Evidence map›Paper›PMID 23264315›Full record

ArticleJournal of opioid management

Sublingual buprenorphine/naloxone for chronic pain in at-risk patients: development and pilot test of a clinical protocol.

Andrew Rosenblum, Ricardo A Cruciani, Eric C Strain, Charles M Cleland, Herman Joseph, Stephen Magura, Lisa A Marsch, Laura F McNicholas, Seddon R Savage, Arun Sundaram and 1 more

Open access · greenAbstract read
In one paragraph

Article in Journal of opioid management. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 5 pooled it
6.6field-weighted citation impact, top 3% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 5 syntheses or guidelines pooled it, 50 citations in OpenAlex.

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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

11 authors at 6 institutions in 2 countries.

Andrew RosenblumInstitute for Treatment and Services Research, National Development and Research Institutes, New York, NY, USA.
Ricardo A Cruciani
Eric C Strain
Charles M Cleland
Herman Joseph
Stephen Magura
Lisa A Marsch
Laura F McNicholas
Seddon R Savage
Arun Sundaram
Russell K Portenoy
Yeshiva University · USDartmouth Hospital · GBNational Development and Research Institutes · USJohns Hopkins University · USNew York University · USWestern Michigan University · US

Funding

Mentoring of Clinical Investigators in Patient Oriented ResearchK24DA023186 · NIDA · JOHNS HOPKINS UNIVERSITY · PI STRAIN, ERIC C. · 2007 to 2016
$1.8M
Sublingual Buprenorphine for Chronic Pain in Patients at Risk for Drug AbuseR21DA022675 · NIDA · NATIONAL DEVELOPMENT AND RESEARCH INSTITUTES, INC. · PI ROSENBLUM, ANDREW BRUCE · 2006 to 2007
$443k
NIDA NIH HHS K24 DA023186NIDA NIH HHS R21 DA022675
6 · The paper itself

Abstract

objectiveSublingual buprenorphine/naloxone (Bup/Nx) is approved for addiction treatment and may be useful for pain management, particularly in opioid-treated patients with pain with nonadherence behaviors. The transition of opioid-treated patients with pain to buprenorphine carries the risk of precipitated withdrawal and increased pain. This study convened pain and addiction specialists to develop and pilot a clinical protocol for safe transitioning to Bup/Nx.

designThe protocol was revised three times based on outside expert review and pilot study observations. The pilot was conducted with a prospective cohort of 12 patients with moderate to severe chronic pain, who were receiving long-term opioid therapy with any full m-agonist drug, and had exhibited one or more aberrant drug-related behaviors. Patients were followed up for 3-6 months with the expectation that they would experience few adverse events (AEs) and report lower pain severity.

resultsThe three patients on the highest baseline opioid dose (equivalent to 303-450 mg of oral morphine) and the three on the lowest doses (≤20 mg) had early AEs when switched to Bup/Nx and did not complete the trial. Of the remaining six, one withdrew due to AEs; one responded well, then withdrew; and four completed a 3-month trial. A mixed-effects model controlling for dropouts found that average and worst pain significantly decreased after the switch to Bup/Nx (both p < 0.01).

conclusionBased on this experience, the protocol recommends Bup/Nx for pain only when baseline opioid doses are within bounds that reduce AEs at transition and incorporates dose flexibility to further reduce risks. This protocol warrants further testing.

Indexed as

Administration, SublingualAdultAgedAnalgesics, OpioidBuprenorphineBuprenorphine, Naloxone Drug CombinationChronic PainCohort StudiesDose-Response Relationship, DrugFemaleFollow-Up StudiesHumansLongitudinal StudiesMaleMiddle AgedModels, StatisticalAnalgesics, OpioidBuprenorphineBuprenorphine, Naloxone Drug CombinationNaloxoneNarcotic Antagonists

Identifiers

PMID23264315
PMCPMC3630795
OpenAlexW2035883503

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.