Long-Acting Injectable Naltrexone Treatment of Alcohol Dependence in Primary Care vs. in Specialized Chemical Dependence Treatment: A Pilot Trial
Information source: State University of New York - Upstate Medical University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alcohol Dependence; Veterans
Intervention: Injectable Naltrexone (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: State University of New York - Upstate Medical University Official(s) and/or principal investigator(s): Steven L Batki, M.D., Principal Investigator, Affiliation: Executive Director VA Center for Integrated Healthcare, Syracuse VA Medical Center
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.
Clinical Details
Official title: Long-Acting Injectable Naltrexone Treatment of Alcohol Dependence in Primary Care vs. in Specialized Chemical Dependence Treatment: A Pilot Trial
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Primary Outcomes: Feasibility of an injectable naltrexone study in the primary care setting.
Secondary outcome: Secondary Outcome: Effectiveness of long-acting injectable naltrexone in primary care versus in the chemical dependence clinic.
Eligibility
Minimum age: 18 Years.
Maximum age: 69 Years.
Gender(s): Both.
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
Locations and Contacts
Syracuse VAMC, Syracuse, New York 13210, United States
Additional Information
Starting date: October 2006
Last updated: October 21, 2011
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