<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/NCT03268551</url>
  </required_header>
  <id_info>
    <org_study_id>2017-7857</org_study_id>
    <secondary_id>1R01DA044171-01A1</secondary_id>
    <nct_id>NCT03268551</nct_id>
  </id_info>
  <brief_title>MEMO-Medical Marijuana and Opioids Study</brief_title>
  <official_title>Does Medical Cannabis Reduce Opioid Analgesics in HIV+ and HIV- Adults With Pain?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Albert Einstein College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fordham University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Albert Einstein College of Medicine</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>
      The study will examine how medical cannabis use affects opioid analgesic use over time, with&#xD;
      particular attention to THC/CBD content, HIV outcomes, and severe adverse events.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overarching goal of the study is to understand how medical cannabis use affects opioid&#xD;
      analgesic use over time, with particular attention to THC/CBD content, HIV outcomes, and&#xD;
      adverse events. The study will include a cohort of 250 HIV+ and HIV- adults with (a) severe&#xD;
      or chronic pain, (b) opioid analgesic use, and (c) new certification for medical cannabis.&#xD;
      Over 18 months, participants will have 7 in-person visits every 3 months and 39 web-based&#xD;
      questionnaires every 2 weeks. Data sources will include questionnaires; medical, pharmacy,&#xD;
      and Prescription Monitoring Program records; and urine and blood samples. Over each 2-week&#xD;
      time period (unit of analysis), the primary exposure measure will be number of days of&#xD;
      medical cannabis use, and the primary outcome measure will be cumulative opioid analgesic&#xD;
      dose. Qualitative interviews will also be conducted with a subgroup of 30 participants to&#xD;
      explore perceptions of how medical cannabis use affects opioid analgesic use. Qualitative&#xD;
      findings will help understand the reasons underlying the findings of the cohort study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 4, 2018</start_date>
  <completion_date type="Actual">July 14, 2023</completion_date>
  <primary_completion_date type="Actual">July 14, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Opioid analgesic use</measure>
    <time_frame>Opioid analgesic use will be a cumulative dose of all opioid analgesics over each of the 39 2-week periods.</time_frame>
    <description>The primary outcome will combine measures of prescribed and illicit opioid analgesic use.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Alternative measures of opioid analgesic use</measure>
    <time_frame>Alternative measures of opioid analgesic use will be measured over each of the 39 2-week periods.</time_frame>
    <description>Alternative measures of opioid analgesic use will include: number of days of all opioid analgesic use, mean daily dose of all opioid analgesics, cumulative dose of prescribed (only) opioid analgesics, number of days of prescribed (only) opioid analgesic use, and mean daily dose of prescribed (only) opioid analgesic use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HIV viral load</measure>
    <time_frame>HIV outcomes will be measured seven times every 3 months from baseline through 18 months.</time_frame>
    <description>HIV viral load will be measured in copies/ml from blood samples collected during the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CD4 count</measure>
    <time_frame>CD4 count will be measured seven times every 6 months from baseline through 18 months..</time_frame>
    <description>CD4 count will be measured in cells/mm3 from blood samples collected during the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HIV antiretroviral adherence</measure>
    <time_frame>HIV antiretroviral adherence will be measured seven times every 3 months from baseline through 18 months..</time_frame>
    <description>HIV antiretroviral adherence will be a composite measure from self-reported questionnaires and pharmacy records.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HIV risk behaviors</measure>
    <time_frame>HIV risk behaviors will be measured seven times every 3 months from baseline through 18 months..</time_frame>
    <description>HIV risk behaviors will be a composite measure from self-reported questionnaires.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cannabis use disorder</measure>
    <time_frame>Cannabis use disorder will be measured three times every 6 months.</time_frame>
    <description>Cannabis use disorder will be measured using standardized instruments.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Illicit drug use</measure>
    <time_frame>Illicit drug use will be measured seven times every 3 months from baseline through 18 months..</time_frame>
    <description>Illicit drug use will be measured using standardized surveys and urine toxicology testing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diversion of medical cannabis</measure>
    <time_frame>Diversion will be measured seven times every 3 months from baseline through 18 months..</time_frame>
    <description>Diversion will be measured using standardized surveys.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-fatal overdose</measure>
    <time_frame>Non-fatal overdose will be measured seven times every 3 months from baseline through 18 months..</time_frame>
    <description>Non-fatal overdose will be measured using standardized surveys.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death</measure>
    <time_frame>Death will be measured 18 months after enrollment.</time_frame>
    <description>Death will be ascertained from the National Death Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accidents/Injuries</measure>
    <time_frame>Accident/Injuries will be measured seven times every 3 months from baseline through 18 months..</time_frame>
    <description>Accidents/Injuries will be measured using standardized survey instruments</description>
  </secondary_outcome>
  <enrollment type="Actual">257</enrollment>
  <condition>Opioid Use</condition>
  <condition>Marijuana</condition>
  <condition>Chronic Pain</condition>
  <condition>HIV/AIDS</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adults with chronic pain, who are taking opioids, and who are newly certified for medical&#xD;
        marijuana in NY.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 18 years of age&#xD;
&#xD;
          -  English or Spanish fluency&#xD;
&#xD;
          -  New certification for medical cannabis within 90 days&#xD;
&#xD;
          -  No medical cannabis use in the 6 months prior to certification&#xD;
&#xD;
          -  Medical cannabis qualifying complication of &quot;chronic or severe pain&quot;&#xD;
&#xD;
          -  Use of prescribed or illicit opioid analgesics within 30 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to provide informed consent&#xD;
&#xD;
          -  Inability to complete study visits over 18 months&#xD;
&#xD;
          -  Qualifying conditions for medical cannabis in NY that are likely to cause unique pain&#xD;
             syndromes (cancer, epilepsy, multiple sclerosis, spinal cord injury, amyotrophic&#xD;
             lateral sclerosis, Parkinson's disease, inflammatory bowel disease, Hungtington's&#xD;
             disease)&#xD;
&#xD;
          -  Terminal illness&#xD;
&#xD;
          -  Current or prior psychotic disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Montefiore Health System</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10451</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vireo Health</name>
      <address>
        <city>White Plains</city>
        <state>New York</state>
        <zip>10601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://bmjopen.bmj.com/content/10/12/e043400</url>
    <description>Medical Marijuana and Opioids (MEMO) Study: protocol of a longitudinal cohort study to examine if medical cannabis reduces opioid use among adults with chronic pain</description>
  </link>
  <link>
    <url>https://doi.org/10.1016/j.jpsychires.2021.12.001</url>
    <description>Pain catastrophizing and mental health phenotypes in adults with refractory chronic pain: A latent class analysis</description>
  </link>
  <link>
    <url>https://doi.org/10.1093/pm/pnab257</url>
    <description>First-Year Trajectories of Medical Cannabis Use Among Adults Taking Opioids for Chronic Pain: An Observational Cohort Study</description>
  </link>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>August 9, 2023</last_update_submitted>
  <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03268551
org study id: 2017-7857
secondary id: 1R01DA044171-01A1
nct id: NCT03268551
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study will examine how medical cannabis use affects opioid analgesic use over time, with
      particular attention to THC/CBD content, HIV outcomes, and severe adverse events.
