MEMO-Medical Marijuana and Opioids Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03268551 |
Recruitment Status :
Active, not recruiting
First Posted : August 31, 2017
Last Update Posted : August 3, 2022
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Condition or disease |
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Opioid Use Marijuana Chronic Pain HIV/AIDS |
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, 2023 |
Estimated Study Completion Date : | June 30, 2023 |

- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Death [ Time Frame: Death will be measured 18 months after enrollment. ]Death will be ascertained from the National Death Index
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03268551
United States, New York | |
Montefiore Health System | |
Bronx, New York, United States, 10451 | |
Vireo Health | |
White Plains, New York, United States, 10601 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | 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 Key Record Dates |
Last Update Posted: | August 3, 2022 |
Last Verified: | August 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Chronic Pain Marijuana Abuse Pain Neurologic Manifestations |
Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |