Clinical trial NCT03268551: MEMO-Medical Marijuana and Opioids Study
Official title: Does Medical Cannabis Reduce Opioid Analgesics in HIV+ and HIV- Adults With Pain?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid Use
Marijuana
Chronic Pain
HIV/AIDS
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: Fordham University
name: Columbia University
name: National Institute on Drug Abuse (NIDA)
First posted: 2017-08-31
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Opioid analgesic use
timeFrame: Opioid analgesic use will be a cumulative dose of all opioid analgesics over each of the 39 2-week periods.
Secondary outcomes:
measure: Alternative measures of opioid analgesic use
timeFrame: Alternative measures of opioid analgesic use will be measured over each of the 39 2-week periods.
measure: HIV viral load
timeFrame: HIV outcomes will be measured seven times every 3 months from baseline through 18 months.
measure: CD4 count
timeFrame: CD4 count will be measured seven times every 6 months from baseline through 18 months..
measure: HIV antiretroviral adherence
timeFrame: HIV antiretroviral adherence will be measured seven times every 3 months from baseline through 18 months..
measure: HIV risk behaviors
timeFrame: HIV risk behaviors will be measured seven times every 3 months from baseline through 18 months..
measure: Cannabis use disorder
timeFrame: Cannabis use disorder will be measured three times every 6 months.
measure: Illicit drug use
timeFrame: Illicit drug use will be measured seven times every 3 months from baseline through 18 months..
measure: Diversion of medical cannabis
timeFrame: Diversion will be measured seven times every 3 months from baseline through 18 months..
measure: Non-fatal overdose
timeFrame: Non-fatal overdose will be measured seven times every 3 months from baseline through 18 months..
measure: Death
timeFrame: Death will be measured 18 months after enrollment.
measure: Accidents/Injuries
timeFrame: Accident/Injuries will be measured seven times every 3 months from baseline through 18 months..
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Health System
state: New York
city: White Plains
country: United States
facility: Vireo Health
state: New York
Study officials:
References:
citation: Cunningham CO, Starrels JL, Zhang C, Bachhuber MA, Sohler NL, Levin FR, Minami H, Slawek DE, Arnsten JH. Medical Marijuana and Opioids (MEMO) Study: protocol of a longitudinal cohort study to examine if medical cannabis reduces opioid use among adults with chronic pain. BMJ Open. 2020 Dec 29;10(12):e043400. doi: 10.1136/bmjopen-2020-043400.