Evidence map›Paper›PMID 23919595›Full record

Trial reportAddiction (Abingdon, England)2013

Buprenorphine implants for treatment of opioid dependence: randomized comparison to placebo and sublingual buprenorphine/naloxone.

Richard N Rosenthal, Walter Ling, Paul Casadonte, Frank Vocci, Genie L Bailey, Kyle Kampman, Ashwin Patkar, Steven Chavoustie, Christine Blasey, Stacey Sigmon and 1 more

Registry-linked trialOpen access · greenAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Addiction (Abingdon, England), 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05594121 (A Pragmatic, Multi-centre, Open-label, Randomized, 12-month, Parallel Group, Superiority Study to Compare the Effectiveness of Subcutaneous Buprenorphine Depot), which is not on this map. Cited by 37 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 8 pooled it
5.5field-weighted citation impact, top 5% 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.

NCT05594121 phase4unknown statusnot on this mapstarted 2022, after this paper: background citation

A Pragmatic, Multi-centre, Open-label, Randomized, 12-month, Parallel Group, Superiority Study to Compare the Effectiveness of Subcutaneous Buprenorphine Depot (Sublocade®) vs Daily Sublingual Buprenorphine With Naloxone (Suboxone®) for the Treatment of Opioid Use Disorder

TypeinterventionalSponsorRoyal Victoria Hospital, CanadaRan2022 to 2024Enrolled90ConditionsModerate to Severe Opioid Use DisorderArmsExtended Release Subcutaneous Buprenorphine, Immediate Release Sublingual Buprenorphine
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 8 syntheses or guidelines pooled it, 96 citations in OpenAlex.

  1. Guideline
  2. Pooled it
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  7. Buprenorphine for managing opioid withdrawal.The Cochrane database of systematic reviews · 2017
    Pooled it
  8. Pooled it
  9. Trial
  10. Trial
  11. Review
  12. Article
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  17. French-Canadian Translation and Cultural Adaptation of the Clinical Opiate Withdrawal Scale: The COWS-FC.Canadian journal of psychiatry. Revue canadienne de psychiatrie · 2022
    Article
  18. Article
  19. Review
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 11 institutions in 1 country.

Richard N RosenthalDepartment of Psychiatry, St. Luke's-Roosevelt Hospital Center, Columbia University College of Physicians and Surgeons, New York, NY, USA.
Walter Ling
Paul Casadonte
Frank Vocci
Genie L Bailey
Kyle Kampman
Ashwin Patkar
Steven Chavoustie
Christine Blasey
Stacey Sigmon
Katherine L Beebe
Brown University · USColumbia University · USDuke University · USFriends Research Institute · USNew York University · USPalo Alto University · USSegal Institute for Clinical Research · USTitan Pharmaceuticals (United States) · USUniversity of California, Los Angeles · USUniversity of Pennsylvania · USUniversity of Vermont · US

Funding

A Six-Month, RCT of Probuphine Safety and Efficacy in Opioid AddictionRC2DA028910 · NIDA · TITAN PHARMACEUTICALS, INC. · PI BEEBE DEVARNEY, KATHERINE · 2009 to 2010
$7.6M
NIDA NIH HHS RC2 DA028910
6 · The paper itself

Abstract

aimsTo evaluate the safety and efficacy of buprenorphine implants (BI) versus placebo implants (PI) for the treatment of opioid dependence. A secondary aim compared BI to open-label sublingual buprenorphine/naloxone tablets (BNX).

designRandomized, double-blind, placebo-controlled trial. Subjects received either four buprenorphine implants (80 mg/implant) (n = 114), four placebo implants (n = 54) or open-label BNX (12-16 mg/day) (n = 119).

settingTwenty addiction treatment centers.

participantsAdult out-patients (ages 18-65) with DSM-IV-TR opioid dependence. MEASUREMENTS: The primary efficacy end-point was the percentage of urine samples negative for opioids collected from weeks 1 to 24, examined as a cumulative distribution function (CDF).

findingsThe BI CDF was significantly different from placebo (P < 0.0001). Mean [95% confidence interval (CI)] proportions of urines negative for opioids were: BI = 31.2% (25.3, 37.1) and PI = 13.4% (8.3, 18.6). BI subjects had a higher study completion rate relative to placebo (64 versus 26%, P < 0.0001), lower clinician-rated (P < 0.0001) and patient-rated (P < 0.0001) withdrawal, lower patient-ratings of craving (P < 0.0001) and better subjects' (P = 0.031) and clinicians' (P = 0.022) global ratings of improvement. BI also resulted in significantly lower cocaine use (P = 0.0016). Minor implant-site reactions were comparable in the buprenorphine [27.2% (31 of 114)] and placebo groups [25.9% (14 of 54)]. BI were non-inferior to BNX on percentage of urines negative for opioids [mean (95% CI) = 33.5 (27.3, 39.6); 95% CI for the difference of proportions = (-10.7, 6.2)].

conclusionsCompared with placebo, buprenorphine implants result in significantly less frequent opioid use and are non-inferior to sublingual buprenorphine/naloxone tablets.

Indexed as

Administration, SublingualAdolescentAdultAgedBuprenorphineDouble-Blind MethodDrug ImplantsFemaleHumansMaleMiddle AgedNaloxoneNarcotic AntagonistsOpiate Substitution TreatmentOpioid-Related DisordersTabletsBuprenorphineDrug ImplantsNaloxoneNarcotic AntagonistsTabletsBuprenorphinedrug addictiondrug implantsmaintenance therapyopioid dependencetreatment adherence

Identifiers

PMID23919595
PMCPMC4669043
OpenAlexW1897292339

What OpenQuestion holds

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LicenceTDM
Read underepoch 390

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.