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Completed

NCT Number: NCT03268551

MEMO-Medical Marijuana and Opioids Study

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 18 years of age
  • English or Spanish fluency
  • New certification for medical cannabis within 90 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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Albert Einstein College of Medicine

Other

Collaborators

  • Columbia University
  • Fordham University
  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Does Medical Cannabis Reduce Opioid Analgesics in HIV+ and HIV- Adults With Pain?

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Aug 31, 2017
Registry last updated
Nov 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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