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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

April 13, 2007
October 21, 2011
October 2006
December 2007   (final data collection date for primary outcome measure)
Primary Outcomes: Feasibility of an injectable naltrexone study in the primary care setting.
Same as current
Complete list of historical versions of study NCT00461890 on ClinicalTrials.gov Archive Site
Secondary Outcome: Effectiveness of long-acting injectable naltrexone in primary care versus in the chemical dependence clinic.
Same as current
Not Provided
Not Provided
 
Long-Acting Injectable Naltrexone Treatment of Alcohol Dependence in Primary Care vs. in Specialized Chemical Dependence Treatment: A Pilot Trial
Long-Acting Injectable Naltrexone Treatment of Alcohol Dependence in Primary Care vs. in Specialized Chemical Dependence Treatment: A Pilot Trial

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Alcohol Dependence
  • Veterans
Drug: Injectable Naltrexone
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
20
December 2007
December 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 69 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00461890
Syracuse VA IRB #00364
Not Provided
Steven Batki, M.D., State University of New York - Upstate Medical University
State University of New York - Upstate Medical University
Department of Veterans Affairs
Principal Investigator: Steven L Batki, M.D. Executive Director VA Center for Integrated Healthcare, Syracuse VA Medical Center
State University of New York - Upstate Medical University
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP