Adjunctive Counseling During Brief and Extended Buprenorphine-Naloxone Treatment for Prescription Opioid Dependence

Abstract

Context No randomized trials have examined treatments for prescription opioid dependence, despite its increasing prevalence. Objective To evaluate the efficacy of brief and extended buprenorphine-naloxone treatment, with different counseling intensities, for patients dependent upon prescription opioids. Setting, Participants 653 treatment-seeking outpatients dependent on prescription opioids, at 10 U.S. sites from June 2006-July 2009. Design Multi-site, randomized clinical trial, using a two-phase adaptive treatment research design. Brief treatment (Phase 1) included 2-week buprenorphine-naloxone stabilization, 2-week taper, and 8-week post-medication follow-up. Patients with successful opioid use outcomes exited the study; unsuccessful patients entered Phase 2: extended (12-week) buprenorphine-naloxone treatment, 4-week taper, and 8-week post-medication follow-up. Main outcome measures Pre-defined “successful outcome” in each phase: composite measures indicating minimal or no opioid use, based on urine-confirmed self-reports. Interventions In both phases, patients were randomized to Standard Medical Management (SMM) or SMM+Opioid Drug Counseling (ODC); all received buprenorphine-naloxone. Results During Phase 1, only 6.6% (43/653) of patients had successful outcomes, with no difference between the SMM and SMM+ODC. In contrast, 49.2% (177/360) attained successful outcomes in Phase 2 during extended buprenorphine-naloxone treatment (week 12), with no difference between counseling conditions. Success rates 8 weeks after completing the buprenorphine-naloxone taper (Phase 2, week 24) dropped sharply to 8.6% (31/360), again with no counseling difference. In secondary analyses, successful Phase 2 outcomes were far more common while taking buprenorphine-naloxone than 8 weeks post-taper (49.2% (177/360) vs. 8.6% (31/360), p<0.001). Chronic pain did not affect opioid use outcomes; a history of ever using heroin was associated with lower Phase 2 success rates while taking buprenorphine-naloxone. Conclusions Prescription opioid-dependent patients are most likely to reduce opioid use during buprenorphine-naloxone treatment; if tapered off buprenorphine-naloxone, even after 12 weeks of treatment, the likelihood of unsuccessful outcome is extremely high, even among patients receiving counseling in addition to medical management. Trial Registration ClinicalTrials.gov number NCT00316277

Buprenorphine/Naloxone and Methadone Maintenance Treatment Outcomes for Opioid Analgesic, Heroin, and Combined Users: Findings From Starting Treatment With Agonist Replacement Therapies (START)

“…This fi nding supports previous reports indicating that heroin users are less likely to have successful treatment outcomes compared with OA users (Banta-Green et al, 2009;Brands et al, 2004;Moore et al, 2007). For example, one study found that any heroin use increased risk of poor treatment response compared with no heroin use in a sample that was primarily dependent on OAs (Weiss et al, 2011). As expected (Neufeld et al, 2008), injection status predicts poor treatment response to methadone and BUP treatment.…”

“…Similarly, injectors are less likely to complete treatment compared with non-injectors. These are particularly important fi ndings as retention in treatment is the best predictor of clinical outcomes (Corsi et al, 2009;Hutchinson et al, 2000;Weiss et al, 2011). Finally, as with opioid use at end of treatment, these results were irrespective of treatment assignment.…”

Antagonists in the medical management of opioid use disorders: Historical and existing treatment strategies

“…Although several studies showed that gradual outpatient buprenorphine tapers result in low rates of opioid abstinence (7–22% at 1 month),39, 40, 41 buprenorphine as maintenance therapy or for use in transition to other medications resulted in greater success. Patients treated with buprenorphine for the discontinuation of methadone or heroin exhibited milder withdrawal symptoms; therefore, buprenorphine gained acceptance as a medication that enabled easier transition onto naltrexone 23, 42, 43, 44, 45…”

Opioid-Abusing Health Care Professionals: Options for Treatment and Returning to Work After Treatment

“…3 Buprenorphine maintenance treatment of prescription opioid dependence is increasing in frequency and appears to be effective. 4 However, no data exist for buprenorphine maintenance treatment of addiction to fentanyl or sufentanil, the most common drugs of abuse among anesthesia personnel. 5 In addition, the role of buprenorphine maintenance treatment for such safety-sensitive specialties and professions has not been studied.…”