xml: <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/NCT05985850</url>
    </required_header>
    <id_info>
      <org_study_id>BCCSU-005</org_study_id>
      <nct_id>NCT05985850</nct_id>
    </id_info>
    <brief_title>Evaluating Tetrahydrocannabinol as an Adjunct to Opioid Agonist Therapy</brief_title>
    <acronym>THC-MMT</acronym>
    <official_title>Evaluating Tetrahydrocannabinol as an Adjunct to Opioid Agonist Therapy for Individuals Living With Opioid Use Disorder: A Phase II, Placebo-controlled, Blinded, Pilot Study to Assess Safety and Feasibility (THC-MMT)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>BC Centre on Substance Use</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>BC Centre on Substance Use</source>
    <oversight_info>
      <has_dmc>No</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 pilot study will evaluate the feasibility and safety of using 1:1 tetrahydrocannabinol&#xD;
        (THC):Cannabidiol (CBD) cannabis oil as an adjunct therapy to methadone-based Opioid Agonist&#xD;
        Therapy (OAT) for individuals with opioid use disorder (OUD) in a community setting.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a single-site, two-phase pilot clinical trial evaluating the safety and feasibility&#xD;
        of administering a balanced 1:1 ratio of THC:CBD cannabis oil alongside methadone-based&#xD;
        opioid agonist therapy (OAT) in a community setting.&#xD;
  &#xD;
        Phase 1 is a 12-week, double-blind, randomized controlled study involving 24 eligible&#xD;
        participants with opioid use disorder (OUD) who recently initiated or re-initiated&#xD;
        methadone-based OAT. Participants will be randomly assigned to receive either balanced&#xD;
        THC:CBD cannabis oil or placebo oil. All participants will receive OUD clinical care,&#xD;
        including OAT management, independent of research visits.&#xD;
  &#xD;
        After the 12-week blinded treatment period (Phase 1), eligible participants will be invited&#xD;
        to Phase 2, a 12-week open-label treatment extension study with all participants receiving&#xD;
        balanced THC:CBD cannabis oil. Follow-up research visits will occur every two weeks from the&#xD;
        start of open-label treatment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2025</completion_date>
    <primary_completion_date type="Anticipated">September 2025</primary_completion_date>
    <phase>Phase 2</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>
      <intervention_model_description>Phase 1: 1:1 randomization Phase 2: Open-label</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]</measure>
      <time_frame>28 weeks</time_frame>
      <description>The safety will be evaluated by monitoring and gathering information on physical exam, vital signs, pregnancy testing, adverse events (AE) and serious adverse events (SAE), from the screening visit up to the End of Treatment (EOT)/Early Termination visit. AEs and SAEs will be monitored and recorded throughout the study duration. The proportion of participants who experience AEs or SAEs will be assessed by study arm.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Risk of Treatment Contamination</measure>
      <time_frame>24 weeks</time_frame>
      <description>The proportion of participants using non-study cannabis in the control arm, and proportion of days in Phase 1 where non-study cannabis was used. Self-report of non-study cannabis use will be collected using the Timeline Follow Back (TLFB).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Participants' adherence to treatment</measure>
      <time_frame>24 weeks</time_frame>
      <description>The degree of compliance with the recommended treatment plan, including study drug dosage and administration. This measures how well participants are able to stick to the prescribed treatment regimen and whether or not they are able to complete the full course of treatment. This will be assessed through a self-reported measure, such as study drug diary or treatment logs.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability</measure>
      <time_frame>24 weeks</time_frame>
