Extended-release vs. oral naltrexone for alcohol dependence treatment in primary care (XON).

Abstract

BACKGROUND:

Extended-release naltrexone (XR-NTX, Vivitrol®) and daily oral naltrexone tablets (O-NTX) are FDA-approved mu opioid receptor antagonist medications for alcohol dependence treatment. Despite the efficacy of O-NTX, non-adherence and poor treatment retention have limited its adoption into primary care. XR-NTX is a once-a-month injectable formulation that offers a potentially more effective treatment option in reducing alcohol consumption and heavy drinking episodes among persons with alcohol use disorders.

METHODS:

This pragmatic, open-label, randomized controlled trial examines the effectiveness of XR-NTX vs. O-NTX in producing a Good Clinical Outcome, defined as abstinence or moderate drinking (<2 drinks/day, men; <1 drink/day, women; and < 2 heavy drinking occasions/month) during the final 20 of 24 weeks of primary care-based Medical Management treatment for alcohol dependence. Secondary aims will estimate the cost effectiveness of XR-NTX vs. O-NTX, in conjunction with primary-care based Medical Management for both groups, and patient-level characteristics associated with effectiveness in both arms. Alcohol dependent persons are recruited from the community into treatment in a New York City public hospital primary care setting (Bellevue Hospital Center) for 24 weeks of either XR-NTX (n = 117) or O-NTX (n = 120).

RESULTS:

We describe the rationale, specific aims, design, and recruitment results to date. Alternative design considerations and secondary aims and outcomes are reported.

CONCLUSIONS:

XR-NTX treatment in a primary care setting is potentially more efficacious, feasible, and cost-effective than oral naltrexone when treating community-dwelling persons with alcohol use disorders. This study will estimate XR-NTX's treatment and cost effectiveness relative to oral naltrexone.

• Authors: Mia Malone, Ryan McDonald, Alex Vittitow, Jenny Chen, Rita Obi, Daniel Schatz, Babak Tofighi, Ann Garment, Andrea Kermack, Keith Goldfeld, Heather Gold, Eugene Laska, John Rotrosen, Joshua D Lee
• Journal: Contemporary clinical trials (Contemp Clin Trials) Vol. 81 Pg. 102-109 (06 2019) ISSN: 1559-2030 [Electronic] United States
• PMID: 30986535 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural)
• Copyright: Copyright © 2019. Published by Elsevier Inc.

Chemical References

• Delayed-Action Preparations
• Narcotic Antagonists
• vivitrol
• Naltrexone

Topics

• Adult
• Alcoholism (drug therapy)
• Cost-Benefit Analysis
• Delayed-Action Preparations
• Humans
• Injections, Intramuscular
• Middle Aged
• Models, Econometric
• Naltrexone (administration & dosage, economics, therapeutic use)
• Narcotic Antagonists (administration & dosage, economics, therapeutic use)
• Primary Health Care
• Socioeconomic Factors