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Opioid Use DisorderPhase 4OPTIMANCT03033732

A Pragmatic Randomized Control Trial Comparing Models of Care in the Management of Prescription Opioid Misuse

A Phase 4 study testing Methadone and Buprenorphine-Naloxone in people with Opioid Use Disorder, run by Didier Jutras Aswad at 7 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This trial evaluates two standard of care treatments for opioid addiction: methadone and buprenorphine/naloxone. In order to improve patient care, the study will address real-world treatment conditions, including strict regulations for methadone dosing (i.e. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Opioid Use Disorder
What is being tested?
Methadone and Buprenorphine-Naloxone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
272 participants
Where
7 sitesCanada
Study dates
2 Oct 2017to 31 Dec 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Be aged between 18 and 64 years of age inclusively;
  • Prescription opioid use disorder (as defined by the Diagnostic and Statistical Manual of Mental Disorders-5 criteria), which requires opioid agonist therapy as per the discretion of the physician;
  • Female participants may be eligible if:
  • Is of non-childbearing potential, defined as (i) post-menopausal (12 months of spontaneous amenorrhea and ≥45 years of age); or (ii) documented surgically sterilized (i.e., tubal ligation, hysterectomy, or bilateral oophorectomy).
  • Is of childbearing potential, has a negative pregnancy test at screening and and agrees to use an acceptable method of birth control throughout study;
  • Be willing to be randomized to 24 weeks of either methadone or buprenorphine/naloxone adapted model of care, and to be followed for the duration of the trial;
Show all 9Show fewer
  • Be able to provide written informed consent;
  • Be willing to comply with study procedures;
  • Be able to communicate in English or French.

Who cannot join

  • Any disabling medical condition as assessed by medical history, physical exam, vital signs and/or laboratory assessments that, in the opinion of the study physician, precludes the safe participation in the study or the ability to provide fully informed consent;
  • Any disabling, unstable or acute mental condition that in the opinion of the study physician precludes safe participation in the study or ability to provide fully informed consent;
  • Heroin reported as the most frequently used opioid in the past 30 days;
  • Taken methadone or buprenorphine/naloxone for Opioid Use Disorder maintenance treatment in the four weeks prior to screening;
  • Pain of sufficient severity as to require ongoing pain management with opioids;
  • History of a severe adverse event, hypersensitivity reaction, or allergic reaction to either methadone or buprenorphine/naloxone;
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  • Pregnant, nursing, or planning to become pregnant during the study period;
  • Currently taking or have taken an investigational drug in another study in the last 30 days, confirmed via self-report;
  • Pending legal action or other reasons in the opinion of the study physician that might prevent completion of the study;
  • Presence of a substance use disorder that, in the opinion of the study physician, precludes safe participation in the study (e.g. unstable or severe alcohol use disorder, unstable or severe benzodiazepine use disorder);
  • Current treatment with medications that may interact with either methadone or buprenorphine/naloxone (e.g. Clonazepam, Benzodiazepines) OR anticipation that the patient may need to initiate such treatment during the trial that is deemed unsafe by the study physician or could prevent study completion;

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Canada7 sites

  • Calgary Opioid Dependency Program

    Calgary, Alberta, T2R 0X7

  • Edmonton Opioid Dependency Program

    Edmonton, Alberta, T5J 0G5

  • Ontario Addiction Treatment Centres- Sudbury Clinic

    Greater Sudbury, Ontario, P3C 5K8

  • Centre de Recherche du CHUM

    Montreal, Quebec, H2X 0A9

  • Centre de Recherche et d'Aide pour Narcomane

    Montreal, Quebec, H2X 1S7

  • Addiction Medicine Service- Centre for Addictions and Mental Health

    Toronto, Ontario, M6J 1H4

  • Rapid Access Addictions Clinic-St. Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

About this study

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

This trial evaluates two standard of care treatments for opioid addiction: methadone and buprenorphine/naloxone. In order to improve patient care, the study will address real-world treatment conditions, including strict regulations for methadone dosing (i.e. initially dispensed daily at the pharmacy until stabilisation) vs. flexible take-home dosing for buprenorphine/naloxone. The OPTIMA study is designed with the intention to support patient-provider decision-making and evaluate health related outcomes with the overall aim of improving treatment outcomes through enhancing patient-centered approaches in clinical care.

Read the detailed description

This is a multicenter, open-label, 2-arm, randomized trial with a pragmatic design involving 276 individuals with prescription opioid use disorder. Participants will be randomized to receive either:

  1. Methadone provided via initial daily witnessed ingestion as per local guidelines.
  2. Buprenorphine/naloxone maintenance therapy provided via flexible take-home dose regimens dispensed as per the physician's discretion, once clinical stability is achieved.

Once randomized to a study medication and treatment initiation and induction has begun, study physicians and participants will discuss the treatment plans and procedures going forward. Once treatment initiation has taken place, the participant will attend study visits every 2 weeks (including collection of urine samples) for the 24-week intervention period. For all study sites, standardized guidelines exist and will be adhered to for the safe induction of both medications. Frequency of illicit opioid use, intensity of craving and other secondary endpoints will also be assessed via standardized questionnaires.

