drugset / Trial / NCT00620750
Extended-release Naltrexone for Alcohol Dependence in Primary Care
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
Publications
- 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.
- Lee JD, Grossman E, Huben L, Manseau M, McNeely J, Rotrosen J, Stevens D, Gourevitch MN. Extended-release naltrexone plus medical management alcohol treatment in primary care: findings at 15 months. J Subst Abuse Treat. 2012 Dec;43(4):458-62. doi: 10.1016/j.jsat.2012.08.012. Epub 2012 Sep 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Naltrexone | Small molecule | 380 mg | Intramuscular |