Extended-release Naltrexone (Vivitrol) for the Treatment of Alcohol Dependence in Urban Primary Care: a Feasibility Study
Overview
- Phase
- Phase 4
- Intervention
- Extended release injectable naltrexone (Vivitrol)
- Conditions
- Alcohol Dependence
- Sponsor
- NYU Langone Health
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Percent of Patients Initiating Vivitrol Treatment Who Receive 3 Consecutive Monthly Vivitrol Injections
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
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.
Investigators
Marc Gourevitch
Director of General Internal Medicine
NYU Langone Health
Eligibility Criteria
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
Arms & Interventions
Extended release injectable naltrexone
Intervention: Extended release injectable naltrexone (Vivitrol)
Outcomes
Primary Outcomes
Percent of Patients Initiating Vivitrol Treatment Who Receive 3 Consecutive Monthly Vivitrol Injections
Time Frame: 4 months