Opioid UseNCT03268551
MEMO-Medical Marijuana and Opioids Study
An observational study of Opioid Use and Marijuana, run by Albert Einstein College of Medicine at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use, Marijuana, Chronic Pain
- How many people
- 257 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Sep 2018to 14 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with chronic pain, who are taking opioids, and who are newly certified for medical marijuana in NY.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Montefiore Health System
The Bronx, New York, 10451
Vireo Health
White Plains, New York, 10601
About this study
Official title: 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.
Read the 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.
- Conditions
- Opioid Use, Marijuana, Chronic Pain, HIV/AIDS
- Medical subject headings
- Marijuana Abuse, Chronic Pain, Acquired Immunodeficiency Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid analgesic use
The primary outcome will combine measures of prescribed and illicit opioid analgesic use.
Measured: Opioid analgesic use will be a cumulative dose of all opioid analgesics over each of the 39 2-week periods.
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Death will be measured 18 months after enrollment.
Accidents/Injuries
Accidents/Injuries will be measured using standardized survey instruments
Measured: Accident/Injuries will be measured seven times every 3 months from baseline through 18 months..
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start4 Sep 2018
- Primary completion14 Jul 2023
- Study completion14 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Fordham University, Columbia University, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03268551
- Sponsor's protocol ID
- 2017-7857
- Other IDs
- 1R01DA044171-01A1
- Status last verified
- Nov 2023
- First submitted
- 23 Aug 2017
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang C, Slawek DE, Ross J, Zolotov Y, Castillo F, Levin FR, Sohler NL, Minami H, Cunningham CO, Starrels JL, Arnsten JH. Factors Associated with Medical Cannabis Use After Certification: A Three-Month Longitudinal Study. Cannabis Cannabinoid Res. 2024 Jun;9(3):e859-e869. doi: 10.1089/can.2022.0248. Epub 2023 Mar 24.
PubMed 36961410Cunningham 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.
PubMed 33376181
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Medical Cannabis Reduce Opioid Analgesics in HIV+ and HIV- Adults With Pain?
- ClinicalTrials.gov ID
- NCT03268551
- Acronym / sponsor ID
- 2017-7857
- Conditions
- Opioid Use, Marijuana, Chronic Pain, HIV/AIDS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- Fordham University, Columbia University, National Institute on Drug Abuse (NIDA)
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 14 Jul 2023 (actual)
- Study completion
- 14 Jul 2023 (actual)
- First posted
- 31 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with chronic pain, who are taking opioids, and who are newly certified for medical marijuana in NY.
Key inclusion criteria (6 listed)
- 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"
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
11 secondary outcomes
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.
HIV viral load
Time frame: HIV outcomes will be measured seven times every 3 months from baseline through 18 months.
CD4 count
Time frame: CD4 count will be measured seven times every 6 months from baseline through 18 months..
HIV antiretroviral adherence
Time frame: HIV antiretroviral adherence will be measured seven times every 3 months from baseline through 18 months..
HIV risk behaviors
Time frame: HIV risk behaviors will be measured seven times every 3 months from baseline through 18 months..
Cannabis use disorder
Time frame: Cannabis use disorder will be measured three times every 6 months.
Illicit drug use
Time frame: Illicit drug use will be measured seven times every 3 months from baseline through 18 months..
Diversion of medical cannabis
Time frame: Diversion will be measured seven times every 3 months from baseline through 18 months..
Non-fatal overdose
Time frame: Non-fatal overdose will be measured seven times every 3 months from baseline through 18 months..
Death
Time frame: Death will be measured 18 months after enrollment.
Accidents/Injuries
Time frame: Accident/Injuries will be measured seven times every 3 months from baseline through 18 months..
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Derived from this study: PubMed 36961410Zhang C, Slawek DE, Ross J, Zolotov Y, Castillo F, Levin FR, Sohler NL, Minami H, Cunningham CO, Starrels JL, Arnsten JH. Factors Associated with Medical Cannabis Use After Certification: A Three-Month Longitudinal Study. Cannabis Cannabinoid Res. 2024 Jun;9(3):e859-e869. doi: 10.1089/can.2022.0248. Epub 2023 Mar 24.
- Derived from this study: PubMed 33376181Cunningham 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.
- Medical Marijuana and Opioids (MEMO) Study: protocol of a longitudinal cohort study to examine if medical cannabis reduces opioid use among adults with chronic painLink provided by the sponsor.
- Pain catastrophizing and mental health phenotypes in adults with refractory chronic pain: A latent class analysisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Use and Marijuana, run by Albert Einstein College of Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03268551, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.