MEMO-Medical Marijuana and Opioids Study

Completed

• Conditions: Marijuana; Chronic Pain; HIV/AIDS; Opioid Use

• Registration Number: NCT03268551
• Lead Sponsor: Albert Einstein College of Medicine

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.

Study Timeline

• Study First Submitted: 2017-08-23
• Study First Submitted QC: 2017-08-29
• Study First Posted: 2017-08-31
• Study Start: 2018-09-04
• Primary Completion: 2023-07-14
• Study Completion: 2023-07-14
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 257

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.
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.
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.
Cannabis use disorder	Cannabis use disorder will be measured three times every 6 months.	Cannabis use disorder will be measured using standardized instruments.
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.
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.
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

Trial Locations

Locations (2)

Vireo Health; 🇺🇸 White Plains, New York, United States

Montefiore Health System; 🇺🇸 Bronx, New York, United States