      <description>Participant satisfaction with the assigned treatment will be assessed through administration of the Medical Safety Questionnaire (MSQ) every 4 weeks during treatment phase The MSQ is a participant-completed questionnaire that evaluates participant satisfaction with study treatment on a 7-point Likert scale.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Blinding effectiveness</measure>
      <time_frame>24 weeks</time_frame>
      <description>The blinding success questionnaire will be used to evaluate the participants' awareness of their assigned treatment.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Adequacy of Dose</measure>
      <time_frame>24 weeks</time_frame>
      <description>Patient satisfaction with dose level assessed through the adequacy of dose questionnaire and regular consultations</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The number of potential participants referred to the study</measure>
      <time_frame>24 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The screening failure rates</measure>
      <time_frame>24 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The monthly enrolment rates</measure>
      <time_frame>24 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The proportion of eligible participants who are willing to be randomized, willing to initiate the intervention and willing to complete 12-week assessments by study arm</measure>
      <time_frame>24 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The proportion of scheduled study visits completed by study arm</measure>
      <time_frame>24 weeks</time_frame>
    </secondary_outcome>
    <other_outcome>
      <measure>Retention in OAT</measure>
      <time_frame>24 weeks</time_frame>
      <description>Retention in OAT will be measured by the proportion of participants on OAT at W12 and at W24, defined as having both a) an active OAT prescription at week 12/24, and b) a positive UDT result for the prescribed OAT at week 12/24.</description>
    </other_outcome>
    <other_outcome>
      <measure>Illicit opioid use</measure>
      <time_frame>24 weeks</time_frame>
      <description>Suppression of illicit opioid use will be measured as the percentage of opioid-free weeks during W1-12, using a combination of Urine Drug Test (UDT) results and self-reported illicit opioid use assessed by the TLFB.</description>
    </other_outcome>
    <other_outcome>
      <measure>Pain Intensity</measure>
      <time_frame>24 weeks</time_frame>
      <description>The severity of pain will be assessed by the validated scale within the Patient-Reported Outcomes Measurement Information System (PROMIS) 29+2 Profile v2.1 (PROPr): the PROMIS Pain Intensity item.</description>
    </other_outcome>
    <other_outcome>
      <measure>Pain Interference</measure>
      <time_frame>24 weeks</time_frame>
      <description>The impact of pain on its impact on functioning will be assessed the validated scale within the Patient-Reported Outcomes Measurement Information System (PROMIS) 29+2 Profile v2.1 (PROPr): PROMIS SF v1.0 - Pain Interference 4a scale.</description>
    </other_outcome>
    <other_outcome>
      <measure>Anxiety</measure>
      <time_frame>24 weeks</time_frame>
      <description>Anxiety symptoms will be assessed by the validated short scale within the PROMIS 29+2 Profile v2.1 (PROPr): the PROMIS SF v1.0 - Anxiety 4a</description>
    </other_outcome>
    <other_outcome>
      <measure>Depression</measure>
      <time_frame>24 weeks</time_frame>
      <description>Depressive symptoms will be assessed by the validated short scale within the PROMIS 29+2 Profile v2.1 (PROPr): the PROMIS SF v1.0 - Depression 4a.</description>
    </other_outcome>
    <other_outcome>
      <measure>Changes in health-related quality of life</measure>
      <time_frame>24 weeks</time_frame>
      <description>Changes in health-related quality of life (HRQoL) between screening and the end of treatment will be measured by the PROMIS 29+2 Profile v2.1 (PROPr).</description>
    </other_outcome>
    <other_outcome>
      <measure>Changes in substance-use related problems</measure>
      <time_frame>24 weeks</time_frame>
      <description>The Addiction Severity Index (ASI) Self-Report form will be used to assess changes in substance-use related problems between Baseline (W0) prior to the start of treatment administration, Treatment Visit at W12 and EOT (W24)/Early Termination.</description>
    </other_outcome>
    <other_outcome>
