<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/NCT04495725</url>
  </required_header>
  <id_info>
    <org_study_id>ReLeaf-V</org_study_id>
    <nct_id>NCT04495725</nct_id>
  </id_info>
  <brief_title>Do Discounted Vouchers for Medical Cannabis Reduce Opioid Use in Adults With Pain</brief_title>
  <acronym>ReLeaf-V</acronym>
  <official_title>Do Discounted Vouchers for Medical Cannabis Reduce Opioid Use in Adults With Pain: A Randomized Controlled Trial (The ReLeaf-V Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vireo Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vireo Health</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 study will examine how discounted vouchers for medical cannabis use affects opioid&#xD;
      analgesic use in adults with chronic pain. Our study findings will have critically important&#xD;
      implications to shape clinical care and medical cannabis policies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will examine how discounted vouchers for medical cannabis use affects opioid&#xD;
      analgesic use in adults with chronic pain. ReLeaf-V is a 4-arm blinded randomized controlled&#xD;
      trial (RCT) of 352 adults with (a) severe or chronic neuropathic or joint pain, (b) opioid&#xD;
      analgesic use, and (c) active certification for medical cannabis. We will randomize&#xD;
      participants to a discounted voucher for: 1) a placebo soft-gel capsule product, 2) high&#xD;
      THC:low CBD soft-gel capsule product (4.3mg THC/0.7mg CBD), 3) equal THC:CBD soft-gel capsule&#xD;
      product (2.5mg THC/2.5mg CBD), or 4) low THC:high CBD soft-gel capsule product (0.2mg&#xD;
      THC/4.8mg CBD). Over 14 weeks, participants will have 5 research visits in which data will be&#xD;
      collected from questionnaires, and medical and Prescription Monitoring Program (PMP) records.&#xD;
      The primary independent variable will be randomization arm, and the primary outcome will be&#xD;
      cumulative opioid analgesic dose.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 6, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <phase>N/A</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Opioid analgesic use</measure>
    <time_frame>Opioid analgesic use will be weekly cumulative dose of opioid analgesics over 14 weeks.</time_frame>
    <description>The primary outcome will be cumulative opioid analgesic dose.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">352</enrollment>
  <condition>Opioid Use</condition>
  <condition>Marijuana</condition>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>Voucher for a Discounted Placebo Product</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Voucher for a Discounted Placebo Soft-Gel Capsule Product</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Voucher for a Discounted High THC:Low CBD Product</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Voucher for a Discounted 4.3mg THC/0.7mg CBD Soft-Gel Capsule Product</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Voucher for a Discounted Equal THC:CBD Product</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Voucher for a Discounted 2.5mg THC/2.5mg CBD Soft-Gel Capsule Product</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Voucher for a Discounted Low THC:High CBD Product</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Voucher for a Discounted 0.2mg THC/4.8mg CBD Soft-Gel Capsule Product</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Discounted Vouchers for Medical Cannabis Soft-Gel Capsule Products</intervention_name>
    <description>We will randomize participants to one of the following four conditions for discounted vouchers: 1) a discounted voucher for a placebo soft-gel capsule product, 2) a discounted voucher for a high THC:low CBD soft-gel capsule product, 3) a discounted voucher for an equal THC:CBD soft-gel capsule product, or 4) a discounted voucher for a low THC:high CBD soft-gel capsule product. We will stratify randomization by history of cannabis use (no use in the past year, used in the past year and not near-daily or daily (used in the past year and &lt;20 days out of the last 30 days), near-daily or daily (&gt;= 20 days out of the last 30 days) baseline opioid analgesic prescription (chronic opioid treatment vs. not chronic opioid use), and primary pain condition (neuropathy, not neuropathy). Chronic opioid treatment is defined as prescribed opioids ≥90 non-overlapping days in the past 182 days. Randomization will occur in blocks to ensure equal randomization over time.</description>
    <arm_group_label>Voucher for a Discounted Equal THC:CBD Product</arm_group_label>
    <arm_group_label>Voucher for a Discounted High THC:Low CBD Product</arm_group_label>
    <arm_group_label>Voucher for a Discounted Low THC:High CBD Product</arm_group_label>
    <arm_group_label>Voucher for a Discounted Placebo Product</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. &gt;18 years old&#xD;
&#xD;
          2. English or Spanish fluency&#xD;
&#xD;
          3. active certification for medical cannabis&#xD;
&#xD;
          4. intends to have a soft-gel capsule product dispensed at Vireo Health&#xD;
&#xD;
          5. medical cannabis qualifying conditions or complications of (a) chronic pain, or (b)&#xD;
             pain that degrades health and functional capability as an alternative to opioid use or&#xD;
             substance use disorder or (c) severe or chronic pain&#xD;
&#xD;
          6. joint or neuropathic pain&#xD;
&#xD;
          7. current severe pain&#xD;
&#xD;
          8. dispensed opioids analgesics within the last 60 days&#xD;
&#xD;
        To maintain the integrity of the study, we do not disclose all inclusion criteria to&#xD;
        potential participants.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. inability to provide informed consent&#xD;
&#xD;
          2. inability to complete study visits over 14 weeks&#xD;
&#xD;
          3. terminal illness&#xD;
&#xD;
          4. current or prior psychotic disorder&#xD;
&#xD;
          5. current or prior buprenorphine or methadone treatment for opioid use disorder&#xD;
