Patient characteristics associated with buprenorphine/naloxone treatment outcome for prescription opioid dependence: Results from a multisite study

Abstract

Background: Prescription opioid dependence is a growing problem, but little research exists on its treatment, including patient characteristics that predict treatment outcome.

Methods: A secondary analysis of data from a large multisite, randomized clinical trial, the National Drug Abuse Treatment Clinical Trials Network Prescription Opioid Addiction Treatment Study (POATS) was undertaken to examine baseline patient characteristics (N=360) associated with success during 12-week buprenorphine/naloxone treatment for prescription opioid dependence. Baseline predictor variables included self-reported demographic and opioid use history information, diagnoses assessed via the Composite International Diagnostic Interview, and historical opioid use and related information from the Pain And Opiate Analgesic Use History.

Results: In bivariate analyses, pre-treatment characteristics associated with successful opioid use outcome included older age, past-year or lifetime diagnosis of major depressive disorder, initially obtaining opioids with a medical prescription to relieve pain, having only used opioids by swallowing or sublingual administration, never having used heroin, using an opioid other than extended-release oxycodone most frequently, and no prior opioid dependence treatment. In multivariate analysis, age, lifetime major depressive disorder, having only used opioids by swallowing or sublingual administration, and receiving no prior opioid dependence treatment remained as significant predictors of successful outcome.

Conclusions: This is the first study to examine characteristics associated with treatment outcome in patients dependent exclusively on prescription opioids. Characteristics associated with successful outcome after 12 weeks of buprenorphine/naloxone treatment include some that have previously been found to predict heroin-dependent patients' response to methadone treatment and some specific to prescription opioid-dependent patients receiving buprenorphine/naloxone.

Trial registration: ClinicalTrials.gov NCT00316277.

Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Figures

Figure 1. Study Design

1Stratified by presence or absence of a history of heroin use and current chronic pain 2Standard Medical Management; phase 1, week 1: 2 visits; weeks 2 to 4: 1 visit/wk; and weeks 5 to 8: biweekly visits 3Opioid dependence counseling (ODC); phase 1, Weeks 1 to 4: 2 visits/wk; Weeks 5 to 8: biweekly visits 4Buprenorphine-naloxone (bup/nx) dose: 8 to 32 mg/d 5Phase 1 primary endpoint: completion of week 12 with self-reported opioid use on no more than 4 days in a month; absence of 2 consecutive opioid-positive urine test results; no additional substance use disorder treatment (other than self-help); and no more than 1 missing urine sample 6Stratified by phase 1 counseling condition, that is, SMM or SMM+ODC 7SMM; phase 2, week 1: 2 visits; and weeks 2 to 16: 1 visit/wk 8ODC; phase 2, Weeks 1 to 6: 2 visits/wk; and weeks 7 to 12: 1 visit/wk 9Phase 2 primary endpoint: abstinent from opioids during week 12 (the final week of bup/nx stabilization) and during at least 2 of the previous 3 weeks (weeks 9-11) 10Phase 2 secondary endpoint: abstinent from opioids during week 24 and during at least 2 of the previous 3 weeks (weeks 21-23) This figure is reprinted with permission of the American Medical Association (license number 3011491044721) from “Adjunctive counseling during brief and extended buprenorphine-naloxone treatment for prescription opioid dependence,” Arch. Gen. Psychiatry. 2011;68(12):1238-1246. Weiss, Potter, Fiellin, Byrne, Connery, Dickinson, et al.