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

This study has been terminated.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Steven Batki, M.D., State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:
NCT00461890
First received: April 13, 2007
Last updated: October 21, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Alcohol Dependence
Veterans
Drug: Injectable Naltrexone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-Acting Injectable Naltrexone Treatment of Alcohol Dependence in Primary Care vs. in Specialized Chemical Dependence Treatment: A Pilot Trial

Resource links provided by NLM:


Further study details as provided by State University of New York - Upstate Medical University:

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.

Estimated Enrollment: 20
Study Start Date: October 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00461890

Locations
United States, New York
Syracuse VAMC
Syracuse, New York, United States, 13210
Sponsors and Collaborators
State University of New York - Upstate Medical University
Investigators
Principal Investigator: Steven L Batki, M.D. Executive Director VA Center for Integrated Healthcare, Syracuse VA Medical Center
  More Information

No publications provided

Responsible Party: Steven Batki, M.D., Professor, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT00461890     History of Changes
Other Study ID Numbers: Syracuse VA IRB #00364
Study First Received: April 13, 2007
Last Updated: October 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by State University of New York - Upstate Medical University:
Alcohol
Veterans
Primary Care
Naltrexone

Additional relevant MeSH terms:
Alcoholism
Substance-Related Disorders
Alcohol-Related 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 April 14, 2014