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.
Brief Title
MEMO-Medical Marijuana and Opioids Study
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Opioid Use
Marijuana
Chronic Pain
HIV/AIDS
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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03268551
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2017-7857
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Does Medical Cannabis Reduce Opioid Analgesics in HIV+ and HIV- Adults With Pain?
Primary Outcomes
Outcome Description
The primary outcome will combine measures of prescribed and illicit opioid analgesic use.
Outcome Measure
Opioid analgesic use
Outcome Time Frame
Opioid analgesic use will be a cumulative dose of all opioid analgesics over each of the 39 2-week periods.
Secondary Ids
Secondary Id
1R01DA044171-01A1
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
Alternative measures of opioid analgesic use will be measured over each of the 39 2-week periods.
Outcome Measure
Alternative measures of opioid analgesic use
Outcome Description
HIV viral load will be measured in copies/ml from blood samples collected during the study.
Outcome Time Frame
HIV outcomes will be measured seven times every 3 months from baseline through 18 months.
Outcome Measure
HIV viral load
Outcome Description
CD4 count will be measured in cells/mm3 from blood samples collected during the study.
Outcome Time Frame
CD4 count will be measured seven times every 6 months from baseline through 18 months..
Outcome Measure
CD4 count
Outcome Description
HIV antiretroviral adherence will be a composite measure from self-reported questionnaires and pharmacy records.
Outcome Time Frame
HIV antiretroviral adherence will be measured seven times every 3 months from baseline through 18 months..
Outcome Measure
HIV antiretroviral adherence
Outcome Description
HIV risk behaviors will be a composite measure from self-reported questionnaires.
Outcome Time Frame
HIV risk behaviors will be measured seven times every 3 months from baseline through 18 months..
Outcome Measure
HIV risk behaviors
Outcome Description
Cannabis use disorder will be measured using standardized instruments.
Outcome Time Frame
Cannabis use disorder will be measured three times every 6 months.
Outcome Measure
Cannabis use disorder
Outcome Description
Illicit drug use will be measured using standardized surveys and urine toxicology testing.
Outcome Time Frame
Illicit drug use will be measured seven times every 3 months from baseline through 18 months..
Outcome Measure
Illicit drug use
Outcome Description
Diversion will be measured using standardized surveys.
Outcome Time Frame
Diversion will be measured seven times every 3 months from baseline through 18 months..
Outcome Measure
Diversion of medical cannabis
Outcome Description
Non-fatal overdose will be measured using standardized surveys.
Outcome Time Frame
Non-fatal overdose will be measured seven times every 3 months from baseline through 18 months..
Outcome Measure
Non-fatal overdose
Outcome Description
Death will be ascertained from the National Death Index
Outcome Time Frame
Death will be measured 18 months after enrollment.
Outcome Measure
Death
Outcome Description
Accidents/Injuries will be measured using standardized survey instruments
Outcome Time Frame
Accident/Injuries will be measured seven times every 3 months from baseline through 18 months..
Outcome Measure
Accidents/Injuries
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Adults with chronic pain, who are taking opioids, and who are newly certified for medical marijuana in NY.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Julia Arnsten
Investigator Email
julia.arnsten@einsteinmed.org
Investigator Phone
718-920-6641