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Extended-release Naltrexone for Alcohol Dependence in Primary Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00620750
Recruitment Status : Completed
First Posted : February 21, 2008
Results First Posted : September 27, 2011
Last Update Posted : September 27, 2011
Information provided by (Responsible Party):

February 11, 2008
February 21, 2008
June 9, 2011
September 27, 2011
September 27, 2011
July 2007
November 2008   (Final data collection date for primary outcome measure)
Percent of Patients Initiating Vivitrol Treatment Who Receive 3 Consecutive Monthly Vivitrol Injections [ Time Frame: 4 months ]
Same as current
Complete list of historical versions of study NCT00620750 on ClinicalTrials.gov Archive Site
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Extended-release Naltrexone for Alcohol Dependence in Primary Care
Extended-release Naltrexone (Vivitrol) for the Treatment of Alcohol Dependence in Urban Primary Care: a Feasibility Study
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.
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Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Alcohol Dependence
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.
Other Name: Vivitrol
Experimental: Extended release injectable naltrexone
Intervention: Drug: Extended release injectable naltrexone (Vivitrol)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
February 2010
November 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Marc Gourevitch, New York University School of Medicine
New York University School of Medicine
Alkermes, Inc.
Principal Investigator: Marc N Gourevitch, MD NYU School of Medicine
New York University School of Medicine
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP