Extended-Release vs. Oral Naltrexone Alcohol Treatment in Primary Care
Status:
Completed
Trial end date:
2018-10-03
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
New York University School of Medicine NYU Langone Health