Extended-release Naltrexone for Alcohol Dependence in Primary Care

Overview

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 United States Food and Drug Administration 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.

Full Title of Study: “Extended-release Naltrexone (Vivitrol) for the Treatment of Alcohol Dependence in Urban Primary Care: a Feasibility Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2008

Interventions

  • Drug: Extended release injectable naltrexone (Vivitrol)
    • Three sequential monthly injections of extended release injectable naltrexone (Vivitrol), with option to extend participation for an additional 12 months.

Arms, Groups and Cohorts

  • Experimental: Extended release injectable naltrexone

Clinical Trial Outcome Measures

Primary Measures

  • Percent of Patients Initiating Vivitrol Treatment Who Receive 3 Consecutive Monthly Vivitrol Injections
    • Time Frame: 4 months

Participating in This Clinical Trial

Inclusion Criteria

  • Current alcohol dependence – Age 18 or older – English or Spanish-speaking – Without untreated severe mental illness – Liver enzymes (alanine aminotransferase and aspartate aminotransferase) ≤ 3x normal – Kept 2 of last 3 clinic primary care appointments and/or has a working telephone number at which can be contacted directly – Either a) currently abstinent (e.g., referred from an inpatient 'detox' setting) or b) with the ability, in the clinician's judgment, to achieve and maintain abstinence – If female of child-bearing potential, must be using adequate contraception – Able to understand study procedures Exclusion Criteria:

  • Currently opioid dependent or requiring ongoing treatment with opioids for any indication

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • NYU Langone Health
  • Collaborator
    • Alkermes, Inc.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Marc Gourevitch, Director of General Internal Medicine – NYU Langone Health
  • Overall Official(s)
    • Marc N Gourevitch, MD, Principal Investigator, NYU School of Medicine

Citations Reporting on Results

Lee JD, Grossman E, DiRocco D, Truncali A, Hanley K, Stevens D, Rotrosen J, Gourevitch MN. Extended-release naltrexone for treatment of alcohol dependence in primary care. J Subst Abuse Treat. 2010 Jul;39(1):14-21. doi: 10.1016/j.jsat.2010.03.005. Epub 2010 Apr 2.

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