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MEMO-Medical Marijuana and Opioids Study

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ClinicalTrials.gov Identifier: NCT03268551
Recruitment Status : Not yet recruiting
First Posted : August 31, 2017
Last Update Posted : March 1, 2018
Sponsor:
Collaborators:
Fordham University
Columbia University
Information provided by (Responsible Party):
Chinazo Cunningham, Albert Einstein College of Medicine, Inc.

Brief Summary:
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.

Condition or disease
Opioid Use Marijuana Chronic Pain HIV/AIDS

Detailed Description:
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.

Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Does Medical Cannabis Reduce Opioid Analgesics in HIV+ and HIV- Adults With Pain?
Estimated Study Start Date : March 1, 2018
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Marijuana
U.S. FDA Resources




Primary Outcome Measures :
  1. 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. ]
    The primary outcome will combine measures of prescribed and illicit opioid analgesic use.


Secondary Outcome Measures :
  1. 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. ]
    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.

  2. HIV viral load [ Time Frame: HIV outcomes will be measured seven times every 3 months from baseline through 18 months. ]
    HIV viral load will be measured in copies/ml from blood samples collected during the study.

  3. CD4 count [ Time Frame: CD4 count will be measured seven times every 6 months from baseline through 18 months.. ]
    CD4 count will be measured in cells/mm3 from blood samples collected during the study.

  4. HIV antiretroviral adherence [ Time Frame: HIV antiretroviral adherence will be measured seven times every 3 months from baseline through 18 months.. ]
    HIV antiretroviral adherence will be a composite measure from self-reported questionnaires and pharmacy records.

  5. HIV risk behaviors [ Time Frame: HIV risk behaviors will be measured seven times every 3 months from baseline through 18 months.. ]
    HIV risk behaviors will be a composite measure from self-reported questionnaires.

  6. Cannabis use disorder [ Time Frame: Cannabis use disorder will be measured three times every 6 months. ]
    Cannabis use disorder will be measured using standardized instruments.

  7. Illicit drug use [ Time Frame: Illicit drug use will be measured seven times every 3 months from baseline through 18 months.. ]
    Illicit drug use will be measured using standardized surveys and urine toxicology testing.

  8. Diversion of medical cannabis [ Time Frame: Diversion will be measured seven times every 3 months from baseline through 18 months.. ]
    Diversion will be measured using standardized surveys.

  9. Non-fatal overdose [ Time Frame: Non-fatal overdose will be measured seven times every 3 months from baseline through 18 months.. ]
    Non-fatal overdose will be measured using standardized surveys.

  10. Death [ Time Frame: Death will be measured 18 months after enrollment. ]
    Death will be ascertained from the National Death Index

  11. Accidents/Injuries [ Time Frame: Accident/Injuries will be measured seven times every 3 months from baseline through 18 months.. ]
    Accidents/Injuries will be measured using standardized survey instruments



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with chronic pain, who are taking opioids, and who are newly certified for medical marijuana in NY.
Criteria

Inclusion Criteria:

  • At least 18 years of age
  • English or Spanish fluency
  • New certification for medical cannabis within 30 days
  • No medical cannabis use in the 6 months prior to certification
  • Medical cannabis qualifying complication of "chronic or severe pain"
  • Use of prescribed or illicit opioid analgesics within 30 days

Exclusion Criteria:

  • Inability to provide informed consent
  • Inability to complete study visits over 18 months
  • Qualifying conditions for medical cannabis in NY that are likely to cause unique pain syndromes (cancer, epilepsy, multiple sclerosis, spinal cord injury, amyotrophic lateral sclerosis, Parkinson's disease, inflammatory bowel disease, Hungtington's disease)
  • Terminal illness
  • Current or prior psychotic disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03268551


Contacts
Contact: Chinazo Cunningham, MD,MS 718-920-5971 ccunning@montefiore.org
Contact: Giovanna DiFrancesca 718-920-5763 gcaldero@montefiore.org

Locations
United States, New York
Montefiore Health System Not yet recruiting
Bronx, New York, United States, 10451
Contact: Chinazo Cunningham, MD    718-920-5971    ccunning@montefiore.org   
Contact: Giovanna DiFracesca    718-920-5763    gcaldero@montefiore.org   
Sponsors and Collaborators
Albert Einstein College of Medicine, Inc.
Fordham University
Columbia University

Responsible Party: Chinazo Cunningham, Professor of Medicine, Albert Einstein College of Medicine, Inc.
ClinicalTrials.gov Identifier: NCT03268551     History of Changes
Other Study ID Numbers: 1R01DA044171-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Chronic Pain
Marijuana Abuse
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders