title: Adjunctive counseling during brief and extended buprenorphine-naloxone treatment for prescription opioid dependence: a 2-phase randomized controlled trial.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  Ten US sites. Patients A total of 653 treatment-seeking outpatients dependent on prescription opioids.
  
  
  METHODS
  In both phases, patients were randomized to standard medical management (SMM) or SMM plus opioid dependence counseling; all received buprenorphine-naloxone.
  
  
  METHODS
  Predefined "successful outcome" in each phase: composite measures indicating minimal or no opioid use based on urine test-confirmed self-reports.
  
  
  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 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.
  
  
  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 an unsuccessful outcome is high, even in patients receiving counseling in addition to SMM.
authors: Division of Alcohol and Drug Abuse, McLean Hospital, Belmont, MA 02478, USA. rweiss@mclean.harvard.edu
authors: Roger D
authors: RD
authors: Weiss
authors: Jennifer Sharpe
authors: JS
authors: Potter
authors: David A
authors: DA
authors: Fiellin
authors: Marilyn
authors: M
authors: Byrne
authors: Hilary S
authors: HS
authors: Connery
authors: William
authors: W
authors: Dickinson
authors: John
authors: J
authors: Gardin
authors: Margaret L
authors: ML
authors: Griffin
authors: Marc N
authors: MN
authors: Gourevitch
authors: Deborah L
authors: DL
authors: Haller
authors: Albert L
authors: AL
authors: Hasson
authors: Zhen
authors: Z
authors: Huang
authors: Petra
authors: P
authors: Jacobs
authors: Andrzej S
authors: AS
authors: Kosinski
authors: Robert
authors: R
authors: Lindblad
authors: Elinore F
authors: EF
authors: McCance-Katz
authors: Scott E
authors: SE
authors: Provost
authors: Jeffrey
authors: J
authors: Selzer
authors: Eugene C
authors: EC
authors: Somoza
authors: Susan C
authors: SC
authors: Sonne
authors: Walter
authors: W
authors: Ling
mesh_terms: D000328:Adult; D002047:Buprenorphine / Q000008:administration & dosage / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D003376:Counseling; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007406:Interview, Psychological; D008297:Male; D009270:Naloxone / Q000008:administration & dosage / Q000627:therapeutic use*; D009292:Narcotic Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D058850:Opiate Substitution Treatment / Q000379:methods*; D009293:Opioid-Related Disorders / Q000188:drug therapy / Q000628:therapy*; D011569:Psychiatric Status Rating Scales; D016896:Treatment Outcome
chemical_list: D009292:Narcotic Antagonists; D009270:Naloxone; D002047:Buprenorphine