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Sponsors and Collaborators: |
New York University School of Medicine Alkermes |
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Information provided by: | New York University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00620750 |
Naltrexone is an opioid antagonist with a high affinity for the mu opioid receptor. The efficacy of extended-release naltrexone (Vivitrol) as a treatment for alcohol dependence has been demonstrated in clinical trials, raising the prospect of integrating pharmacologic treatment for alcohol dependence into general medical care settings. However, the feasibility of implementing this FDA approved treatment in the front-line settings in which it is most needed has not been demonstrated. This is an open-label pilot feasibility study of implementing treatment with Vivitrol in primary care medical clinics in a safety net hospital system affiliated with an urban academic center.
Condition | Intervention | Phase |
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Alcohol Dependence |
Drug: Extended release injectable naltrexone (Vivitrol) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | Extended-Release Naltrexone (Vivitrol) for the Treatment of Alcohol Dependence in Urban Primary Care: a Feasibility Study |
Estimated Enrollment: | 72 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
NYU School of Medicine | |
New York, New York, United States, 10016 |
Principal Investigator: | Marc N Gourevitch, MD | NYU School of Medicine |
Responsible Party: | New York University School of Medicine ( Marc Gourevitch, MD ) |
Study ID Numbers: | C18816/6067/DP/US |
Study First Received: | February 11, 2008 |
Last Updated: | October 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00620750 |
Health Authority: | United States: Institutional Review Board |
Alcohol dependence |
Mental Disorders Naltrexone Alcoholism Substance-Related Disorders |
Disorders of Environmental Origin Alcohol-Related Disorders Ethanol |
Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Narcotic Antagonists |
Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions |