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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
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Alcohol Dependence Drug: Extended release injectable naltrexone (Vivitrol) Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Extended-release Naltrexone (Vivitrol) for the Treatment of Alcohol Dependence in Urban Primary Care: a Feasibility Study
Study Start Date : July 2007
Primary Completion Date : November 2008
Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Extended release injectable naltrexone 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


Outcome Measures

Primary Outcome Measures :
  1. Percent of Patients Initiating Vivitrol Treatment Who Receive 3 Consecutive Monthly Vivitrol Injections [ Time Frame: 4 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 (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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, Inc.
Investigators
Principal Investigator: Marc N Gourevitch, MD NYU School of Medicine
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marc Gourevitch, Director of General Internal Medicine, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00620750     History of Changes
Other Study ID Numbers: C18816/6067/DP/US
First Posted: February 21, 2008    Key Record Dates
Results First Posted: September 27, 2011
Last Update Posted: September 27, 2011
Last Verified: August 2011

Keywords provided by Marc Gourevitch, New York University School of Medicine:
Alcohol dependence

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Naltrexone
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Narcotic Antagonists
Sensory System Agents
Peripheral Nervous System Agents