not yet been studied in treating marijuana dependent individuals. The purpose of this study is to evaluate the effectiveness of selegiline in treating marijuana dependent individuals. Specifically, this study will determine whether selegiline reduces marijuana craving and withdrawal symptoms, thus leading to reduction or abstinence in marijuana use.
Participants in this 9-week, double-blind, placebo-controlled study will be randomly assigned to receive either selegiline (10 mg/day in two 5 mg pills) or placebo. Study visits will occur twice each week. At each study visit, participants will complete self-reports and urine toxicology tests. Throughout the study, participants will receive weekly individual counseling. The counseling sessions will last 15 minutes. Reduction in marijuana use as well as the number of weeks of consecutive marijuana abstinence will be evaluated.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | NIDA ( Ivan Montoya, Program Official ) |
| Study ID Numbers: | NIDA-19246-1, R21-19246-1, DPMC |
| Study First Received: | September 16, 2005 |
| Last Updated: | July 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00218517 |
| Health Authority: | United States: Food and Drug Administration; United States: Federal Government |
|
Selegiline Mental Disorders Substance-Related Disorders Disorders of Environmental Origin Marijuana Abuse |
|
Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Therapeutic Uses Physiological Effects of Drugs Monoamine Oxidase Inhibitors Antiparkinson Agents |
Enzyme Inhibitors Central Nervous System Agents Protective Agents Neuroprotective Agents Pharmacologic Actions |