      <measure>Opioid Craving</measure>
      <time_frame>24 weeks</time_frame>
      <description>Opioid craving over time will be measured using a 100-mm visual analog scale (VAS), with 11 lines labeled from left to right with the numbers &quot;0&quot; to &quot;10&quot;, and word anchors at each end representing the extremes, where &quot;0=no craving&quot; and &quot;100 mm=most intense craving&quot;.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Opioid Use Disorder</condition>
    <condition>Methadone</condition>
    <condition>Cannabis</condition>
    <condition>Fentanyl</condition>
    <arm_group>
      <arm_group_label>Aurora 1:1 Drops (Indica)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Aurora 1:1 Drops (Indica)&#xD;
  Balanced 1:1 ratio of THC and CBD packaged in a 30 mL bottle:&#xD;
  THC: 16.8 mg/g (+/- 15%) CBD: 16.8 mg/g (+/- 15%)&#xD;
  Induction and dosing will be ad libitum and sublingually self-administered. Initial dose will be 5 mg (equivalent to 0.25 mL)/day and participants will be able to titrate in increments of 2.5mg (0.125 mL)/day up to a maximum of 40 mg (2 mL)/day, in consultation with a study physician.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Formulated using the same medium chain triglyceride (MCT) oil as Aurora 1:1 Drops (Indica)&#xD;
  Induction and dosing will be ad libitum and sublingually self-administered. Initial dose will be 5 mg (equivalent to 0.25 mL)/day and participants will be able to titrate in increments of 2.5mg (0.125 mL)/day up to a maximum of 40 mg (2 mL)/day, in consultation with a study physician.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Aurora 1:1 Drops (Indica)</intervention_name>
      <description>Aurora 1:1 Drops (Indica) is created by extracting cannabinoids and terpenes and the concentrated extract is then diluted in medium-chain triglyceride (MCT) oil for optimal use.</description>
      <arm_group_label>Aurora 1:1 Drops (Indica)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Medium-chain triglyceride (MCT) oil with the same appearance, color, and taste as the Aurora 1:1 Drops (Indica).</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Individuals of at least 25 years of age or older;&#xD;
  &#xD;
            2. Diagnosed with OUD as per DSM-5 criteria;&#xD;
  &#xD;
            3. Initiated or re-initiated methadone-based OAT within the past 30 days prior to study&#xD;
               entry;&#xD;
  &#xD;
            4. Cannabis-use experienced, defined as having used any amount of cannabis in the six&#xD;
               months prior to the screening visit;&#xD;
  &#xD;
            5. Willing to only use study-provided cannabis as directed by study protocol, including&#xD;
               abstention from non-study cannabis and cannabinoids;&#xD;
  &#xD;
            6. Agree to keep all study medication stored in a secure location and not to&#xD;
               share/distribute study medication to any other individual;&#xD;
  &#xD;
            7. If assigned female sex at birth:&#xD;
  &#xD;
                 1. Be of non-childbearing potential, defined as (i) postmenopausal (12 months of&#xD;
                    spontaneous amenorrhea and over 45 years of age); or (ii) documented surgical&#xD;
                    sterilization (i.e., tubal ligation, hysterectomy, or bilateral oophorectomy); or&#xD;
  &#xD;
                 2. If of childbearing potential, be willing to use an acceptable method of&#xD;
                    contraception throughout the study and have a negative pregnancy test at&#xD;
                    screening;&#xD;
  &#xD;
            8. Ability to understand and comply with study protocol procedures and to provide written&#xD;
               informed consent.&#xD;
  &#xD;
          Inclusion criteria for Phase 2&#xD;
  &#xD;
          In addition to meeting all eligibility criteria outlined in Phase 1, participants will be&#xD;
          eligible for Phase 2 provided they meet ALL the following criteria at Week 12:&#xD;
  &#xD;
            1. Participants who have not experienced a study medication-related serious adverse event&#xD;
               during Phase 1;&#xD;
  &#xD;
            2. Participants who have not been lost to follow-up during Phase 1.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Any disabling, severe, or unstable medical or psychiatric condition that, in the&#xD;
               opinion of the study physician, precludes safe participation in the study or the&#xD;
               ability to provide fully informed consent, as assessed by medical and psychiatric&#xD;
               history, physical examination, vital signs, and/or laboratory tests;&#xD;
  &#xD;
            2. Any severe or unstable co-morbid substance use disorder (e.g., delirium tremens, acute&#xD;
               alcohol intoxication) that, in the opinion of the study physician, precludes safe&#xD;
               participation in the study;&#xD;
  &#xD;
            3. Currently pregnant or breastfeeding, or planning to become pregnant;&#xD;
  &#xD;
            4. Known or suspected allergy or hypersensitivity to cannabinoids;&#xD;
  &#xD;
            5. History of respiratory disease, severe cardiovascular, cerebrovascular, renal or liver&#xD;
               disease;&#xD;
  &#xD;
            6. Current or historic cannabis use disorder;&#xD;
  &#xD;
            7. Taking warfarin, clopidogrel, clobazam, theophylline, clozapine and olanzapine&#xD;
               medications as they may interact with cannabinoids in a clinically significant manner&#xD;
               if they cannot be switched to a different medication;&#xD;
  &#xD;
            8. Any personal or family history (first degree relative) of primary psychotic disorders&#xD;
               (i.e., schizophrenia, schizoaffective disorder) as per DSM-5 criteria;&#xD;
  &#xD;
            9. Unable to abstain from driving any vehicle or operating machinery for at least 10&#xD;
               hours after taking the study medication. In cases where impairment persists beyond the&#xD;
               initial 10-hour period, participants must continue to adhere to these restrictions&#xD;
               until the impairment resolves;&#xD;
  &#xD;
           10. Actively participating in other interventional clinical trial(s);&#xD;
  &#xD;
           11. Incarcerated, pending legal action or other reasons that might prevent completion of&#xD;
               the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>M Eugenia Socias, MD, MSc.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Assistant Professor, Department of Medicine, University of British Columbia</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Josie Kanu, BSc</last_name>
      <phone>6045001102</phone>
      <email>josie.kanu@bccsu.ubc.ca</email>
    </overall_contact>
    <location>
      <facility>
        <name>Rapid Access Addiction Clinic (RAAC), St. Paul's Hospital</name>
        <address>
          <city>Vancouver</city>
          <state>British Columbia</state>
          <zip>V6Z 1Y6</zip>
          <country>Canada</country>
        </address>
      </facility>
      <contact>
        <last_name>Josie Kanu, BSc</last_name>
        <phone>6045001102</phone>
        <email>josie.kanu@bccsu.ubc.ca</email>
      </contact>
      <contact_backup>
        <last_name>M. Eugenia Socias, MD, MSc</last_name>
        <email>eugenia.socias@bccsu.ubc.ca</email>
      </contact_backup>
      <investigator>
        <last_name>Sukhpreet Klaire, MD CCFP (AM)</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>BC Centre on Substance Use</investigator_affiliation>
      <investigator_full_name>M. Eugenia Socias</investigator_full_name>
      <investigator_title>Assistant Professor, Department of Medicine, UBC; Research Scientist, BCCSU</investigator_title>
    </responsible_party>
    <keyword>addiction</keyword>
    <keyword>Opioid Use Disorder</keyword>
    <keyword>Cannabis</keyword>
    <keyword>Harm Reduction</keyword>
    <keyword>Opioid</keyword>
    <keyword>Pain</keyword>
    <keyword>Quality of Life</keyword>
    <keyword>Cannabidiol</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Opioid-Related Disorders</mesh_term>
      <mesh_term>Substance-Related Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05985850
  org study id: BCCSU-005
  nct id: NCT05985850
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This pilot study will evaluate the feasibility and safety of using 1:1 tetrahydrocannabinol
        (THC):Cannabidiol (CBD) cannabis oil as an adjunct therapy to methadone-based Opioid Agonist
        Therapy (OAT) for individuals with opioid use disorder (OUD) in a community setting.
