Extended-Release vs. Oral Naltrexone Alcohol Treatment in Primary Care

• Status: Completed
• Trial end date: 2018-10-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Treatments: Ethanol; Naltrexone

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).