Evidence map›Paper›PMID 22065255›Full record

Trial reportArchives of general psychiatry2011

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 N Gourevitch, Deborah L Haller and 11 more

4 registry-linked trialsOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Archives of general psychiatry, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 301 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
301citing papers in PubMed, 10 pooled it
33.3field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00316277 phase3completednot on this map

A Two-Phase Randomized Controlled Clinical Trial of Buprenorphine/Naloxone Treatment Plus Standard Medical Management or Enhanced Medical Management for Opioid Analgesic Dependence

TypeinterventionalSponsorMclean HospitalRan2006 to 2013Enrolled653ConditionsOpiate Dependence, Substance-related Disorders, Opioid-related DisordersArmsStandard Medical Management (SMM) of Prescription Opiate Abuse, Enhanced Medical Management (EMM) of Prescription Opiate Abuse
NCT04257214 naactive not recruitingnot on this mapstarted 2020, after this paper: background citation

Identifying Optimal Psychosocial Interventions for Patients Receiving Office-Based Buprenorphine

TypeinterventionalSponsorPhiladelphia College of Osteopathic MedicineRan2020 to 2026Enrolled340ConditionsOpioid Use DisorderArmsPsychosocial treatment
NCT04650386 nacompletednot on this mapstarted 2020, after this paper: background citation

Enhancing Office-based Buprenorphine Treatment: An Adaptive Psychosocial Approach

TypeinterventionalSponsorPublic Health Management CorporationRan2020 to 2024Enrolled125ConditionsOpioid-use DisorderArmsPsychosocial support determined by adaptive treatment algorithm
NCT06359340 naactive not recruitingnot on this mapstarted 2020, after this paper: background citation

Identifying Optimal Psychosocial Interventions for Patients Receiving Office-Based Buprenorphine

TypeinterventionalSponsorPublic Health Management CorporationRan2020 to 2026Enrolled440ConditionsOpioid-use DisorderArmsPsychosocial treatment
3 · Its place in the literature

Who cites it

301 citing papers in PubMed, 10 syntheses or guidelines pooled it, 538 citations in OpenAlex.

  1. Pooled it
  2. CDC Clinical Practice Guideline for Prescribing Opioids for Pain - United States, 2022.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2022
    Guideline
  3. Pooled it
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  6. Contingency management for treatment attendance: A meta-analysis.Journal of substance abuse treatment · 2022
    Pooled it
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  10. Management of opioid use disorders: a national clinical practice guideline.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2018
    Guideline
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241 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors at 1 institution in 1 country.

Roger D WeissDivision of Alcohol and Drug Abuse, McLean Hospital, Belmont, MA 02478, USA. rweiss@mclean.harvard.edu
Jennifer Sharpe Potter
David A Fiellin
Marilyn Byrne
Hilary S Connery
William Dickinson
John Gardin
Margaret L Griffin
Marc N 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
Walter Ling
McLean Hospital · US

