Evidence map›Paper›PMID 36270754›Full record

ArticleBMJ open2022

Experience and response to a randomised controlled trial of extended-release injectable buprenorphine versus sublingual tablet buprenorphine and oral liquid methadone for opioid use disorder: protocol for a mixed-methods evaluation.

Natalie Lowry, Fiona Cowden, Edward Day, Eilish Gilvarry, Stacey Johnstone, Robbie Murray, Mike Kelleher, Luke Mitcheson, John Marsden

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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

2 citing papers in PubMed.

  1. Trial
  2. Article
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

9 authors.

Natalie LowryAddictions Department, King's College London Institute of Psychiatry Psychology and Neuroscience, London, UK natalie.m.lowry@kcl.ac.uk.ORCID 0000-0002-9137-5005
Fiona CowdenDundee Drug & Alcohol Recovery Service, Constitution House, Scotland, UK.
Edward DayBirmingham and Solihull Mental Health NHS Foundation Trust, Birmingham, UK.
Eilish GilvarryCumbria, Northumberland, Tyne & Wear NHS Foundation Trust, Newcastle Treatment and Recovery (NTaR), Newcastle Upon Tyne, UK.
Stacey JohnstoneDundee Drug & Alcohol Recovery Service, Constitution House, Scotland, UK.
Robbie MurrayCumbria, Northumberland, Tyne & Wear NHS Foundation Trust, Newcastle Treatment and Recovery (NTaR), Newcastle Upon Tyne, UK.
Mike KelleherAddictions Department, King's College London Institute of Psychiatry Psychology and Neuroscience, London, UK.
Luke MitchesonAddictions Department, King's College London Institute of Psychiatry Psychology and Neuroscience, London, UK.
John MarsdenAddictions Department, King's College London Institute of Psychiatry Psychology and Neuroscience, London, UK.ORCID 0000-0002-1307-2498

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionOpioid use disorder (OUD) is a debilitating and persistent disorder. The standard-of-care treatment is daily maintenance dosing of sublingual buprenorphine (BUP-SL) or oral methadone (MET). Monthly, extended-release, subcutaneous injectable buprenorphine (BUP-XR) has been developed to enhance treatment effectiveness. This study aims to investigate the experiences of participants who have been offered BUP-XR (evaluation 1), health-related quality-of-life among participants who have opted to receive BUP-XR longer term (evaluation 2) and the experiences of participants allocated to receive BUP-XR or BUP-SL or MET with the offer of adjunctive personalised psychosocial intervention (evaluation 3). METHODS AND ANALYSIS: Three qualitative-quantitative (mixed-methods) evaluations embedded in a five-centre, head-to-head, randomised controlled trial of BUP-XR versus BUP-SL and MET in the UK. Evaluation 1 is a four-centre interview anchored on an OUD-related topic guide and conducted after the 24-week trial endpoint. Evaluation 2 is a two-centre interview anchored on medications for opioid use disorder-specific quality-of-life topic guide conducted among participants after 12-24 months. Evaluation 3: single-centre interview after the 24-week trial endpoint. All evaluations include selected trial clinical measures, with evaluation 2 incorporating additional questionnaires. Target participant recruitment for evaluations 1 and 2 is 15 participants per centre (n=60 and n=30, respectively). Recruitment for evaluation 3 is 15 participants per treatment arm (n=30). Each evaluation will be underpinned by theory, drawing on constructs from the behavioural model for health service use or the health-related quality-of-life model. Qualitative data analysis will be by iterative categorisation. ETHICS AND DISSEMINATION: Study protocol, consent materials and questionnaires were approved by the London-Brighton and Sussex research ethics committee (reference: 19/LO/0483) and the Health Research Authority (IRAS project number 255522). Participants will be provided with information sheets and informed written consent will be obtained for each evaluation. Study findings will be disseminated through peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER: 2018-004460-63.

Indexed as

BuprenorphineOpioid-Related DisordersHumansMethadoneNarcotic AntagonistsRandomized Controlled Trials as TopicTabletsBuprenorphineMethadoneNarcotic AntagonistsTabletsclinical trialsqualitative researchsubstance misuse

Identifiers

PMID36270754
PMCPMC9594511

What OpenQuestion holds

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LicenceCC BY-NC
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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.