The overarching goal of the study is to understand how medical cannabis use affects opioid
      analgesic use over time, with particular attention to THC/CBD content, HIV outcomes, and
      adverse events. The study will include a cohort of 250 HIV+ and HIV- adults with (a) severe
      or chronic pain, (b) opioid analgesic use, and (c) new certification for medical cannabis.
      Over 18 months, participants will have 7 in-person visits every 3 months and 39 web-based
      questionnaires every 2 weeks. Data sources will include questionnaires; medical, pharmacy,
      and Prescription Monitoring Program records; and urine and blood samples. Over each 2-week
      time period (unit of analysis), the primary exposure measure will be number of days of
      medical cannabis use, and the primary outcome measure will be cumulative opioid analgesic
      dose. Qualitative interviews will also be conducted with a subgroup of 30 participants to
      explore perceptions of how medical cannabis use affects opioid analgesic use. Qualitative
      findings will help understand the reasons underlying the findings of the cohort study.
observational model: Cohort
time perspective: Prospective
measure: Opioid analgesic use
time frame: Opioid analgesic use will be a cumulative dose of all opioid analgesics over each of the 39 2-week periods.
description: The primary outcome will combine measures of prescribed and illicit opioid analgesic use.
measure: Alternative measures of opioid analgesic use
time frame: Alternative measures of opioid analgesic use will be measured over each of the 39 2-week periods.
description: Alternative measures of opioid analgesic use will include: number of days of all opioid analgesic use, mean daily dose of all opioid analgesics, cumulative dose of prescribed (only) opioid analgesics, number of days of prescribed (only) opioid analgesic use, and mean daily dose of prescribed (only) opioid analgesic use.
measure: HIV viral load
time frame: HIV outcomes will be measured seven times every 3 months from baseline through 18 months.
description: HIV viral load will be measured in copies/ml from blood samples collected during the study.
measure: CD4 count
time frame: CD4 count will be measured seven times every 6 months from baseline through 18 months..
description: CD4 count will be measured in cells/mm3 from blood samples collected during the study.
measure: HIV antiretroviral adherence
time frame: HIV antiretroviral adherence will be measured seven times every 3 months from baseline through 18 months..
description: HIV antiretroviral adherence will be a composite measure from self-reported questionnaires and pharmacy records.
measure: HIV risk behaviors
time frame: HIV risk behaviors will be measured seven times every 3 months from baseline through 18 months..
description: HIV risk behaviors will be a composite measure from self-reported questionnaires.
measure: Cannabis use disorder
time frame: Cannabis use disorder will be measured three times every 6 months.
description: Cannabis use disorder will be measured using standardized instruments.
measure: Illicit drug use
time frame: Illicit drug use will be measured seven times every 3 months from baseline through 18 months..
description: Illicit drug use will be measured using standardized surveys and urine toxicology testing.
measure: Diversion of medical cannabis
time frame: Diversion will be measured seven times every 3 months from baseline through 18 months..
description: Diversion will be measured using standardized surveys.
measure: Non-fatal overdose
time frame: Non-fatal overdose will be measured seven times every 3 months from baseline through 18 months..
description: Non-fatal overdose will be measured using standardized surveys.
measure: Death
time frame: Death will be measured 18 months after enrollment.
description: Death will be ascertained from the National Death Index
measure: Accidents/Injuries
time frame: Accident/Injuries will be measured seven times every 3 months from baseline through 18 months..
description: Accidents/Injuries will be measured using standardized survey instruments
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: United States
url: https://bmjopen.bmj.com/content/10/12/e043400
description: Medical Marijuana and Opioids (MEMO) Study: protocol of a longitudinal cohort study to examine if medical cannabis reduces opioid use among adults with chronic pain
url: https://doi.org/10.1016/j.jpsychires.2021.12.001
description: Pain catastrophizing and mental health phenotypes in adults with refractory chronic pain: A latent class analysis
url: https://doi.org/10.1093/pm/pnab257
description: First-Year Trajectories of Medical Cannabis Use Among Adults Taking Opioids for Chronic Pain: An Observational Cohort Study
responsible party type: Sponsor
mesh term: Chronic Pain
mesh term: Marijuana Abuse