Funding

The National Drug Abuse Treatment Clinical Trials NetworkU10DA013045 · NIDA · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI LING, WALTER NMN · 1999 to 2015
$52.6M
CU PARTNERS: NY/LONG ISLAND REGIONAL NODEU10DA013035 · NIDA · NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC · PI NUNES, EDWARD V., ROTROSEN, JOHN P · 2001 to 2015
$47.6M
Clinical Trials Network, Ohio Valley Node U10DA013732U10DA013732 · NIDA · UNIVERSITY OF CINCINNATI · PI WINHUSEN, T JOHN · 2000 to 2015
$45.0M
Southern Consortium Node of the Clinical Trials NetworkU10DA013727 · NIDA · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI BRADY, KATHLEEN T. · 2000 to 2015
$34.4M
The National Drug Abuse Treatment Clinical Trials Network (U10)U10DA015831 · NIDA · MC LEAN HOSPITAL (BELMONT, MA) · PI CARROLL, KATHLEEN M., WEISS, ROGER D. · 2002 to 2015
$28.8M
CLINICAL TRIALS NETWORK: PACIFIC NORTHWEST NODEU10DA013714 · NIDA · UNIVERSITY OF WASHINGTON · PI DONOVAN, DENNIS MICHAEL, ROLL, JOHN M. · 2001 to 2015
$25.5M
Western States Node of the National Drug Abuse Treatment Clinical Trials NetworkU10DA015815 · NIDA · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI MCCARTY, DENNIS, SORENSEN, JAMES L · 2002 to 2015
$25.2M
Western States Node of the National Drug Abuse Treatment Clinical Trials Network (TMS for CUD) UG1DA015815 · NIDA · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Keith N. Humphreys, Philip Todd Korthuis · 2015 to 2026
$24.6M
CLINICAL TRIAL RESEARCH PROJECT COREU10DA020036 · NIDA · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI DALEY, DENNIS C · 2005 to 2015
$14.1M
Mentoring in Drug Abuse and Dual Diagnosis ResearchK24DA022288 · NIDA · MCLEAN HOSPITAL · PI WEISS, ROGER D. · 2007 to 2016
$1.8M
Role of Buprenorphine in Improving Clinical Care in Opioid Addiction and HIVK24DA023359 · NIDA · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI MCCANCE-KATZ, ELINORE F. · 2007 to 2011
$918k
Treatment of Opioid Dependence and Chronic PainK23DA022297 · NIDA · UNIVERSITY OF TEXAS HLTH SCIENCE CENTER · PI POTTER, JENNIFER SHARPE · 2008 to 2012
$878k
NHLBI NIH HHS HHSN2712005220HCNIDA NIH HHS 2U10DA013035NIDA NIH HHS 2U10DA013045NIDA NIH HHS 2U10DA013714NIDA NIH HHS 2U10DA013727NIDA NIH HHS 2U10DA015815NIDA NIH HHS 2U10DA015831NIDA NIH HHS 2U10DA020036NIDA NIH HHS 5U10DA013732NIDA NIH HHS HHSN271200522071CNIDA NIH HHS K23 DA022297NIDA NIH HHS K24 DA022288NIDA NIH HHS K24 DA023359NIDA NIH HHS U10 DA013035NIDA NIH HHS U10 DA013045NIDA NIH HHS U10 DA013714NIDA NIH HHS U10 DA013727NIDA NIH HHS U10 DA013732NIDA NIH HHS U10 DA015815NIDA NIH HHS U10 DA015831NIDA NIH HHS U10 DA020036NIDA NIH HHS UG1 DA015815PHS HHS HHSN271200522081C
6 · The paper itself

Abstract

contextNo randomized trials have examined treatments for prescription opioid dependence, despite its increasing prevalence.

objectiveTo evaluate the efficacy of brief and extended buprenorphine hydrochloride-naloxone hydrochloride treatment, with different counseling intensities, for patients dependent on prescription opioids.

designMultisite, 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.

settingTen US sites. Patients A total of 653 treatment-seeking outpatients dependent on prescription opioids.

interventionsIn both phases, patients were randomized to standard medical management (SMM) or SMM plus opioid dependence counseling; all received buprenorphine-naloxone.

main outcome measuresPredefined "successful outcome" in each phase: composite measures indicating minimal or no opioid use based on urine test-confirmed self-reports.

resultsDuring 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.

conclusionsPrescription 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.

Indexed as

CounselingAdultBuprenorphineCombined Modality TherapyDrug Therapy, CombinationFemaleHumansInterview, PsychologicalMaleNaloxoneNarcotic AntagonistsOpiate Substitution TreatmentOpioid-Related DisordersPsychiatric Status Rating ScalesTreatment OutcomeBuprenorphineNaloxoneNarcotic Antagonists

Identifiers

PMID22065255
PMCPMC3470422
OpenAlexW2127673034

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.