NCT00620750

Extended-release Naltrexone for Alcohol Dependence in Primary Care

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alcohol Dependence

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-07-01
• Primary completion: 2008-11-01
• Completion: 2010-02-01
• First posted: 2008-02-21
• Last updated: 2011-09-27
• Results posted: 2011-09-27

Locations

1 site across 1 country: United States