Evidence map›Paper›PMID 29627621›Full record

ArticleContemporary clinical trials2018

The OPTIMA study, buprenorphine/naloxone and methadone models of care for the treatment of prescription opioid use disorder: Study design and rationale.

M Eugenia Socias, Keith Ahamad, Bernard Le Foll, Ron Lim, Julie Bruneau, Benedikt Fischer, T Cameron Wild, Evan Wood, Didier Jutras-Aswad

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03033732 (Optimizing Patient Centered-Care), which is not on this map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
0.2field-weighted citation impact, top 38% 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.

NCT03033732 phase4completednot on this map

Optimizing Patient Centered-Care: A Pragmatic Randomized Control Trial Comparing Models of Care in the Management of Prescription Opioid Misuse (OPTIMA Trial)

TypeinterventionalSponsorDidier Jutras AswadRan2017 to 2020Enrolled272ConditionsOpioid Use DisorderArmsMethadone, Buprenorphine-Naloxone
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 34 citations in OpenAlex.

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  8. Sensitivity to change of generic preference-based instruments (EQ-5D-3L, EQ-5D-5L, and HUI3) in the context of treatment for people with prescription-type opioid use disorder in Canada.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2023
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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

9 authors at 9 institutions in 1 country.

M Eugenia SociasBritish Columbia Centre on Substance Use, St. Paul's Hospital, 608-1081 Burrard Street, Vancouver, BC V6Z 1Y6, Canada; Department of Medicine, Faculty of Medicine, University of British Columbia, 608-1081 Burrard Street, Vancouver, BC V6Z 1Y6, Canada. Electronic address: esocias@cfenet.ubc.ca.
Keith AhamadBritish Columbia Centre on Substance Use, St. Paul's Hospital, 608-1081 Burrard Street, Vancouver, BC V6Z 1Y6, Canada; Department of Family Practice, Faculty of Medicine, University of British Columbia, 3rd Floor David Strangway Building, 5950 University Boulevard, Vancouver, BC V6T 1Z3, Canada.
Bernard Le FollCentre for Addiction and Mental Health, 33 Russell Street, Toronto, ON M5S 2S1, Canada; Department of Family and Community Practice, University of Toronto, 500 University Avenue, 5th floor, Toronto, ON M5G 1V7, Canada; Department of Psychiatry, University of Toronto, 250 College Street, 8th floor, Toronto, ON M5T 1R8, Canada.
Ron LimDepartment of Medicine, Cumming School of Medicine, University of Calgary, 2500 University Drive NW, Calgary, AB T2N 1N4, Canada.
Julie BruneauResearch Center, Centre hospitalier de l'Université de Montréal (CRCHUM), 900 Saint Denis Street, Montréal, QC H2X 0A9, Canada; Department of Family Medicine, Faculty of Medicine, Université de Montréal, C.P. 6128, Succursale Centre-ville, Montréal, QC H3C 3J7, Canada.
Benedikt FischerCentre for Addiction and Mental Health, 33 Russell Street, Toronto, ON M5S 2S1, Canada; Department of Psychiatry, University of Toronto, 250 College Street, 8th floor, Toronto, ON M5T 1R8, Canada; Centre for Applied Research in Mental Health and Addiction, Faculty of Health Sciences, Simon Fraser University, Suite 2400, 515 W. Hastings Street, Vancouver, BC V6B 5K3, Canada.
T Cameron WildSchool of Public Health, University of Alberta, 3-300 Edmonton Clinic Health Academy 11405-87 Av, Edmonton, AL T6G 1C9, Canada.
Evan WoodBritish Columbia Centre on Substance Use, St. Paul's Hospital, 608-1081 Burrard Street, Vancouver, BC V6Z 1Y6, Canada; Department of Medicine, Faculty of Medicine, University of British Columbia, 608-1081 Burrard Street, Vancouver, BC V6Z 1Y6, Canada.
Didier Jutras-AswadDepartment of Medicine, Cumming School of Medicine, University of Calgary, 2500 University Drive NW, Calgary, AB T2N 1N4, Canada; Department of Psychiatry, Faculty of Medicine, Université de Montréal, C.P. 6128, Succursale Centre-ville, Montréal, QC H3C 3J7, Canada.
British Columbia Centre on Substance Use · CACentre Hospitalier de l’Université de Montréal · CASimon Fraser University · CASt. Paul's Hospital · CAUniversité de Montréal · CAUniversity of Alberta · CAUniversity of British Columbia · CAUniversity of Calgary · CAUniversity of Toronto · CA

Funding

Mentoring the next generation of addiction clinician scientists while responding to the opioid epidemicR25DA037756 · NIDA · UNIVERSITY OF BRITISH COLUMBIA · PI FAIRBAIRN, NADIA · 2014 to 2023
$3.6M
CIHR CIS-144301CIHR CIS-144302CIHR CIS-144303CIHR CIS-144304CIHR SMN-139148CIHR SMN-139149CIHR SMN-139150CIHR SMN-139151NIDA NIH HHS R25 DA037756
6 · The paper itself

Abstract

backgroundRates of non-medical use of opioids, and opioid use disorders (OUD) have been rising throughout North America. Methadone and buprenorphine/naloxone are the recommended first-line treatment options for OUD in Canada. Most studies to date have been conducted among heroin users, in controlled settings, and using similar strict dosing schedules (i.e., daily witnessed ingestion) despite buprenorphine/naloxone's superior safety profile, which allows a more flexible take-home dosing schedule. This study was designed to assess the relative effectiveness of buprenorphine/naloxone- and methadone-based models of opioid agonist therapy (OAT) for the treatment of prescription opioid use disorder (POUD) in routine clinical care.

methodsOPTIMA is a multicenter, open-label, pragmatic, randomized, two-arm, non-inferiority, 24-week study comparing the relative effectiveness of buprenorphine/naloxone (provided via flexible take-home doses) to methadone (provided via daily witnessed ingestion) models of OAT for the treatment of POUD. Approximately 276 non-pregnant adults meeting DSM-5 criteria for OUD, currently not in OAT, will be randomized across 7 Canadian sites. The primary outcome is reduction of non-medical opioid use, measured by bi-weekly urine drug screens during the 24-week study period. Secondary outcomes include treatment retention and satisfaction, safety, medication adherence, and patient engagement. DISCUSSION: The OPTIMA study is the first randomized clinical trial to compare the relative effectiveness of buprenorphine/naloxone (flexible take-home doses) versus methadone (daily witnessed ingestion) models of OAT for POUD in real-world clinical settings. This study will generate urgently needed evidence towards treatment options to guide the health system response to the ongoing opioid crisis. CLINICAL

trial registrationNCT03033732.

Indexed as

Buprenorphine, Naloxone Drug CombinationMethadoneOpioid-Related DisordersPrescription Drug OveruseAdultAnalgesics, OpioidBehavior Observation TechniquesCanadaDrug Administration ScheduleEquivalence Trials as TopicFemaleHumansMaleMulticenter Studies as TopicNarcotic AntagonistsNeeds AssessmentAnalgesics, OpioidBuprenorphine, Naloxone Drug CombinationMethadoneNarcotic AntagonistsBuprenorphine/naloxoneCanadaFentanylMethadoneOpioid agonist therapyOpioid use disorderPrescription opioids

Identifiers

PMID29627621
PMCPMC6625801
OpenAlexW2795456703

What OpenQuestion holds

Textmetadata
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.