  This is a single-site, two-phase pilot clinical trial evaluating the safety and feasibility
        of administering a balanced 1:1 ratio of THC:CBD cannabis oil alongside methadone-based
        opioid agonist therapy (OAT) in a community setting.
  
        Phase 1 is a 12-week, double-blind, randomized controlled study involving 24 eligible
        participants with opioid use disorder (OUD) who recently initiated or re-initiated
        methadone-based OAT. Participants will be randomly assigned to receive either balanced
        THC:CBD cannabis oil or placebo oil. All participants will receive OUD clinical care,
        including OAT management, independent of research visits.
  
        After the 12-week blinded treatment period (Phase 1), eligible participants will be invited
        to Phase 2, a 12-week open-label treatment extension study with all participants receiving
        balanced THC:CBD cannabis oil. Follow-up research visits will occur every two weeks from the
        start of open-label treatment.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Phase 1: 1:1 randomization Phase 2: Open-label
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
  time frame: 28 weeks
  description: The safety will be evaluated by monitoring and gathering information on physical exam, vital signs, pregnancy testing, adverse events (AE) and serious adverse events (SAE), from the screening visit up to the End of Treatment (EOT)/Early Termination visit. AEs and SAEs will be monitored and recorded throughout the study duration. The proportion of participants who experience AEs or SAEs will be assessed by study arm.
  measure: Risk of Treatment Contamination
  time frame: 24 weeks
  description: The proportion of participants using non-study cannabis in the control arm, and proportion of days in Phase 1 where non-study cannabis was used. Self-report of non-study cannabis use will be collected using the Timeline Follow Back (TLFB).
  measure: Participants' adherence to treatment
  time frame: 24 weeks
  description: The degree of compliance with the recommended treatment plan, including study drug dosage and administration. This measures how well participants are able to stick to the prescribed treatment regimen and whether or not they are able to complete the full course of treatment. This will be assessed through a self-reported measure, such as study drug diary or treatment logs.
  measure: Acceptability
  time frame: 24 weeks
  description: Participant satisfaction with the assigned treatment will be assessed through administration of the Medical Safety Questionnaire (MSQ) every 4 weeks during treatment phase The MSQ is a participant-completed questionnaire that evaluates participant satisfaction with study treatment on a 7-point Likert scale.
  measure: Blinding effectiveness
  time frame: 24 weeks
  description: The blinding success questionnaire will be used to evaluate the participants' awareness of their assigned treatment.
  measure: Adequacy of Dose
  time frame: 24 weeks
  description: Patient satisfaction with dose level assessed through the adequacy of dose questionnaire and regular consultations
  measure: The number of potential participants referred to the study
  time frame: 24 weeks
  measure: The screening failure rates
  time frame: 24 weeks
  measure: The monthly enrolment rates
  time frame: 24 weeks
  measure: The proportion of eligible participants who are willing to be randomized, willing to initiate the intervention and willing to complete 12-week assessments by study arm
  time frame: 24 weeks
  measure: The proportion of scheduled study visits completed by study arm
  time frame: 24 weeks
  measure: Retention in OAT
  time frame: 24 weeks
  description: Retention in OAT will be measured by the proportion of participants on OAT at W12 and at W24, defined as having both a) an active OAT prescription at week 12/24, and b) a positive UDT result for the prescribed OAT at week 12/24.
  measure: Illicit opioid use
  time frame: 24 weeks
  description: Suppression of illicit opioid use will be measured as the percentage of opioid-free weeks during W1-12, using a combination of Urine Drug Test (UDT) results and self-reported illicit opioid use assessed by the TLFB.
  measure: Pain Intensity
  time frame: 24 weeks
  description: The severity of pain will be assessed by the validated scale within the Patient-Reported Outcomes Measurement Information System (PROMIS) 29+2 Profile v2.1 (PROPr): the PROMIS Pain Intensity item.
  measure: Pain Interference
  time frame: 24 weeks
  description: The impact of pain on its impact on functioning will be assessed the validated scale within the Patient-Reported Outcomes Measurement Information System (PROMIS) 29+2 Profile v2.1 (PROPr): PROMIS SF v1.0 - Pain Interference 4a scale.
  measure: Anxiety
  time frame: 24 weeks
  description: Anxiety symptoms will be assessed by the validated short scale within the PROMIS 29+2 Profile v2.1 (PROPr): the PROMIS SF v1.0 - Anxiety 4a
  measure: Depression
  time frame: 24 weeks
  description: Depressive symptoms will be assessed by the validated short scale within the PROMIS 29+2 Profile v2.1 (PROPr): the PROMIS SF v1.0 - Depression 4a.
  measure: Changes in health-related quality of life
  time frame: 24 weeks
  description: Changes in health-related quality of life (HRQoL) between screening and the end of treatment will be measured by the PROMIS 29+2 Profile v2.1 (PROPr).
  measure: Changes in substance-use related problems
  time frame: 24 weeks
  description: The Addiction Severity Index (ASI) Self-Report form will be used to assess changes in substance-use related problems between Baseline (W0) prior to the start of treatment administration, Treatment Visit at W12 and EOT (W24)/Early Termination.
  measure: Opioid Craving
  time frame: 24 weeks
  description: Opioid craving over time will be measured using a 100-mm visual analog scale (VAS), with 11 lines labeled from left to right with the numbers "0" to "10", and word anchors at each end representing the extremes, where "0=no craving" and "100 mm=most intense craving".
  arm group label: Aurora 1:1 Drops (Indica)
  arm group type: Experimental
  description: Aurora 1:1 Drops (Indica)
  Balanced 1:1 ratio of THC and CBD packaged in a 30 mL bottle:
  THC: 16.8 mg/g (+/- 15%) CBD: 16.8 mg/g (+/- 15%)
  Induction and dosing will be ad libitum and sublingually self-administered. Initial dose will be 5 mg (equivalent to 0.25 mL)/day and participants will be able to titrate in increments of 2.5mg (0.125 mL)/day up to a maximum of 40 mg (2 mL)/day, in consultation with a study physician.
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Formulated using the same medium chain triglyceride (MCT) oil as Aurora 1:1 Drops (Indica)
  Induction and dosing will be ad libitum and sublingually self-administered. Initial dose will be 5 mg (equivalent to 0.25 mL)/day and participants will be able to titrate in increments of 2.5mg (0.125 mL)/day up to a maximum of 40 mg (2 mL)/day, in consultation with a study physician.
  intervention type: Drug
  intervention name: Aurora 1:1 Drops (Indica)
  description: Aurora 1:1 Drops (Indica) is created by extracting cannabinoids and terpenes and the concentrated extract is then diluted in medium-chain triglyceride (MCT) oil for optimal use.
  arm group label: Aurora 1:1 Drops (Indica)
  intervention type: Drug
  intervention name: Placebo
  description: Medium-chain triglyceride (MCT) oil with the same appearance, color, and taste as the Aurora 1:1 Drops (Indica).
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 25 Years
  maximum age: N/A
  healthy volunteers: No
  last name: M Eugenia Socias, MD, MSc.
  role: Principal Investigator
  affiliation: Assistant Professor, Department of Medicine, University of British Columbia
  last name: Josie Kanu, BSc
  phone: 6045001102
  email: josie.kanu@bccsu.ubc.ca
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: Canada
  responsible party type: Principal Investigator
  investigator affiliation: BC Centre on Substance Use
  investigator full name: M. Eugenia Socias
  investigator title: Assistant Professor, Department of Medicine, UBC; Research Scientist, BCCSU
  mesh term: Opioid-Related Disorders
  mesh term: Substance-Related Disorders
  sharing ipd: No