Evidence map›Paper›PMID 30956839›Full record

ArticleJournal of addiction2019

Suboxone Treatment and Recovery Trial (STAR-T): Study Protocol for a Randomised Controlled Trial of Opioid Medication Assisted Treatment with Adjunctive Medication Management Using Therapeutic Drug Monitoring and Contingency Management.

Hesham Elarabi, Abuelgasim Elrasheed, Ahmed Ali, Mansour Shawky, Nael Hasan, Tarek A Gawad, Abdu Adem, John Marsden

Open access · hybridAbstract read
In one paragraph

Article in Journal of addiction, 2019. 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
2.0field-weighted citation impact, top 14% 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

2 citing papers in PubMed, 10 citations in OpenAlex.

  1. Review
  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

8 authors at 2 institutions in 2 countries.

Hesham ElarabiAddictions Department, Institute of Psychiatry, Psychology and Neurosciences, King's College London, 4-Windsor Walk, ASB, Denmark Hill, SE5 8BB, London, UK.ORCID 0000-0002-1849-3750
Abuelgasim ElrasheedNational Rehabilitation Centre, UAE, P.O. Box 55001, Abu Dhabi, Shakhboot City, UAE.
Ahmed AliNational Rehabilitation Centre, UAE, P.O. Box 55001, Abu Dhabi, Shakhboot City, UAE.
Mansour ShawkyNational Rehabilitation Centre, UAE, P.O. Box 55001, Abu Dhabi, Shakhboot City, UAE.
Nael HasanNational Rehabilitation Centre, UAE, P.O. Box 55001, Abu Dhabi, Shakhboot City, UAE.
Tarek A GawadNational Rehabilitation Centre, UAE, P.O. Box 55001, Abu Dhabi, Shakhboot City, UAE.
Abdu AdemCollege of Medicine and Health Sciences, United Arab Emirates University, P.O. Box 15551, Alain, AD, UAE.
John MarsdenAddictions Department, Institute of Psychiatry, Psychology and Neurosciences, King's College London, Addiction Sciences Building, 4 Windsor Walk, Demark Hill, London, Denmark Hill, SE5 8AF, UK.
King's College London · GBUnited Arab Emirates University · AE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionOpioid assisted treatment (OAT) with buprenorphine (BUP) is front-line medical maintenance intervention for illicit and prescription opioid use disorder (OUD). In many clinics, opioid medication is dispensed for several days for self-administration. This provides flexibility to the patient but may compromise the effectiveness of OAT because of nonadherence or medication diversion. OAT can be delivered as an entirely supervised intervention, but many patients discontinue treatment under this arrangement and dispensing costs may be prohibitive. An alternative is to enable patients to receive take-home doses contingent on OAT adherence guided by a medication management framework using Therapeutic Drug Monitoring (TDM) alongside negative urine drug screens (UDS) to provide evidence of abstinence. TDM is recommended to monitor adherence with BUP but it has not been applied in OAT programs and evaluation research to date.

methodsThe Suboxone Treatment and Recovery Trial (STAR-T) is a single site, 16-week, parallel-group, randomised controlled trial. The aim of the study is to determine the effectiveness of a medication management framework including TDM and UDS to enable patients enrolled on outpatient OAT (with buprenorphine/naloxone [sublingual film formulation; BUP/NX-F; Suboxone™]) to receive stepped take-home doses. Following stabilisation during inpatient care, adult participants with illicit or prescription OUD were allocated (1:1) to receive (1) BUP/NX-F plus medication management for take-home doses based on TDM, UDS, and contingency management protocol (the experimental group) or (2) BUP/NX-F plus UDS only (treatment-as-usual, the control group). The primary outcome is the mean percentage of negative UDS over 16 weeks. The secondary outcome is treatment retention defined as completion of 16 weeks of OAT without interruption. There will be an exploratory analysis of the association between participant characteristics, clinical data, and outcomes.

conclusionsProviding BUP/NX-F take-home doses contingent on adherence and opioid abstinence may enable OAT to be delivered flexibly and effectively.

trial registrationISRCTN41645723 is retrospectively registered on 15/11/2015.

Identifiers

PMID30956839
PMCPMC6425325
OpenAlexW2918999655

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.