&#xD;
          6. NYS medical marijuana prescriber does not approve changes to product and dosing&#xD;
             recommendations listed on the participant's certification form&#xD;
&#xD;
          7. Allergy to tapioca or coconut&#xD;
&#xD;
          8. currently pregnant, planning to become pregnant within the next 3 months, or&#xD;
             breastfeeding&#xD;
&#xD;
          9. a condition that is considered by a pharmacist or medical provider to be a clinical&#xD;
             contraindication to medical cannabis use (e.g. unstable cardiac arrhythmia or specific&#xD;
             drug-drug interaction)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephen Dahmer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vireo Health of New York</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Stephen Dahmer, MD</last_name>
    <phone>612-999-1606</phone>
    <email>stephendahmer@vireohealth.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Olivia Uhley, BA</last_name>
    <phone>402-819-8955</phone>
    <email>oliviauhley@vireohealth.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Vireo Health of New York</name>
      <address>
        <city>Queens</city>
        <state>New York</state>
        <zip>11373</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stephen Dahmer, MD</last_name>
      <phone>612-999-1606</phone>
      <email>stephendahmer@vireohealth.com</email>
    </contact>
    <contact_backup>
      <last_name>Olivia Uhley, BA</last_name>
      <phone>402-819-8955</phone>
      <email>oliviauhley@vireohealth.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>June 29, 2022</last_update_submitted>
  <last_update_submitted_qc>June 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>opioid</keyword>
  <keyword>marijuana</keyword>
  <keyword>cannabis</keyword>
  <keyword>pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
    <mesh_term>Marijuana Abuse</mesh_term>
  </condition_browse>
  <!-- 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/NCT04495725
org study id: ReLeaf-V
nct id: NCT04495725
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will examine how discounted vouchers for medical cannabis use affects opioid
      analgesic use in adults with chronic pain. Our study findings will have critically important
      implications to shape clinical care and medical cannabis policies.
This study will examine how discounted vouchers for medical cannabis use affects opioid
      analgesic use in adults with chronic pain. ReLeaf-V is a 4-arm blinded randomized controlled
      trial (RCT) of 352 adults with (a) severe or chronic neuropathic or joint pain, (b) opioid
      analgesic use, and (c) active certification for medical cannabis. We will randomize
      participants to a discounted voucher for: 1) a placebo soft-gel capsule product, 2) high
      THC:low CBD soft-gel capsule product (4.3mg THC/0.7mg CBD), 3) equal THC:CBD soft-gel capsule
      product (2.5mg THC/2.5mg CBD), or 4) low THC:high CBD soft-gel capsule product (0.2mg
      THC/4.8mg CBD). Over 14 weeks, participants will have 5 research visits in which data will be
      collected from questionnaires, and medical and Prescription Monitoring Program (PMP) records.
      The primary independent variable will be randomization arm, and the primary outcome will be
      cumulative opioid analgesic dose.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Opioid analgesic use
time frame: Opioid analgesic use will be weekly cumulative dose of opioid analgesics over 14 weeks.
description: The primary outcome will be cumulative opioid analgesic dose.
arm group label: Voucher for a Discounted Placebo Product
arm group type: Placebo Comparator
description: Voucher for a Discounted Placebo Soft-Gel Capsule Product
arm group label: Voucher for a Discounted High THC:Low CBD Product
arm group type: Experimental
description: Voucher for a Discounted 4.3mg THC/0.7mg CBD Soft-Gel Capsule Product
arm group label: Voucher for a Discounted Equal THC:CBD Product
arm group type: Experimental
description: Voucher for a Discounted 2.5mg THC/2.5mg CBD Soft-Gel Capsule Product
arm group label: Voucher for a Discounted Low THC:High CBD Product
arm group type: Experimental
description: Voucher for a Discounted 0.2mg THC/4.8mg CBD Soft-Gel Capsule Product
intervention type: Other
intervention name: Discounted Vouchers for Medical Cannabis Soft-Gel Capsule Products
description: We will randomize participants to one of the following four conditions for discounted vouchers: 1) a discounted voucher for a placebo soft-gel capsule product, 2) a discounted voucher for a high THC:low CBD soft-gel capsule product, 3) a discounted voucher for an equal THC:CBD soft-gel capsule product, or 4) a discounted voucher for a low THC:high CBD soft-gel capsule product. We will stratify randomization by history of cannabis use (no use in the past year, used in the past year and not near-daily or daily (used in the past year and <20 days out of the last 30 days), near-daily or daily (>= 20 days out of the last 30 days) baseline opioid analgesic prescription (chronic opioid treatment vs. not chronic opioid use), and primary pain condition (neuropathy, not neuropathy). Chronic opioid treatment is defined as prescribed opioids ≥90 non-overlapping days in the past 182 days. Randomization will occur in blocks to ensure equal randomization over time.
arm group label: Voucher for a Discounted Equal THC:CBD Product
arm group label: Voucher for a Discounted High THC:Low CBD Product
arm group label: Voucher for a Discounted Low THC:High CBD Product
arm group label: Voucher for a Discounted Placebo Product
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Stephen Dahmer, MD
role: Principal Investigator
affiliation: Vireo Health of New York
last name: Stephen Dahmer, MD
phone: 612-999-1606
email: stephendahmer@vireohealth.com
last name: Olivia Uhley, BA
phone: 402-819-8955
email: oliviauhley@vireohealth.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor
mesh term: Chronic Pain
mesh term: Marijuana Abuse