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

Contemp Clin Trials. 2019 Jun;81:102-109. doi: 10.1016/j.cct.2019.04.006. Epub 2019 Apr 12.

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.

Keywords: Alcohol dependence; Alcohol use disorder; Extended-release naltrexone; Medical management; Naltrexone; Primary care treatment.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

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

Substances

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