Back to resultsLong-Acting Injectable Naltrexone Treatment of Alcohol Dependence in Primary Care vs. in Specialized Chemical Dependence Treatment: A Pilot Trial
Primary Purpose
Alcohol Dependence, Veterans
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Injectable Naltrexone
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Dependence focused on measuring Alcohol, Veterans, Primary Care, Naltrexone
Eligibility Criteria
Inclusion Criteria:
- Participants must be males or non-pregnant females between the ages of 18 and 69 who are receiving their primary medical care at the Syracuse VAMC.
- Participants must meet DSM-IV diagnostic criteria for current alcohol dependence.
- Participants must report drinking within the thirty days prior to study entry.
- Participants must receive approval from their primary care provider for study participation.
- Participants must be willing to consider accepting at least one of the two treatment conditions.
Exclusion Criteria:
- Participants with a current DSM-IV diagnosis of current opioid abuse or dependence, or in opioid withdrawal
- AST level is greater than 3 times the upper limit of the normal range
- Participants with a medical condition requiring opioid medication or a severe allergy to naltrexone
- Participants who received outpatient treatment at the Syracuse VA Chemical Dependence Clinic in the past 90 days
- Any unstable medical or psychiatric conditions in the judgment of the principal investigator or the participants primary care provider
Sites / Locations
- Syracuse VAMC
Outcomes
Primary Outcome Measures
Primary Outcomes: Feasibility of an injectable naltrexone study in the primary care setting.
Secondary Outcome Measures
Secondary Outcome: Effectiveness of long-acting injectable naltrexone in primary care versus in the chemical dependence clinic.
Full Information
NCT ID
NCT00461890
First Posted
April 13, 2007
Last Updated
October 21, 2011
Sponsor
State University of New York - Upstate Medical University
Collaborators
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00461890
Brief Title
Long-Acting Injectable Naltrexone Treatment of Alcohol Dependence in Primary Care vs. in Specialized Chemical Dependence Treatment: A Pilot Trial
Official Title
Long-Acting Injectable Naltrexone Treatment of Alcohol Dependence in Primary Care vs. in Specialized Chemical Dependence Treatment: A Pilot Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Terminated
Study Start Date
October 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York - Upstate Medical University
Collaborators
US Department of Veterans Affairs
4. Oversight
5. Study Description
Brief Summary
The goal of the proposed project is to improve the primary care treatment of veterans with alcohol dependence. Alcohol dependence is a common behavioral health problem among veterans treated in VA primary care clinics. However, assessment and treatment of alcohol dependence in primary care remains problematic. Assessment of veterans with positive alcohol use screens may not always be completed and referrals to specialty care may not always be made. Moreover, the use of medications for alcohol dependence among veterans is rare, despite VA treatment guidelines that recommend such use. Finally, when medications are prescribed, patients may have difficulties with adherence.
The primary aim of this study is to assess the feasibility of long-acting injectable naltrexone provided through primary care (LAN/PC) versus long-acting injectable naltrexone in the specialized chemical dependence clinic (LAN/CDC). The secondary aim is to obtain preliminary assessments of the relative effectiveness of long-acting injectable naltrexone in primary care versus in the chemical dependence clinic.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence, Veterans
Keywords
Alcohol, Veterans, Primary Care, Naltrexone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Injectable Naltrexone
Primary Outcome Measure Information:
Title
Primary Outcomes: Feasibility of an injectable naltrexone study in the primary care setting.
Secondary Outcome Measure Information:
Title
Secondary Outcome: Effectiveness of long-acting injectable naltrexone in primary care versus in the chemical dependence clinic.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participants must be males or non-pregnant females between the ages of 18 and 69 who are receiving their primary medical care at the Syracuse VAMC.
Participants must meet DSM-IV diagnostic criteria for current alcohol dependence.
Participants must report drinking within the thirty days prior to study entry.
Participants must receive approval from their primary care provider for study participation.
Participants must be willing to consider accepting at least one of the two treatment conditions.
Exclusion Criteria:
Participants with a current DSM-IV diagnosis of current opioid abuse or dependence, or in opioid withdrawal
AST level is greater than 3 times the upper limit of the normal range
Participants with a medical condition requiring opioid medication or a severe allergy to naltrexone
Participants who received outpatient treatment at the Syracuse VA Chemical Dependence Clinic in the past 90 days
Any unstable medical or psychiatric conditions in the judgment of the principal investigator or the participants primary care provider
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven L Batki, M.D.
Organizational Affiliation
Executive Director VA Center for Integrated Healthcare, Syracuse VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Syracuse VAMC
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Long-Acting Injectable Naltrexone Treatment of Alcohol Dependence in Primary Care vs. in Specialized Chemical Dependence Treatment: A Pilot Trial
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