Extended-Release vs. Oral Naltrexone Alcohol Treatment in Primary Care
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Intervention: XR-NTX (Extended-Release Naltrexone); Oral Naltrexone (O-NTX)
Intervention description: 380mg (4cc) XR-NTX administered by IM injection 1x/month for 6 months.; 50mg pill form of naltrexone taken 1x/day for 6 months.
Intervention MeSH terms: Naltrexone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 237.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Naltrexone; Extended-release naltrexone; Oral naltrexone; Vivitrol; XR-NTX; alcohol dependence; primary care; Medical Management

Summary:

      The proposed study is a pragmatic, randomized, open-label clinical trial of 24 weeks of
      XR-NTX vs. O-NTX using a COMBINE-adapted Medical Management primary care treatment model. 237
      adults >18yo with alcohol dependence will be recruited from the community into treatment in
      public sector primary care settings. The primary outcome which powers this study is a
      dichotomous good clinical outcome defined by abstinence or moderate drinking, and as measured
      by the Timeline Follow-back and analyzed using an intention-to-treat approach among all
      randomized participants. Secondary outcomes include the incremental cost effectiveness of the
      two arms, differences between arms by continuous measures of alcohol intake (drinks/day, %
      days abstinent, time to first heavy drinking day, bio-markers), and the exploratory analysis
      of factors possibly associated with effectiveness, including gender, prior treatment
      abstinence, and mu opioid receptor (OPRM1) genotypes.

      Specific Aim 1: Treatment Effectiveness. To evaluate the effectiveness of extended-release
      naltrexone (XR-NTX) vs. oral naltrexone (O-NTX) in producing a primary good clinical outcome,
      defined as abstinence or moderate drinking (≤2 drinks/day, men; ≤1 drink/day,women; and ≤2
      heavy drinking occasions/month), during the final 20 of 24 weeks of primary care-based
      Medical Management for alcohol dependence. Hypothesis: The rate of this good clinical outcome
      will be approximately twice as great among participants receiving XR-NTX compared with those
      receiving O-NTX.

      Specific Aim 2: Cost Effectiveness. To estimate the incremental cost effectiveness of XR-NTX
      vs. O-NTX,both in conjunction with primary care-based Medical Management. Hypothesis: XR-NTX
      treatment will be more cost effective than O-NTX.

      Specific Aim 3: Patient-Level Predictors of Effectiveness. To identify patient-level
      characteristics associated with effectiveness in both arms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults, age ≥18 y.o.

          -  English- or Spanish- speaking and able to understand study procedures and provide full
             consent.

          -  DSM IV diagnosis of alcohol dependence as determined by study physician and DSM IV
             checklist.

          -  Endorses goal of abstinence, and is able to achieve alcohol abstinence without
             inpatient detoxification, per study physician.

        Exclusion Criteria:

          -  Current opioid dependence and/or positive urine toxicology for extended opioids.

          -  Pregnancy or female planning conception.

          -  Allergy to naltrexone or the PGL XR-NTX formulation or diluent.

          -  Severe liver disease, liver failure, or liver function test levels greater than three
             times normal.

          -  Other severe, untreated or uncontrolled medical illness (e.g., severe heart failure or
             dementia).