<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03033732</url>
  </required_header>
  <id_info>
    <org_study_id>CRISM 001</org_study_id>
    <nct_id>NCT03033732</nct_id>
  </id_info>
  <brief_title>A Pragmatic Randomized Control Trial Comparing Models of Care in the Management of Prescription Opioid Misuse</brief_title>
  <acronym>OPTIMA</acronym>
  <official_title>Optimizing Patient Centered-Care: A Pragmatic Randomized Control Trial Comparing Models of Care in the Management of Prescription Opioid Misuse (OPTIMA Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Didier Jutras Aswad</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Canadian Research Initiative in Substance Misuse</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial evaluates two standard of care treatments for opioid addiction: methadone and&#xD;
      buprenorphine/naloxone. In order to improve patient care, the study will address real-world&#xD;
      treatment conditions, including strict regulations for methadone dosing (i.e. initially&#xD;
      dispensed daily at the pharmacy until stabilisation) vs. flexible take-home dosing for&#xD;
      buprenorphine/naloxone. The OPTIMA study is designed with the intention to support&#xD;
      patient-provider decision-making and evaluate health related outcomes with the overall aim of&#xD;
      improving treatment outcomes through enhancing patient-centered approaches in clinical care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicenter, open-label, 2-arm, randomized trial with a pragmatic design involving&#xD;
      276 individuals with prescription opioid use disorder. Participants will be randomized to&#xD;
      receive either:&#xD;
&#xD;
        1. Methadone provided via initial daily witnessed ingestion as per local guidelines.&#xD;
&#xD;
        2. Buprenorphine/naloxone maintenance therapy provided via flexible take-home dose regimens&#xD;
           dispensed as per the physician's discretion, once clinical stability is achieved.&#xD;
&#xD;
      Once randomized to a study medication and treatment initiation and induction has begun, study&#xD;
      physicians and participants will discuss the treatment plans and procedures going forward.&#xD;
      Once treatment initiation has taken place, the participant will attend study visits every 2&#xD;
      weeks (including collection of urine samples) for the 24-week intervention period. For all&#xD;
      study sites, standardized guidelines exist and will be adhered to for the safe induction of&#xD;
      both medications. Frequency of illicit opioid use, intensity of craving and other secondary&#xD;
      endpoints will also be assessed via standardized questionnaires.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2, 2017</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">March 31, 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Opioid Use</measure>
    <time_frame>24 weeks</time_frame>
    <description>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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Retention in treatment</measure>
    <time_frame>24 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid Agonist Treatment (OAT) Medication Adherence</measure>
    <time_frame>24 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety will be evaluated by monitoring adverse events (AEs) and serious adverse events (SAEs)</measure>
    <time_frame>24 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>24 weeks</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Engagement</measure>
    <time_frame>24 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Quality of life</measure>
    <time_frame>24 weeks</time_frame>
    <description>Quality of Life (QoL) will be evaluated via the EQ5-D self-report questionnaires administered at Treatment Initiation and every 4 weeks.</description>
  </other_outcome>
  <other_outcome>
    <measure>Pain</measure>
    <time_frame>24 weeks</time_frame>
    <description>Pain will be assessed via Brief Pain Inventory self-report questionnaire at Screening to determine eligibility, Treatment Initiation and every 4 weeks for the 24 week intervention period.</description>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of Participants who Initiate Taper</measure>
    <time_frame>24 weeks</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Cost-effectiveness</measure>
    <time_frame>24 weeks</time_frame>
    <description>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.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">272</enrollment>
  <condition>Opioid Use Disorder</condition>
  <arm_group>
    <arm_group_label>Methadone</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Opioid agonist treatment for opioid use disorder. Ingested in liquid oral form via strict initial daily witnessed ingestion as per local guidelines.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Buprenorphine/Naloxone</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Opioid agonist treatment for opioid use disorder. Ingested orally via sublingual tablet form, flexible take home dosing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methadone</intervention_name>
    <description>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.</description>
    <arm_group_label>Methadone</arm_group_label>
    <other_name>Methadose</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Buprenorphine-Naloxone</intervention_name>
    <description>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.</description>
    <arm_group_label>Buprenorphine/Naloxone</arm_group_label>
    <other_name>Suboxone</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Be aged between 18 and 64 years of age inclusively;&#xD;
&#xD;
          2. Prescription opioid use disorder (as defined by the Diagnostic and Statistical Manual&#xD;
             of Mental Disorders-5 criteria), which requires opioid agonist therapy as per the&#xD;
             discretion of the physician;&#xD;
&#xD;
          3. Female participants may be eligible if:&#xD;
&#xD;
               1. Is of non-childbearing potential, defined as (i) post-menopausal (12 months of&#xD;
                  spontaneous amenorrhea and ≥45 years of age); or (ii) documented surgically&#xD;
                  sterilized (i.e., tubal ligation, hysterectomy, or bilateral oophorectomy).&#xD;
&#xD;
               2. Is of childbearing potential, has a negative pregnancy test at screening and and&#xD;
