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

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ClinicalTrials.gov Identifier: NCT03033732
Recruitment Status : Unknown
Verified March 2018 by Didier Jutras Aswad, Canadian Research Initiative in Substance Misuse.
Recruitment status was:  Recruiting
First Posted : January 27, 2017
Last Update Posted : March 9, 2018
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Didier Jutras Aswad, Canadian Research Initiative in Substance Misuse

Tracking Information
First Submitted Date  ICMJE January 10, 2017
First Posted Date  ICMJE January 27, 2017
Last Update Posted Date March 9, 2018
Actual Study Start Date  ICMJE October 2, 2017
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2017)
Opioid Use [ Time Frame: 24 weeks ]
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2018)
  • Retention in treatment [ Time Frame: 24 weeks ]
    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.
  • Opioid Agonist Treatment (OAT) Medication Adherence [ Time Frame: 24 weeks ]
    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.
  • Safety will be evaluated by monitoring adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 24 weeks ]
    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.
  • Patient Satisfaction [ Time Frame: 24 weeks ]
    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).
  • Patient Engagement [ Time Frame: 24 weeks ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2017)
  • Retention in treatment [ Time Frame: 24 weeks ]
    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.
  • Opioid Agonist Treatment Medication Adherence [ Time Frame: 24 weeks ]
    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.
  • Safety will be evaluated by monitoring adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 28 weeks (24 week intervention period + 30 days after study completion) ]
    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.
  • Patient Satisfaction [ Time Frame: 24 weeks ]
    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).
  • Patient Engagement [ Time Frame: 24 weeks ]
    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.
Current Other Pre-specified Outcome Measures
 (submitted: October 5, 2017)
  • Quality of life [ Time Frame: 24 weeks ]
    Quality of Life (QoL) will be evaluated via self-report questionnaires administered at Treatment Initiation and every 4 weeks.
  • Pain [ Time Frame: 24 weeks ]
    Pain will be assessed via self-report questionnaire at Screening to determine eligibility, Treatment Initiation and every 4 weeks for the 24 week intervention period.
  • Proportion of Participants who Initiate Taper [ Time Frame: 24 weeks ]
    The proportion of patients who initiate taper will be assessed by using a standardized induction case report form completed via both pharmacy abstraction and self-report. The pharmacy record abstraction will collect information on opioid agonist treatment use and on the days between follow up visits, as well as information on end or switching of opioid agonist treatments, missing doses and reason any change in medication status or dose change. The participant will also be asked about his/her use of opioid agonist treatments in the past 2 weeks or since the last study visit collecting information similar to that information collected in the pharmacy abstraction.
  • Cost-effectiveness [ Time Frame: 24 weeks ]
    Information on health service utilization will be collected at baseline and every 4 weeks for the 24-week intervention period. Items were selected from modules selected from the European Addiction Severity Index which collect self-report data on income, medical/medication status, healthcare provider visits, and criminal activity. This information will either be collected on paper source or entered by the participant directly into the Electronic Data Capture (EDC) system.
Original Other Pre-specified Outcome Measures
 (submitted: January 26, 2017)
  • Quality of life [ Time Frame: 24 weeks ]
    Quality of Life (QoL) will be evaluated via self-report questionnaires administered at Treatment Initiation and every 4 weeks.
  • Pain [ Time Frame: 24 weeks ]
    Pain will be assessed via self-report questionnaire at Screening to determine eligibility, Treatment Initiation and every 4 weeks for the 24 week intervention period.
  • Proportion of Participants who Initiate Taper [ Time Frame: 24 weeks ]
    The proportion of patients who initiate taper will be assessed by using a standardized induction case report form completed via both Pharmacy Abstraction and self-report.
 
Descriptive Information
Brief Title  ICMJE A Pragmatic Randomized Control Trial Comparing Models of Care in the Management of Prescription Opioid Misuse
Official Title  ICMJE Optimizing Patient Centered-Care: A Pragmatic Randomized Control Trial Comparing Models of Care in the Management of Prescription Opioid Misuse (OPTIMA Trial)
Brief 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. 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Opioid Use Disorder
Intervention  ICMJE
  • Drug: Methadone
    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.
    Other Name: Methadose
  • Drug: Buprenorphine-Naloxone
    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.
    Other Name: Suboxone
Study Arms  ICMJE
  • Methadone
    Opioid agonist treatment for opioid use disorder. Ingested in liquid oral form via strict initial daily witnessed ingestion as per local guidelines.
    Intervention: Drug: Methadone
  • Buprenorphine/Naloxone
    Opioid agonist treatment for opioid use disorder. Ingested orally via sublingual tablet form, flexible take home dosing.
    Intervention: Drug: Buprenorphine-Naloxone
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 26, 2017)
276
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Be aged between 18 and 64 years of age inclusively;
  2. 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;
  3. Female participants may be eligible if:

    1. 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).
    2. Is of childbearing potential, has a negative pregnancy test at screening and and agrees to use an acceptable method of birth control throughout study;
  4. 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;
  5. Be able to provide written informed consent;
  6. Be willing to comply with study procedures;
  7. Be able to communicate in English or French.

Exclusion Criteria:

  1. 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;
  2. 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;
  3. Heroin reported as the most frequently used opioid in the past 30 days;
  4. Taken methadone or buprenorphine/naloxone for Opioid Use Disorder maintenance treatment in the four weeks prior to screening;
  5. Pain of sufficient severity as to require ongoing pain management with opioids;
  6. History of a severe adverse event, hypersensitivity reaction, or allergic reaction to either methadone or buprenorphine/naloxone;
  7. Pregnant, nursing, or planning to become pregnant during the study period;
  8. Currently taking or have taken an investigational drug in another study in the last 30 days, confirmed via self-report;
  9. Pending legal action or other reasons in the opinion of the study physician that might prevent completion of the study;
  10. 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);
  11. 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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03033732
Other Study ID Numbers  ICMJE CRISM 001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Didier Jutras Aswad, Canadian Research Initiative in Substance Misuse
Study Sponsor  ICMJE Didier Jutras Aswad
Collaborators  ICMJE Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE
Principal Investigator: Didier Jutras Aswad, MD Canadian Research Initiative in Substance Misuse
Principal Investigator: Maria E Socias, MD British Columbia Centre on Substance Use
Principal Investigator: Keith Ahamad, MD British Columbia Centre on Substance use
Principal Investigator: Bernard LeFoll, PhD Centre for Addiction and Mental Health
Principal Investigator: Ron Lim, MD University of Calgary
Principal Investigator: Julie Bruneau, MD Centre hospitalier de l'Université de Montréal (CHUM)
Principal Investigator: Evan Wood, MD British Columbia Centre on Substance Use
Principal Investigator: Cameron Wild, PhD University of Alberta
Principal Investigator: Benedikt Fischer, PhD Centre for Addiction and Mental Health
PRS Account Canadian Research Initiative in Substance Misuse
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP