Extended-release Naltrexone for Alcohol Dependence in Primary Care

This study has been completed.
Sponsor:
Collaborator:
Alkermes, Inc.
Information provided by (Responsible Party):
Marc Gourevitch, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00620750
First received: February 11, 2008
Last updated: August 22, 2011
Last verified: August 2011
  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 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 Intervention Phase
Alcohol Dependence
Drug: Extended release injectable naltrexone (Vivitrol)
Phase 4

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

Resource links provided by NLM:


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 ]

Enrollment: 72
Study Start Date: July 2007
Study Completion Date: February 2010
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Inc.
Investigators
Principal Investigator: Marc N Gourevitch, MD NYU School of Medicine
  More Information

Publications:
Additional 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
Study First Received: February 11, 2008
Results First Received: June 9, 2011
Last Updated: August 22, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 16, 2014