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 hydrochloride-naloxone hydrochloride treatment, with different counseling intensities, for patients dependent on prescription opioids. Design: Multisite, randomized clinical trial using a 2-phase adaptive treatment research design. Brief treatment (phase 1) included 2-week buprenorphine-naloxone stabilization, 2-week taper, and 8-week postmedication followup. 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 postmedication follow-up. Setting: Ten US sites. Patients: A total of 653 treatment-seeking outpatients dependent on prescription opioids. Interventions: In both phases, patients were randomized to standard medical management (SMM) or SMM plus opioid dependence counseling; all received buprenorphine- naloxone. Main Outcome Measures: Predefined "successful outcome"in each phase: composite measures indicating minimal or no opioid use based on urine test-confirmed selfreports. Results: During phase 1, only 6.6% (43 of 653) of patients had successful outcomes, with no difference between SMM and SMM plus opioid dependence counseling. In contrast, 49.2% (177 of 360) attained successful outcomes in phase 2 during extended buprenorphinenaloxone treatment (week 12), with no difference between counseling conditions. Success rates 8 weeks after completing the buprenorphine-naloxone taper (phase 2, week 24) dropped to 8.6% (31 of 360), again with no counseling difference. In secondary analyses, successful phase 2 outcomes were more common while taking buprenorphine-naloxone than 8 weeks after taper (49.2% [177 of 360] vs 8.6% [31 of 360], P≲λτ∀.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 buprenorphinenaloxone treatment; if tapered off buprenorphinenaloxone, even after 12 weeks of treatment, the likelihood of an unsuccessful outcome is high, even in patients receiving counseling in addition to SMM. Trial Registration: clinicaltrials.gov Identifier: NCT00316277.
|Original language||English (US)|
|Number of pages||9|
|Journal||Archives of General Psychiatry|
|State||Published - Dec 2011|
ASJC Scopus subject areas
- Arts and Humanities (miscellaneous)
- Psychiatry and Mental health