Back to resultsExtended-release Naltrexone for Alcohol Dependence in Primary Care
Primary Purpose
Alcohol Dependence
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Extended release injectable naltrexone (Vivitrol)
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Dependence focused on measuring Alcohol dependence
Eligibility 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
Sites / Locations
- NYU School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Extended release injectable naltrexone
Arm Description
Outcomes
Primary Outcome Measures
Percent of Patients Initiating Vivitrol Treatment Who Receive 3 Consecutive Monthly Vivitrol Injections
Secondary Outcome Measures
Full Information
NCT ID
NCT00620750
First Posted
February 11, 2008
Last Updated
August 22, 2011
Sponsor
NYU Langone Health
Collaborators
Alkermes, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00620750
Brief Title
Extended-release Naltrexone for Alcohol Dependence in Primary Care
Official Title
Extended-release Naltrexone (Vivitrol) for the Treatment of Alcohol Dependence in Urban Primary Care: a Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NYU Langone Health
Collaborators
Alkermes, Inc.
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
Keywords
Alcohol dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Extended release injectable naltrexone
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Extended release injectable naltrexone (Vivitrol)
Other Intervention Name(s)
Vivitrol
Intervention Description
Three sequential monthly injections of extended release injectable naltrexone (Vivitrol), with option to extend participation for an additional 12 months.
Primary Outcome Measure Information:
Title
Percent of Patients Initiating Vivitrol Treatment Who Receive 3 Consecutive Monthly Vivitrol Injections
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc N Gourevitch, MD
Organizational Affiliation
NYU School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20363090
Citation
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 2010 Apr 2.
Results Reference
result
PubMed Identifier
22985676
Citation
Lee JD, Grossman E, Huben L, Manseau M, McNeely J, Rotrosen J, Stevens D, Gourevitch MN. Extended-release naltrexone plus medical management alcohol treatment in primary care: findings at 15 months. J Subst Abuse Treat. 2012 Dec;43(4):458-62. doi: 10.1016/j.jsat.2012.08.012. Epub 2012 Sep 15.
Results Reference
derived
Learn more about this trial
Extended-release Naltrexone for Alcohol Dependence in Primary Care
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