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.
Study Type
OBSERVATIONAL
Enrollment
257
Montefiore Health System
The Bronx, New York, United States
Vireo Health
White Plains, New York, United States
Opioid analgesic use
The primary outcome will combine measures of prescribed and illicit 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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: HIV risk behaviors will be measured seven times every 3 months from baseline through 18 months..
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Cannabis use disorder
Cannabis use disorder will be measured using standardized instruments.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Death will be measured 18 months after enrollment.
Accidents/Injuries
Accidents/Injuries will be measured using standardized survey instruments
Time frame: Accident/Injuries will be measured seven times every 3 months from baseline through 18 months..