MEMO-Medical Marijuana and Opioids Study

Does Medical Cannabis Reduce Opioid Analgesics in HIV+ and HIV- Adults With Pain?

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 257

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10451
      • Montefiore Health System
    • White Plains, New York, United States, 10601
      • Vireo Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid analgesic use	The primary outcome will combine measures of prescribed and illicit opioid analgesic use.	Opioid analgesic use will be a cumulative dose of all opioid analgesics over each of the 39 2-week periods.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	HIV risk behaviors will be measured seven times every 3 months from baseline through 18 months..
Cannabis use disorder	Cannabis use disorder will be measured using standardized instruments.	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.	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.	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.	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	Death will be measured 18 months after enrollment.
Accidents/Injuries	Accidents/Injuries will be measured using standardized survey instruments	Accident/Injuries will be measured seven times every 3 months from baseline through 18 months..

Collaborators and Investigators

• Sponsor: Albert Einstein College of Medicine
• Collaborators: National Institute on Drug Abuse (NIDA); Columbia University; Fordham University

Publications and helpful links

General Publications

• 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.

Helpful Links

• 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
• Pain catastrophizing and mental health phenotypes in adults with refractory chronic pain: A latent class analysis
• First-Year Trajectories of Medical Cannabis Use Among Adults Taking Opioids for Chronic Pain: An Observational Cohort Study

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2018
• Primary Completion (Actual): July 14, 2023
• Study Completion (Actual): July 14, 2023

Study Registration Dates

• First Submitted: August 23, 2017
• First Submitted That Met QC Criteria: August 29, 2017
• First Posted (Actual): August 31, 2017

Study Record Updates

• Last Update Posted (Estimated): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Pain; Neurologic Manifestations; Chronic Pain; Marijuana Abuse
• Other Study ID Numbers: 2017-7857; 1R01DA044171-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No