No randomized trials have examined treatments for prescription opioid dependence,
despite its increasing prevalence.
To evaluate the efficacy of brief and extended buprenorphine hydrochloride-naloxone
hydrochloride treatment, with different counseling intensities, for patients dependent
on prescription opioids.
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 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 postmedication follow-up.
Ten US sites. Patients A total of 653 treatment-seeking outpatients dependent on prescription
opioids.
In both phases, patients were randomized to standard medical management (SMM) or SMM
plus opioid dependence counseling; all received buprenorphine-naloxone.
Predefined "successful outcome" in each phase: composite measures indicating minimal
or no opioid use based on urine test-confirmed self-reports.
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 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
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 < .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.
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 an unsuccessful outcome is high, even in
patients receiving counseling in addition to SMM.