Long-Acting Injectable Naltrexone Treatment of Alcohol Dependence in Primary Care vs. in Specialized Chemical Dependence Treatment: A Pilot Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alcohol Dependence Veterans

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Injectable Naltrexone

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Steven Batki, M.D.

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Steven L Batki, M.D.

Role: PRINCIPAL_INVESTIGATOR

Executive Director VA Center for Integrated Healthcare, Syracuse VA Medical Center

Locations

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Syracuse VAMC

Syracuse, New York, United States

Site Status

Countries

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United States

Other Identifiers

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Syracuse VA IRB #00364

Identifier Type: -

Identifier Source: org_study_id