Extended-Release Naltrexone for Alcohol Dependence in Primary Care - Full Text View

Sponsors and Collaborators:	New York University School of Medicine Alkermes
Information provided by:	New York University School of Medicine
ClinicalTrials.gov Identifier:	NCT00620750

Purpose

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 FDA 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.

Condition	Intervention	Phase
Alcohol Dependence	Drug: Extended release injectable naltrexone (Vivitrol)	Phase IV

MedlinePlus related topics: Alcoholism

Drug Information available for: Naltrexone Naltrexone hydrochloride Ethanol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
Official Title:	Extended-Release Naltrexone (Vivitrol) for the Treatment of Alcohol Dependence in Urban Primary Care: a Feasibility Study

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:

Percent of patients initiating Vivitrol treatment who receive 3 consecutive monthly Vivitrol injections [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	72
Study Start Date:	July 2007
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Three sequential monthly injections of extended release injectable naltrexone (Vivitrol), with option to extend participation for an additional 12 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Current alcohol dependence
Age 18 or older
English or Spanish-speaking
Without untreated severe mental illness
Liver enzymes (ALT and AST) ≤ 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00620750

Locations

United States, New York
NYU School of Medicine
New York, New York, United States, 10016

Sponsors and Collaborators

New York University School of Medicine

Alkermes

Investigators

Principal Investigator:

Marc N Gourevitch, MD

NYU School of Medicine

More Information

Responsible Party:	New York University School of Medicine ( Marc Gourevitch, MD )
Study ID Numbers:	C18816/6067/DP/US
Study First Received:	February 11, 2008
Last Updated:	October 30, 2008
ClinicalTrials.gov Identifier:	NCT00620750
Health Authority:	United States: Institutional Review Board

Keywords provided by New York University School of Medicine:

Alcohol dependence

Study placed in the following topic categories:

Mental Disorders
Naltrexone
Alcoholism
Substance-Related Disorders

Disorders of Environmental Origin
Alcohol-Related Disorders
Ethanol

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Narcotic Antagonists

Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009