Evidence map›Paper›PMID 24304412›Full record

Trial reportAddiction (Abingdon, England)2014

Maintenance treatment for opioid dependence with slow-release oral morphine: a randomized cross-over, non-inferiority study versus methadone.

Thilo Beck, Christian Haasen, Uwe Verthein, Stephan Walcher, Christoph Schuler, Markus Backmund, Christian Ruckes, Jens Reimer

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Addiction (Abingdon, England), 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01079117 (Randomised, Controlled Clinical Study Regarding the Feasibility of Converting Opiate Dependents From Methadone Substitutes to Slow Release Morphine Sulphate), which is not on this map. Cited by 34 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 3 pooled it
3.3field-weighted citation impact, top 8% 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.

NCT01079117 phase3completednot on this map

Randomised, Controlled Clinical Study Regarding the Feasibility of Converting Opiate Dependents From Methadone Substitutes to Slow Release Morphine Sulphate (Sevre-Long™)

TypeinterventionalSponsorMundipharma Medical CompanyRan2006 to 2011Enrolled276ConditionsOpiate DependentArmsSevre-Long™, Slow release oral morphine, Methadone
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 3 syntheses or guidelines pooled it, 98 citations in OpenAlex.

  1. Pooled it
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  3. Management of opioid use disorders: a national clinical practice guideline.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2018
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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

8 authors at 6 institutions in 3 countries.

Thilo BeckArud Centres for Addiction Medicine, Zurich, Switzerland.
Christian Haasen
Uwe Verthein
Stephan Walcher
Christoph Schuler
Markus Backmund
Christian Ruckes
Jens Reimer
Orthopädische Praxis · DEUniversität Hamburg · DEAddiction Switzerland · CHJohannes Gutenberg University Mainz · DEPraxis für Hämatologie und Onkologie · DEUniversity Medical Center Hamburg-Eppendorf · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo compare the efficacy of slow-release oral morphine (SROM) and methadone as maintenance medication for opioid dependence in patients previously treated with methadone.

designProspective, multiple-dose, open label, randomized, non-inferiority, cross-over study over two 11-week periods. Methadone treatment was switched to SROM with flexible dosing and vice versa according to period and sequence of treatment.

settingFourteen out-patient addiction treatment centres in Switzerland and Germany.

participantsAdults with opioid dependence in methadone maintenance programmes (dose ≥50 mg/day) for ≥26 weeks. MEASUREMENTS: The efficacy end-point was the proportion of heroin-positive urine samples per patient and period of treatment. Each week, two urine samples were collected, randomly selected and analysed for 6-monoacetyl-morphine and 6-acetylcodeine. Non-inferiority was concluded if the two-sided 95% confidence interval (CI) in the difference of proportions of positive urine samples was below the predefined boundary of 10%.

findingsOne hundred and fifty-seven patients fulfilled criteria to form the per protocol population. The proportion of heroin-positive urine samples under SROM treatment (0.20) was non-inferior to the proportion under methadone treatment (0.15) (least-squares mean difference 0.05; 95% CI = 0.02, 0.08; P > 0.01). The 95% CI fell within the 10% non-inferiority margin, confirming the non-inferiority of SROM to methadone. A dose-dependent effect was shown for SROM (i.e. decreasing proportions of heroin-positive urine samples with increasing SROM doses). Retention in treatment showed no significant differences between treatments (period 1/period 2: SROM: 88.7%/82.1%, methadone: 91.1%/88.0%; period 1: P = 0.50, period 2: P = 0.19). Overall, safety outcomes were similar between the two groups.

conclusionsSlow-release oral morphine appears to be at least as effective as methadone in treating people with opioid use disorder.

Indexed as

Administration, OralAdultCodeineCross-Over StudiesDelayed-Action PreparationsFemaleHumansMaintenance ChemotherapyMaleMedication AdherenceMethadoneMiddle AgedMorphineMorphine DerivativesNarcoticsOpiate Substitution Treatment6-O-monoacetylmorphineacetylcodeineCodeineDelayed-Action PreparationsMethadoneMorphineMorphine DerivativesNarcoticsDose-responsemaintenance treatmentmethadoneopioid addictionretention rateslow-release oral morphine

Identifiers

PMID24304412
PMCPMC4226326
OpenAlexW1585445625

What OpenQuestion holds

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LicenceCC BY-NC
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.