This study seeks to address the clinical dilemma of how much more effective, if any, a newer, more expensive form of naltrexone (Extended-Release Naltrexone, XR- NTX) is compared to the older, cheaper, oral form (O-NTX), when used in a simple, primary care-based, Medical Management protocol, and using a comparative effectiveness, cost-effectiveness, pragmatic randomized controlled trial design. If the treatment of alcohol disorders is to meaningfully expand in the era of the medical home, addiction parity, and health insurance reform, primary care physicians and payers must be convinced that effective, simple-to-use, pharmacotherapies are worth prescribing. This study will consist of a pragmatic, randomized, open-label treatment trial of 24 weeks of XR-NTX vs. O-NTX Medical Management delivered in primary care. N=234 adults >18yo with alcohol dependence will be recruited from the community to treatment at two New York City adult primary care sites in lower Manhattan, Bellevue Hospital Center and Gouverneur Diagnostic and Treatment Center. The primary outcome will be a good clinical outcome of abstinence or moderate drinking during the final 20 weeks (weeks 5-24) of a 24 week treatment trial. Cost effectiveness analysis will include long- term models of treatment impact on patient, health system, and societal costs. Secondary outcomes include other standard calendar and count measures of alcohol intake (drinks/day, days abstinent, time to first heavy drinking day), treatment retention as a continuous variable, biomarkers including GGT and CDT, and the association of mu opioid receptor Asp40 functional allele status with XR-NTX treatment effectiveness.

Public Health Relevance

This proposal is a real-world evaluation of the effectiveness of a newer form of naltrexone, injectable extended-release naltrexone, for primary care alcohol treatment. Comparative and cost effectiveness data from this study will inform the integration of alcohol medical management treatment into the patient-centered medical home, and possibly expand alcohol pharmacotherapies to persons not otherwise accessing specialty treatment.

National Institute of Health (NIH)
Research Project (R01)
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Biomedical Research Review Subcommittee (AA)
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Fertig, Joanne
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New York University
Internal Medicine/Medicine
Schools of Medicine
New York
United States
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