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Adjunctive counseling during brief and extended buprenorphine-naloxone treatment for prescription opioid dependence: a 2-phase randomized controlled trial.

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 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. 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 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.

Pubmed ID: 22065255

Authors

  • Weiss RD
  • Potter JS
  • Fiellin DA
  • Byrne M
  • Connery HS
  • Dickinson W
  • Gardin J
  • Griffin ML
  • Gourevitch MN
  • Haller DL
  • Hasson AL
  • Huang Z
  • Jacobs P
  • Kosinski AS
  • Lindblad R
  • McCance-Katz EF
  • Provost SE
  • Selzer J
  • Somoza EC
  • Sonne SC
  • Ling W

Journal

Archives of general psychiatry

Publication Data

December 7, 2011

Associated Grants

  • Agency: NIDA NIH HHS, Id: 2U10DA013035
  • Agency: NIDA NIH HHS, Id: 2U10DA013045
  • Agency: NIDA NIH HHS, Id: 2U10DA013714
  • Agency: NIDA NIH HHS, Id: 2U10DA013727
  • Agency: NIDA NIH HHS, Id: 2U10DA015815
  • Agency: NIDA NIH HHS, Id: 2U10DA015831
  • Agency: NIDA NIH HHS, Id: 2U10DA020036
  • Agency: NIDA NIH HHS, Id: 5U10DA013732
  • Agency: PHS HHS, Id: HHSN271200522071C
  • Agency: PHS HHS, Id: HHSN271200522081C
  • Agency: NHLBI NIH HHS, Id: HHSN2712005220HC
  • Agency: NIDA NIH HHS, Id: K23 DA022297
  • Agency: NIDA NIH HHS, Id: K23 DA022297
  • Agency: NIDA NIH HHS, Id: K24 DA022288
  • Agency: NIDA NIH HHS, Id: K24 DA022288
  • Agency: NIDA NIH HHS, Id: K24 DA022288-05
  • Agency: NIDA NIH HHS, Id: K24 DA023359
  • Agency: NIDA NIH HHS, Id: K24 DA023359
  • Agency: NIDA NIH HHS, Id: U10 DA013035
  • Agency: NIDA NIH HHS, Id: U10 DA013045
  • Agency: NIDA NIH HHS, Id: U10 DA013714
  • Agency: NIDA NIH HHS, Id: U10 DA013727
  • Agency: NIDA NIH HHS, Id: U10 DA013732
  • Agency: NIDA NIH HHS, Id: U10 DA015815
  • Agency: NIDA NIH HHS, Id: U10 DA015831
  • Agency: NIDA NIH HHS, Id: U10 DA015831-10
  • Agency: NIDA NIH HHS, Id: U10 DA020036

Mesh Terms

  • Adult
  • Buprenorphine
  • Combined Modality Therapy
  • Counseling
  • Drug Therapy, Combination
  • Female
  • Humans
  • Interview, Psychological
  • Male
  • Naloxone
  • Narcotic Antagonists
  • Opiate Substitution Treatment
  • Opioid-Related Disorders
  • Psychiatric Status Rating Scales
  • Treatment Outcome