MEMO-Medical Marijuana and Opioids Study

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03268551
• Other study ID #: 2017-7857
• Secondary ID: 1R01DA044171-01A
• Status: Completed
• Start date: September 4, 2018
• Est. completion date: July 14, 2023

Study information

• Verified date: November 2023
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: July 14, 2023
• Est. primary completion date: July 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• HIV/AIDS
• Marijuana
• Marijuana Abuse
• Opioid Use

Locations

Country	Name	City	State
United States	Montefiore Health System	Bronx	New York
United States	Vireo Health	White Plains	New York

Sponsors (4)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine	Columbia University, Fordham University, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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..
Secondary	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..
Secondary	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..
Secondary	Cannabis use disorder	Cannabis use disorder will be measured using standardized instruments.	Cannabis use disorder will be measured three times every 6 months.
Secondary	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..
Secondary	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..
Secondary	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..
Secondary	Death	Death will be ascertained from the National Death Index	Death will be measured 18 months after enrollment.
Secondary	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..

External Links

•   First-Year Trajectories of Medical Cannabis Use Among Adults Taking Opioids for Chronic Pain: An Observational Cohort Study
•   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