Adjunctive counseling during brief and extended buprenorphine-naloxone treatment for prescription opioid dependence

A 2-phase randomized controlled trial

Roger D. Weiss, Jennifer Sharpe Potter, David A. Fiellin, Marilyn Byrne, Hilary S. Connery, William Dickinson, John Gardin, Margaret L. Griffin, Marc Gourevitch, Deborah L. Haller, Albert L. Hasson, Zhen Huang, Petra Jacobs, Andrzej S. Kosinski, Robert Lindblad, Elinore F. McCance-Katz, Scott E. Provost, Jeffrey Selzer, Eugene C. Somoza, Susan C. Sonne & 1 others Walter Ling

Research output: Contribution to journalArticle

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 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 languageEnglish (US)
Pages (from-to)1238-1246
Number of pages9
JournalArchives of General Psychiatry
Volume68
Issue number12
DOIs
StatePublished - Dec 2011

Fingerprint

varespladib methyl
Opioid Analgesics
Prescriptions
Counseling
Randomized Controlled Trials
Therapeutics
Outcome Assessment (Health Care)
Naloxone Drug Combination Buprenorphine
Prescription
Randomized Controlled Trial
Buprenorphine
Heroin
Naloxone
Chronic Pain
Research Design
Outpatients
Urine

ASJC Scopus subject areas

  • Arts and Humanities (miscellaneous)
  • Psychiatry and Mental health

Cite this

Adjunctive counseling during brief and extended buprenorphine-naloxone treatment for prescription opioid dependence : A 2-phase randomized controlled trial. / Weiss, Roger D.; Potter, Jennifer Sharpe; Fiellin, David A.; Byrne, Marilyn; Connery, Hilary S.; Dickinson, William; Gardin, John; Griffin, Margaret L.; Gourevitch, Marc; Haller, Deborah L.; Hasson, Albert L.; Huang, Zhen; Jacobs, Petra; Kosinski, Andrzej S.; Lindblad, Robert; McCance-Katz, Elinore F.; Provost, Scott E.; Selzer, Jeffrey; Somoza, Eugene C.; Sonne, Susan C.; Ling, Walter.

In: Archives of General Psychiatry, Vol. 68, No. 12, 12.2011, p. 1238-1246.

Research output: Contribution to journalArticle

Weiss, RD, Potter, JS, Fiellin, DA, Byrne, M, Connery, HS, Dickinson, W, Gardin, J, Griffin, ML, Gourevitch, M, 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 2011, 'Adjunctive counseling during brief and extended buprenorphine-naloxone treatment for prescription opioid dependence: A 2-phase randomized controlled trial', Archives of General Psychiatry, vol. 68, no. 12, pp. 1238-1246. https://doi.org/10.1001/archgenpsychiatry.2011.121
Weiss, Roger D. ; Potter, Jennifer Sharpe ; Fiellin, David A. ; Byrne, Marilyn ; Connery, Hilary S. ; Dickinson, William ; Gardin, John ; Griffin, Margaret L. ; Gourevitch, Marc ; Haller, Deborah L. ; Hasson, Albert L. ; Huang, Zhen ; Jacobs, Petra ; Kosinski, Andrzej S. ; Lindblad, Robert ; McCance-Katz, Elinore F. ; Provost, Scott E. ; Selzer, Jeffrey ; Somoza, Eugene C. ; Sonne, Susan C. ; Ling, Walter. / Adjunctive counseling during brief and extended buprenorphine-naloxone treatment for prescription opioid dependence : A 2-phase randomized controlled trial. In: Archives of General Psychiatry. 2011 ; Vol. 68, No. 12. pp. 1238-1246.
@article{3141568027e84f29b288ffa21ece92b9,
title = "Adjunctive counseling during brief and extended buprenorphine-naloxone treatment for prescription opioid dependence: A 2-phase randomized controlled trial",
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 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.",
author = "Weiss, {Roger D.} and Potter, {Jennifer Sharpe} and Fiellin, {David A.} and Marilyn Byrne and Connery, {Hilary S.} and William Dickinson and John Gardin and Griffin, {Margaret L.} and Marc Gourevitch and Haller, {Deborah L.} and Hasson, {Albert L.} and Zhen Huang and Petra Jacobs and Kosinski, {Andrzej S.} and Robert Lindblad and McCance-Katz, {Elinore F.} and Provost, {Scott E.} and Jeffrey Selzer and Somoza, {Eugene C.} and Sonne, {Susan C.} and Walter Ling",
year = "2011",
month = "12",
doi = "10.1001/archgenpsychiatry.2011.121",
language = "English (US)",
volume = "68",
pages = "1238--1246",
journal = "JAMA Psychiatry",
issn = "2168-622X",
publisher = "American Medical Association",
number = "12",

}

TY - JOUR

T1 - Adjunctive counseling during brief and extended buprenorphine-naloxone treatment for prescription opioid dependence

T2 - A 2-phase randomized controlled trial

AU - Weiss, Roger D.

AU - Potter, Jennifer Sharpe

AU - Fiellin, David A.

AU - Byrne, Marilyn

AU - Connery, Hilary S.

AU - Dickinson, William

AU - Gardin, John

AU - Griffin, Margaret L.

AU - Gourevitch, Marc

AU - Haller, Deborah L.

AU - Hasson, Albert L.

AU - Huang, Zhen

AU - Jacobs, Petra

AU - Kosinski, Andrzej S.

AU - Lindblad, Robert

AU - McCance-Katz, Elinore F.

AU - Provost, Scott E.

AU - Selzer, Jeffrey

AU - Somoza, Eugene C.

AU - Sonne, Susan C.

AU - Ling, Walter

PY - 2011/12

Y1 - 2011/12

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=83055171491&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=83055171491&partnerID=8YFLogxK

U2 - 10.1001/archgenpsychiatry.2011.121

DO - 10.1001/archgenpsychiatry.2011.121

M3 - Article

VL - 68

SP - 1238

EP - 1246

JO - JAMA Psychiatry

JF - JAMA Psychiatry

SN - 2168-622X

IS - 12

ER -