Being tested
Methadone, Buprenorphine-Naloxone
Keywords
opioid agonist treatment, pragmatic, prescription opioid use, patient engagement
Medical subject headings
Opioid-Related Disorders, Patient Participation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MethadoneDrug

    Also called Methadose

    Methadone is a synthetic analgesic drug used as a substitute drug in the treatment of opioid use disorder. Methadone is administered via strict daily witnessed ingestion.

  • Buprenorphine-NaloxoneDrug

    Also called Suboxone

    Buprenorphine/Naloxone is an opioid agonist treatment used to treat opioid use disorder. Buprenorphine/Naloxone is administered via flexible take home dosing once the patient has reached stabilization as per physician discretion.

Study groups in NCT03033732
Study groupRoleWhat they receive
MethadoneOtherOpioid agonist treatment for opioid use disorder. Ingested in liquid oral form via strict initial daily witnessed ingestion as per local guidelines.
Receives: Drug: Methadone
Buprenorphine/NaloxoneOtherOpioid agonist treatment for opioid use disorder. Ingested orally via sublingual tablet form, flexible take home dosing.
Receives: Drug: Buprenorphine-Naloxone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Opioid Use

    Opioid use will be measured by the overall proportion of opioid-free urine drug screens (UDS) during the 24 weeks of the trial (excluding the assigned metabolites of opioid agonist treatments, as appropriate), with missing values defined as positive UDS (binary, laboratory assay).

    Measured: 24 weeks

Secondary outcomes (5)

  1. Retention in treatment

    Retention in treatment is defined as the proportion of participants on assigned opioid agonist treatment (OAT) at the end of the study, as defined by having both a) an active prescription for the assigned OAT at week 24, and b) a positive UDS result for the assigned OAT at week 24.

    Measured: 24 weeks

  2. Opioid Agonist Treatment (OAT) Medication Adherence

    OAT medication adherence is defined as the proportion of assigned treatment doses received over the 24-week trial period assessed by both Pharmacy Abstraction and participant self-report.

    Measured: 24 weeks

  3. Safety will be evaluated by monitoring adverse events (AEs) and serious adverse events (SAEs)

    Safety will be evaluated by monitoring adverse events (AEs) and serious adverse events (SAEs) throughout the duration of the trial. Adverse events and SAEs will be collected during study visits by means of open questions (e.g., has there been any changes to your health since the last study visit?). Also, the observation of clinically significant change in lab test results, fatal or non-fatal overdoses, and precipitated withdrawal symptoms from buprenorphine/naloxone inductions will be used to document AEs and SAEs. All AEs and SAEs will be documented using an AE Log in which the date and time of onset, the end date and time (i.e., when the AE was resolved or stabilized), the severity of the event, any action taken with respect to the study medication (e.g., no treatment or dose adjustment), and the relationship with study protocol or study medication will be recorded.

    Measured: 24 weeks

  4. Patient Satisfaction

    Patient satisfaction to the assigned treatment will be recorded on the Client Satisfaction Questionnaire (CSQ-8) and will be administered at 4, 12, and 24 weeks (end of study).

    Measured: 24 weeks

  5. Patient Engagement

    Patient engagement in treatment will be measured through self-report questionnaires administered at Treatment Initiation, week 4, week 12, and week 24 visits. The primary measure of ongoing patient engagement will be administered at Treatment Initiation and every 2 weeks.

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2017 (estimated)
  2. Study start2 Oct 2017
  3. Primary completion31 Mar 2020
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
272 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03033732
Sponsor's protocol ID
CRISM 001
Acronym
OPTIMA
Status last verified
Jun 2021
First submitted
10 Jan 2017
Last updated
16 Jun 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bastien G, Abboud A, McAnulty C, Mahroug A, Le Foll B, Socias ME, Juteau LC, Dubreucq S, Jutras-Aswad D. Concordance Between Urine Drug Screening and Self-Reported Use in the Context of a Pragmatic Randomized-Controlled Trial in People with Prescription-Type Opioid Use Disorder: Concordance entre le depistage de drogues dans l'urine et l'usage autodeclare dans le contexte d'un essai pragmatique controle a repartition aleatoire chez des personnes presentant un trouble lie a l'usage d'opioides vendus sur ordonnance. Can J Psychiatry. 2026 Jan;71(1):41-52. doi: 10.1177/07067437251367180. Epub 2025 Aug 28.

    PubMed 40874578

  • Bouthillier A, Bastien G, McAnulty C, Bakouni H, Le Foll B, Socias ME, Jutras-Aswad D. Opioid consumption frequency and its associations with potential life problems during opioid agonist treatment in individuals with prescription-type opioid use disorder: exploratory results from the OPTIMA Study. Harm Reduct J. 2025 Feb 8;22(1):14. doi: 10.1186/s12954-025-01157-4.

