MEMO-Medical Marijuana and Opioids Study

• ClinicalTrials.gov Identifier: NCT03268551
• Recruitment Status: Recruiting
• First Posted: August 31, 2017
• Last Update Posted: May 13, 2021
• Sponsor: Albert Einstein College of Medicine
• Collaborators: Fordham University; Columbia University; National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): Julia H. Arnsten, Albert Einstein College of Medicine

Study Description

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.

Condition or disease
Opioid Use; Marijuana; Chronic Pain; HIV/AIDS

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 Design

• Study Type: Observational
• Estimated Enrollment: 250 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Does Medical Cannabis Reduce Opioid Analgesics in HIV+ and HIV- Adults With Pain?
• Actual Study Start Date: September 4, 2018
• Estimated Primary Completion Date: June 30, 2022
• Estimated Study Completion Date: June 30, 2022

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Opioid analgesic use [ Time Frame: 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 :

1. Alternative measures of opioid analgesic use [ Time Frame: 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.
2. HIV viral load [ Time Frame: 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.
3. CD4 count [ Time Frame: 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.
4. HIV antiretroviral adherence [ Time Frame: 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.
5. HIV risk behaviors [ Time Frame: 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.
6. Cannabis use disorder [ Time Frame: Cannabis use disorder will be measured three times every 6 months. ]
   Cannabis use disorder will be measured using standardized instruments.
7. Illicit drug use [ Time Frame: 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.
8. Diversion of medical cannabis [ Time Frame: Diversion will be measured seven times every 3 months from baseline through 18 months.. ]
   Diversion will be measured using standardized surveys.
9. Non-fatal overdose [ Time Frame: 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.
10. Death [ Time Frame: Death will be measured 18 months after enrollment. ]
    Death will be ascertained from the National Death Index
11. Accidents/Injuries [ Time Frame: Accident/Injuries will be measured seven times every 3 months from baseline through 18 months.. ]
    Accidents/Injuries will be measured using standardized survey instruments

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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.

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

Contacts and Locations

Contacts

Contact: Juia Arnsten, MD,MPH; 718-944-3848; julia.arnsten@einsteinmed.org

Contact: Giovanna DiFrancesca; 718-920-5763; giovanna.calderon@einsteinmed.org

Locations

United States, New York

Montefiore Health System; Recruiting

Bronx, New York, United States, 10451

Contact: Julia Arnsten, MD, MPH 718-944-3848 julia.arnsten@einsteinmed.org

Contact: Giovanna DiFrancesca 718-920-5763 giovanna.calderon@einsteinmed.org

Vireo Health; Recruiting

White Plains, New York, United States, 10601

Contact: Stephen Dahmer, MD 844-484-7366

Sponsors and Collaborators

Albert Einstein College of Medicine

Fordham University

Columbia University

National Institute on Drug Abuse (NIDA)

More Information

Additional Information:

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 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Julia H. Arnsten, Professor of Medicine, Albert Einstein College of Medicine
• ClinicalTrials.gov Identifier: NCT03268551
• Other Study ID Numbers: 2017-7857; 1R01DA044171-01A1 ( U.S. NIH Grant/Contract )
• First Posted: August 31, 2017
• Last Update Posted: May 13, 2021
• Last Verified: May 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Chronic Pain; Marijuana Abuse; Pain; Neurologic Manifestations; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders