MEMO-Medical Marijuana and Opioids Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Opioid Use, Marijuana, Chronic Pain, HIV/AIDS

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid analgesic use | The primary outcome will combine measures of prescribed and illicit opioid analgesic use. | Opioid analgesic use will be a cumulative dose of all opioid analgesics over each of the 39 2-week periods. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alternative measures of opioid analgesic use | 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. | Alternative measures of opioid analgesic use will be measured over each of the 39 2-week periods. | 
| HIV viral load | HIV viral load will be measured in copies/ml from blood samples collected during the study. | HIV outcomes will be measured seven times every 3 months from baseline through 18 months. | 
| CD4 count | CD4 count will be measured in cells/mm3 from blood samples collected during the study. | CD4 count will be measured seven times every 6 months from baseline through 18 months.. | 
| HIV antiretroviral adherence | HIV antiretroviral adherence will be a composite measure from self-reported questionnaires and pharmacy records. | HIV antiretroviral adherence will be measured seven times every 3 months from baseline through 18 months.. | 
| HIV risk behaviors | HIV risk behaviors will be a composite measure from self-reported questionnaires. | HIV risk behaviors will be measured seven times every 3 months from baseline through 18 months.. | 
| Cannabis use disorder | Cannabis use disorder will be measured using standardized instruments. | Cannabis use disorder will be measured three times every 6 months. | 
| Illicit drug use | Illicit drug use will be measured using standardized surveys and urine toxicology testing. | Illicit drug use will be measured seven times every 3 months from baseline through 18 months.. | 
| Diversion of medical cannabis | Diversion will be measured using standardized surveys. | Diversion will be measured seven times every 3 months from baseline through 18 months.. | 
| Non-fatal overdose | Non-fatal overdose will be measured using standardized surveys. | Non-fatal overdose will be measured seven times every 3 months from baseline through 18 months.. | 
| Death | Death will be ascertained from the National Death Index | Death will be measured 18 months after enrollment. | 
| Accidents/Injuries | Accidents/Injuries will be measured using standardized survey instruments | Accident/Injuries will be measured seven times every 3 months from baseline through 18 months.. |