                  agrees to use an acceptable method of birth control throughout study;&#xD;
&#xD;
          4. Be willing to be randomized to 24 weeks of either methadone or buprenorphine/naloxone&#xD;
             adapted model of care, and to be followed for the duration of the trial;&#xD;
&#xD;
          5. Be able to provide written informed consent;&#xD;
&#xD;
          6. Be willing to comply with study procedures;&#xD;
&#xD;
          7. Be able to communicate in English or French.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any disabling medical condition as assessed by medical history, physical exam, vital&#xD;
             signs and/or laboratory assessments that, in the opinion of the study physician,&#xD;
             precludes the safe participation in the study or the ability to provide fully informed&#xD;
             consent;&#xD;
&#xD;
          2. Any disabling, unstable or acute mental condition that in the opinion of the study&#xD;
             physician precludes safe participation in the study or ability to provide fully&#xD;
             informed consent;&#xD;
&#xD;
          3. Heroin reported as the most frequently used opioid in the past 30 days;&#xD;
&#xD;
          4. Taken methadone or buprenorphine/naloxone for Opioid Use Disorder maintenance&#xD;
             treatment in the four weeks prior to screening;&#xD;
&#xD;
          5. Pain of sufficient severity as to require ongoing pain management with opioids;&#xD;
&#xD;
          6. History of a severe adverse event, hypersensitivity reaction, or allergic reaction to&#xD;
             either methadone or buprenorphine/naloxone;&#xD;
&#xD;
          7. Pregnant, nursing, or planning to become pregnant during the study period;&#xD;
&#xD;
          8. Currently taking or have taken an investigational drug in another study in the last 30&#xD;
             days, confirmed via self-report;&#xD;
&#xD;
          9. Pending legal action or other reasons in the opinion of the study physician that might&#xD;
             prevent completion of the study;&#xD;
&#xD;
         10. Presence of a substance use disorder that, in the opinion of the study physician,&#xD;
             precludes safe participation in the study (e.g. unstable or severe alcohol use&#xD;
             disorder, unstable or severe benzodiazepine use disorder);&#xD;
&#xD;
         11. Current treatment with medications that may interact with either methadone or&#xD;
             buprenorphine/naloxone (e.g. Clonazepam, Benzodiazepines) OR anticipation that the&#xD;
             patient may need to initiate such treatment during the trial that is deemed unsafe by&#xD;
             the study physician or could prevent study completion;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Didier Jutras Aswad, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Canadian Research Initiative in Substance Misuse</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Maria E Socias, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>British Columbia Centre on Substance Use</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Keith Ahamad, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>British Columbia Centre on Substance use</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bernard LeFoll, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre for Addiction and Mental Health</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ron Lim, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Calgary</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Julie Bruneau, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre hospitalier de l'Université de Montréal (CHUM)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Evan Wood, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>British Columbia Centre on Substance Use</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Cameron Wild, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jurgen Rehm, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre for Addiction and Mental Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Calgary Opioid Dependency Program</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2R 0X7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Edmonton Opioid Dependency Program</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T5J 0G5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rapid Access Addictions Clinic-St. Paul's Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6Z 1Y6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ontario Addiction Treatment Centres- Sudbury Clinic</name>
      <address>
        <city>Sudbury</city>
        <state>Ontario</state>
        <zip>P3C 5K8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Addiction Medicine Service- Centre for Addictions and Mental Health</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M6J 1H4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre de Recherche du CHUM</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H2X 0A9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre de Recherche et d'Aide pour Narcomane</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H2X 1S7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>http://www.cihr-irsc.gc.ca/e/49683.html</url>
    <description>Related Info</description>
  </link>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>June 11, 2021</last_update_submitted>
  <last_update_submitted_qc>June 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Canadian Research Initiative in Substance Misuse</investigator_affiliation>
    <investigator_full_name>Didier Jutras Aswad</investigator_full_name>
    <investigator_title>Dr. Didier Jutras Aswad - Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>opioid agonist treatment</keyword>
  <keyword>pragmatic</keyword>
  <keyword>prescription opioid use</keyword>
  <keyword>patient engagement</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Opioid-Related Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Buprenorphine</mesh_term>
    <mesh_term>Methadone</mesh_term>
    <mesh_term>Buprenorphine, Naloxone Drug Combination</mesh_term>
    <mesh_term>Naloxone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03033732
org study id: CRISM 001
nct id: NCT03033732
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Opioid Use
time frame: 24 weeks
description: 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).
