Extended-release Naltrexone for Alcohol Dependence in Primary Care

Phase 4

Completed

• Conditions: Alcohol Dependence
• Interventions: Drug: Extended release injectable naltrexone (Vivitrol)

• Registration Number: NCT00620750
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2008-02-11
• Study First Submitted QC: 2008-02-11
• Study First Posted: 2008-02-21
• Primary Completion: 2008-11
• Study Completion: 2010-02
• Results First Submitted: 2011-06-09
• Status Verified: 2011-08
• Results First Submitted QC: 2011-08-22
• Last Update Submitted: 2011-08-22
• Results First Posted: 2011-09-27
• Last Update Posted: 2011-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Extended release injectable naltrexone	Extended release injectable naltrexone (Vivitrol)	-

Primary Outcome Measures

Name	Time	Method
Percent of Patients Initiating Vivitrol Treatment Who Receive 3 Consecutive Monthly Vivitrol Injections	4 months

Trial Locations

Locations (1)

NYU School of Medicine; 🇺🇸 New York, New York, United States