Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2019 Jun:81:102-109.
doi: 10.1016/j.cct.2019.04.006. Epub 2019 Apr 12.

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

Mia Malone  1 , Ryan McDonald  1 , Alex Vittitow  1 , Jenny Chen  1 , Rita Obi  1 , Daniel Schatz  1 , Babak Tofighi  2 , Ann Garment  3 , Andrea Kermack  4 , Keith Goldfeld  1 , Heather Gold  1 , Eugene Laska  5 , John Rotrosen  5 , Joshua D Lee  6
Affiliations
Randomized Controlled Trial

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

Mia Malone et al. Contemp Clin Trials. 2019 Jun.

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.

PubMed Disclaimer

Conflict of interest statement

Conflicts of interest

We wish to confirm that there are no known conflicts of interest associated with this publication and there has been no significant financial support for this work that could have influenced its outcome.

Figures

Fig. 1.
Fig. 1.
Study flow.
See this image and copyright information in PMC

References

    1. Substance Abuse and Mental Health Services Administration, Key substance use and mental health indicators in the United States: Results from the 2016 National Survey on Drug Use and Health, HHS Publication No. SMA 17–05==5044, NSDUH Series H-52, 2017. https://www.samhsa.gov/data/, Accessed date: 4 June 2018.
    1. Mann K, Schafer DR, Langle G, Ackermann K, Croissant B, The long-term course of alcoholism, 5, 10 and 16 years after treatment, Addict. 100 (6) (2005) 797–805, 10.1111/j.1360-0443.2005.01065.x. - DOI - PubMed
    1. Rivara FP, Garrison MM, Ebel B, McCarty CA, Christakis DA, Mortality attributable to harmful drinking in the United States, 2000, J. Stud. Alcohol 65 (4) (2004) 530–536, 10.15288/jsa.2004.65.530. - DOI - PubMed
    1. Hasin DS, Dasin FS, Ogburn E, Grant BF, Prevalence, correlates, disability, and comorbidity of DSM-IV alcohol abuse and dependence in the United States: results from the National Epidemiologic Survey on Alcohol and Related Conditions, Arch. Gen. Psychiatry 64 (7) (2007) 830–842, 10.1001/archpsyc.64.7.830. - DOI - PubMed
    1. Mertens JR, Weisner C, Ray GT, Fireman B, Walsh K, Hazardous drinkers and drug users in HMO primary care: prevalence, medical conditions, and costs, Alcohol. Clin. Exp. Res 29 (6) (2005) 989–998, 10.1097/01.ALC.0000167958.68586.3D. - DOI - PubMed

Publication types