Evidence map›Paper›PMID 31013390›Full record

Trial reportAddiction (Abingdon, England)2019

Long-term safety of a weekly and monthly subcutaneous buprenorphine depot (CAM2038) in the treatment of adult out-patients with opioid use disorder.

Michael Frost, Genie L Bailey, Nicholas Lintzeris, John Strang, Adrian Dunlop, Edward V Nunes, Jakob Billeskov Jansen, Lars Chemnitz Frey, Bernd Weber, Paul Haber and 3 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Addiction (Abingdon, England), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02672111 (An Open-Label Multicenter Study Assessing the Long-Term Safety of a Once-Weekly and Once-Monthly, Long-Acting Subcutaneous Injection Depot of Buprenorphine), which is not on this map. Cited by 50 papers.

0numbers the graph read from it
0cells of the map it votes in
50citing papers in PubMed
11.3field-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.

NCT02672111 phase3completednot on this map

An Open-Label Multicenter Study Assessing the Long-Term Safety of a Once-Weekly and Once-Monthly, Long-Acting Subcutaneous Injection Depot of Buprenorphine (CAM2038) in Adult Outpatients With Opioid Use Disorder

TypeinterventionalSponsorBraeburn PharmaceuticalsRan2015 to 2017Enrolled228ConditionsOpioid Use DisorderArmsCAM2038 q1w or q4w exposure to SL BPN/NX, CAM2038 q1w or q4w new to BPN treatment
3 · Its place in the literature

Who cites it

50 citing papers in PubMed, 106 citations in OpenAlex.

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  11. The Socioeconomic Impact of Long-Acting Injectable Buprenorphine.ClinicoEconomics and outcomes research : CEOR · 2026
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  12. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 10 institutions in 6 countries.

Michael FrostThe Frost Medical Group, LLC, Conshohocken, PA, USA.
Genie L BaileyWarren Alpert Medical School of Brown University, Providence, RI, USA.
Nicholas LintzerisDiscipline of Addiction Medicine, University of Sydney, Surry Hills, NSW, Australia.
John StrangKing''s College London, National Addiction Centre, Institute of Psychiatry, Psychology and Neuroscience, London, UK.ORCID 0000-0002-5413-2725
Adrian DunlopHunter Medical Research Institute, University of Newcastle, Newcastle, NSW, Australia.
Edward V NunesColumbia University Medical Center, New York, NY, USA.ORCID 0000-0002-2055-3425
Jakob Billeskov JansenHøjbjerg, Denmark.
Lars Chemnitz FreyBehandlingscenter Odense, Odense C, Denmark.
Bernd WeberPraxiszentrum Friedrichsplatz, Competence Center for Addiction Medicine, Kassel, Germany.
Paul HaberDiscipline of Addiction Medicine, University of Sydney, Camperdown, NSW, Australia.
Sonia OosmanBraeburn Inc., Plymouth Meeting, PA, USA.
Sonnie KimBraeburn Inc., Plymouth Meeting, PA, USA.ORCID 0000-0003-0378-9759
Fredrik TibergCamurus AB, Lund, Sweden.
ECRI Institute · USThe University of Sydney · AUBrown University · USColumbia University Irving Medical Center · USHunter Medical Research Institute · AUIdeon Science Park · SEKing's College London · GBOdense Municipality · DKPraxis · EERex Medical (United States) · US

Funding

Braeburn Inc
6 · The paper itself

Abstract

aimsTo assess the long-term safety of subcutaneous buprenorphine (CAM2038) weekly and monthly depots.

designPhase 3, open-label, observational, multi-centre 48-week trial (ClinicalTrials.gov NCT02672111).

settingTwenty-six out-patient sites (United States, United Kingdom, Hungary, Denmark, Sweden, Germany, Australia) between 14 December 2015 and 12 April 2017.

participantsTwo hundred and twenty-eight adults with opioid use disorder; 227 received CAM2038 (37 initiated onto CAM2038 and 190 converted from sublingual buprenorphine).

interventionsCAM2038 weekly (8, 16, 24 or 32 mg) or monthly (64, 96, 128 or 160 mg) with flexible dosing and individualized titration utilizing multiple CAM2038 weekly and monthly doses. MEASUREMENTS: Safety variables, urine toxicology samples and self-reported illicit opioid use were collected at each visit. Participants were administered a patient satisfaction survey at months 6 and 12, completed by 162 of 227 (71.4%) participants.

findingsThe study treatment period was completed by 167 of 227 (73.6%) participants. At least one treatment-emergent adverse event (TEAE) was reported by 143 of 227 (63.0%) participants, of whom 60 of 227 (26.4%) reported as being drug-related. Most of the TEAEs, reported by 128 of 227 (56.4%) of participants, were mild or moderate in intensity. Injection-site reactions were reported by 46 of 227 (20.3%) participants, with most [45 of 46 (97.8%)] reported as mild to moderate. Five participants (2.2%) discontinued the study drug due to a TEAE, two cases (0.9%) of which were injection-site-related. No serious adverse events were attributed to the study drug. Among those remaining in the study, the percentage of opioid-negative urine tests combined with self-reports was 63.0% (17 of 27) in new-to-treatment participants and 82.8% (111 of 134) for those converted from sublingual buprenorphine. Participants reported high levels of satisfaction with CAM2038.

conclusionsSubcutaneous buprenorphine delivered weekly or monthly (CAM2038) was well tolerated, with a systemic safety profile consistent with the known profile of sublingual buprenorphine. CAM2038 weekly and monthly was associated with high retention rates and low levels of illicit opioid use throughout this study.

Indexed as

AdultAgedAnalgesics, OpioidAustraliaBuprenorphineDelayed-Action PreparationsDenmarkDrug MonitoringFemaleGermanyHumansHungaryInjections, SubcutaneousMaleMiddle AgedNarcotic AntagonistsAnalgesics, OpioidBuprenorphineDelayed-Action PreparationsNarcotic AntagonistsBuprenorphineCAM2038depotlong-term safetyopioid use disorderPhase 3 trial

Identifiers

PMID31013390
PMCPMC6771955
OpenAlexW2942243081

What OpenQuestion holds

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LicenceCC BY-NC
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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.