drugset / Trial / NCT00620750

Extended-release Naltrexone for Alcohol Dependence in Primary Care

NCT00620750

Phase 4 Completed 72 enrolled NYU Langone Health Alkermes, Inc. · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2007-07
Primary completion
2008-11
Completion
2010-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Naltrexone Small molecule 380 mg Intramuscular

Indications