    PubMed 39923043

  • Langlois J, Fairbairn N, Jutras-Aswad D, Le Foll B, Lim R, Socias ME. Characterising methamphetamine/amphetamine use among opioid agonist therapy-seeking adults with prescription-type opioid use disorder in Canada. Drug Alcohol Rev. 2024 Nov;43(7):1905-1912. doi: 10.1111/dar.13863. Epub 2024 May 9.

    PubMed 38721650

  • Bastien G, Abboud A, McAnulty C, Elkrief L, Ledjiar O, Socias ME, Le Foll B, Bahji A, Brissette S, Marsan S, Jutras-Aswad D. Impact of Depressive Symptom Severity on Buprenorphine/Naloxone and Methadone Outcomes in People With Prescription-Type Opioid Use Disorder: Results From a Pragmatic Randomized Controlled Trial. J Dual Diagn. 2024 Jul-Sep;20(3):189-200. doi: 10.1080/15504263.2024.2329267. Epub 2024 Apr 5.

    PubMed 38580298

  • Socias ME, Cui Z, Le Foll B, Lei J, Stewart S, Anand R, Jutras-Aswad D. Sexually transmitted and blood-borne infection risk reduction with methadone and buprenorphine/naloxone among people with prescription-type opioid use disorder: Findings from a Canadian pragmatic randomized trial. HIV Med. 2024 Jul;25(7):817-825. doi: 10.1111/hiv.13636. Epub 2024 Mar 20.

    PubMed 38506171

  • Bahji A, Bastien G, Bach P, Choi J, Le Foll B, Lim R, Jutras-Aswad D, Socias ME. The Association Between Self-Reported Anxiety and Retention in Opioid Agonist Therapy: Findings From a Canadian Pragmatic Trial. Can J Psychiatry. 2024 Mar;69(3):172-182. doi: 10.1177/07067437231194385. Epub 2023 Sep 12.

    PubMed 37697811

  • Elkrief L, Bastien G, McAnulty C, Bakouni H, Hebert FO, Socias ME, Le Foll B, Lim R, Ledjiar O, Marsan S, Brissette S, Jutras-Aswad D; OPTIMA Research Group within the Canadian Research Initiative in Substance Misuse. Differential effect of cannabis use on opioid agonist treatment outcomes: Exploratory analyses from the OPTIMA study. J Subst Use Addict Treat. 2023 Jun;149:209031. doi: 10.1016/j.josat.2023.209031. Epub 2023 Mar 30.

    PubMed 37003540

  • Bastien G, McAnulty C, Ledjiar O, Socias ME, Le Foll B, Lim R, Hassan AN, Brissette S, Marsan S, Talbot A, Jutras-Aswad D; OPTIMA Research Group within the Canadian Research Initiative in Substance Misuse. Effects of Buprenorphine/Naloxone and Methadone on Depressive Symptoms in People with Prescription Opioid Use Disorder: A Pragmatic Randomised Controlled Trial. Can J Psychiatry. 2023 Aug;68(8):572-585. doi: 10.1177/07067437221145013. Epub 2022 Dec 14.

    PubMed 36519188

  • McAnulty C, Bastien G, Eugenia Socias M, Bruneau J, Le Foll B, Lim R, Brissette S, Ledjiar O, Marsan S, Talbot A, Jutras-Aswad D; OPTIMA Research Group within the Canadian Research Initiative in Substance Misuse. Buprenorphine/naloxone and methadone effectiveness for reducing craving in individuals with prescription opioid use disorder: Exploratory results from an open-label, pragmatic randomized controlled trial. Drug Alcohol Depend. 2022 Oct 1;239:109604. doi: 10.1016/j.drugalcdep.2022.109604. Epub 2022 Aug 17.

    PubMed 36037586

  • Jutras-Aswad D, Le Foll B, Ahamad K, Lim R, Bruneau J, Fischer B, Rehm J, Wild TC, Wood E, Brissette S, Gagnon L, Fikowski J, Ledjiar O, Masse B, Socias ME; OPTIMA Research Group within the Canadian Research Initiative in Substance Misuse. Flexible Buprenorphine/Naloxone Model of Care for Reducing Opioid Use in Individuals With Prescription-Type Opioid Use Disorder: An Open-Label, Pragmatic, Noninferiority Randomized Controlled Trial. Am J Psychiatry. 2022 Oct;179(10):726-739. doi: 10.1176/appi.ajp.21090964. Epub 2022 Jun 15.

    PubMed 35702828

  • Socias ME, Ahamad K, Le Foll B, Lim R, Bruneau J, Fischer B, Wild TC, Wood E, Jutras-Aswad D. The OPTIMA study, buprenorphine/naloxone and methadone models of care for the treatment of prescription opioid use disorder: Study design and rationale. Contemp Clin Trials. 2018 Jun;69:21-27. doi: 10.1016/j.cct.2018.04.001. Epub 2018 Apr 5.

    PubMed 29627621

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Methadone and Buprenorphine-Naloxone in people with Opioid Use Disorder, run by Didier Jutras Aswad at 7 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Opioid Use (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03033732, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2021.

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