measure: Retention in treatment
time frame: 24 weeks
description: 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.
measure: Opioid Agonist Treatment (OAT) Medication Adherence
time frame: 24 weeks
description: 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.
measure: Safety will be evaluated by monitoring adverse events (AEs) and serious adverse events (SAEs)
time frame: 24 weeks
description: 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.
measure: Patient Satisfaction
time frame: 24 weeks
description: 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).
measure: Patient Engagement
time frame: 24 weeks
description: 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.
measure: Quality of life
time frame: 24 weeks
description: Quality of Life (QoL) will be evaluated via the EQ5-D self-report questionnaires administered at Treatment Initiation and every 4 weeks.
measure: Pain
time frame: 24 weeks
description: Pain will be assessed via Brief Pain Inventory self-report questionnaire at Screening to determine eligibility, Treatment Initiation and every 4 weeks for the 24 week intervention period.
measure: Proportion of Participants who Initiate Taper
time frame: 24 weeks
description: 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.
measure: Cost-effectiveness
time frame: 24 weeks
description: 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.
arm group label: Methadone
arm group type: Other
description: Opioid agonist treatment for opioid use disorder. Ingested in liquid oral form via strict initial daily witnessed ingestion as per local guidelines.
arm group label: Buprenorphine/Naloxone
arm group type: Other
description: Opioid agonist treatment for opioid use disorder. Ingested orally via sublingual tablet form, flexible take home dosing.
intervention type: Drug
intervention name: Methadone
description: 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.
arm group label: Methadone
other name: Methadose
intervention type: Drug
intervention name: Buprenorphine-Naloxone
description: 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.
arm group label: Buprenorphine/Naloxone
other name: Suboxone
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: No
last name: Didier Jutras Aswad, MD
role: Principal Investigator
affiliation: Canadian Research Initiative in Substance Misuse
last name: Maria E Socias, MD
role: Principal Investigator
affiliation: British Columbia Centre on Substance Use
last name: Keith Ahamad, MD
role: Principal Investigator
affiliation: British Columbia Centre on Substance use
last name: Bernard LeFoll, PhD
role: Principal Investigator
affiliation: Centre for Addiction and Mental Health
last name: Ron Lim, MD
role: Principal Investigator
affiliation: University of Calgary
last name: Julie Bruneau, MD
role: Principal Investigator
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
last name: Evan Wood, MD
role: Principal Investigator
affiliation: British Columbia Centre on Substance Use
last name: Cameron Wild, PhD
role: Principal Investigator
affiliation: University of Alberta
last name: Jurgen Rehm, PhD
role: Principal Investigator
affiliation: Centre for Addiction and Mental Health
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
url: http://www.cihr-irsc.gc.ca/e/49683.html
description: Related Info
responsible party type: Sponsor-Investigator
investigator affiliation: Canadian Research Initiative in Substance Misuse
investigator full name: Didier Jutras Aswad
investigator title: Dr. Didier Jutras Aswad - Principal Investigator
mesh term: Opioid-Related Disorders
mesh term: Buprenorphine
mesh term: Methadone
mesh term: Buprenorphine, Naloxone Drug Combination
mesh term: Naloxone
sharing ipd: No