Extended-release Naltrexone for Alcohol Dependence in Primary Care

Alcohol Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00620750
• Other study ID #: C18816/6067/DP/US
• Status: Completed
• Phase: Phase 4
• First received: February 11, 2008
• Last updated: August 22, 2011
• Start date: July 2007
• Est. completion date: February 2010

Study information

• Verified date: August 2011
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: February 2010
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

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.

Locations

Country	Name	City	State
United States	NYU School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	Alkermes, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Patients Initiating Vivitrol Treatment Who Receive 3 Consecutive Monthly Vivitrol Injections		4 months	No