Chronic Pain, HIV/AIDS, Marijuana, Opioid Use
Conditions
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.
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.
Interventions
None listed
Sponsors
Fordham University
Columbia University
National Institute on Drug Abuse (NIDA)
Albert Einstein College of Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid analgesic use | 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
| Measure | Time frame | Description |
|---|---|---|
| HIV viral load | 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. |
| CD4 count | 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. |
| HIV antiretroviral adherence | 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. |
| HIV risk behaviors | 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. |
| Cannabis use disorder | Cannabis use disorder will be measured three times every 6 months. | Cannabis use disorder will be measured using standardized instruments. |
| Alternative measures of opioid analgesic use | 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. |
| Diversion of medical cannabis | Diversion will be measured seven times every 3 months from baseline through 18 months.. | Diversion will be measured using standardized surveys. |
| Non-fatal overdose | 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. |
| Death | Death will be measured 18 months after enrollment. | Death will be ascertained from the National Death Index |
| Accidents/Injuries | Accident/Injuries will be measured seven times every 3 months from baseline through 18 months.. | Accidents/Injuries will be measured using standardized survey instruments |
| Illicit drug use | 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. |
Countries
United States
Outcome results
None listed