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

Alcohol Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00461890
• Other study ID #: Syracuse VA IRB #00364
• Status: Terminated
• Phase: Phase 4
• First received: April 13, 2007
• Last updated: October 21, 2011
• Start date: October 2006
• Est. completion date: December 2007

Study information

• Verified date: October 2011
• Source: State University of New York - Upstate Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism
• Veterans

Intervention

Drug:
• Injectable Naltrexone

Locations

Country	Name	City	State
United States	Syracuse VAMC	Syracuse	New York

Sponsors (2)

Lead Sponsor	Collaborator
State University of New York - Upstate Medical University	VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcomes: Feasibility of an injectable naltrexone study in the primary care setting.
Secondary	Secondary Outcome: Effectiveness of long-acting injectable naltrexone in primary care versus in the chemical dependence clinic.