Opioid UseReLeaf-ENCT04308148
Does Medical Cannabis Reduce Opioid Use in Adults With Pain
An observational study of Opioid Use and Marijuana, run by Albert Einstein College of Medicine at 1 site in United States.
Trial summary
The study will examine how medical cannabis use affects opioid analgesic use. This landmark study will be among the first to examine the effect of medical cannabis with different THC/CBD (Tetrahydrocannibinol/Cannabidiol) content on opioid use as well as adverse events. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Opioid Use, Marijuana, Chronic Pain
- How many people
- 217 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2020to 13 Mar 2024
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with chronic pain, who are taking opioids and are actively certified for medical cannabis in New York.
Who may be able to join
- At least 18 years of age
- English or Spanish fluency
- Actively certified for medical cannabis
- Intends to have a soft-gel capsule product dispensed at Vireo
- Medical cannabis qualifying conditions or complications of "chronic or severe pain" or "pain that degrades health and functional capability as an alternative to opioid use or substance use disorder"
- Joint or neuropathic pain
Show all 9Show fewer
- Current severe pain
- Dispensed opioid analgesics within the last 60 days
- To maintain the integrity of the study, we do not disclose all inclusion criteria to potential participants.
Who cannot join
- Inability to provide informed consent
- Inability to complete study visits over 14 weeks
- Terminal illness
- Current or prior psychotic disorder
- Buprenorphine or methadone treatment for opioid use disorder within the past year
- Allergies to tapioca or coconut
- Currently pregnant, planning to become pregnant within the next 3 months, or breastfeeding
- Condition that is considered by a pharmacist or medical provider to be a contraindication to medical cannabis use (e.g. unstable cardiac arrhythmia or specific drug-use interaction)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Medical Cannabis Reduce Opioid Use in Adults With Pain: An Observational Study
The study will examine how medical cannabis use affects opioid analgesic use. This landmark study will be among the first to examine the effect of medical cannabis with different THC/CBD (Tetrahydrocannibinol/Cannabidiol) content on opioid use as well as adverse events.
Read the detailed description
This study will examine how medical cannabis use affects opioid analgesic use, with particular attention to THC/CBD (Tetrahydrocannibinol/Cannabidiol) content and adverse events. We will enroll adults with (a) severe or chronic neuropathic or joint pain, (b) prescribed opioid analgesic use, (c) active certification for medical cannabis, and (d) intends to have soft gel capsule products dispensed at Vireo (medical cannabis dispensary) (including a high THC:low CBD product, an equal THC:CBD (Tetrahydrocannibinol:Cannabidiol) product, and a low THC:high CBD product). Over the 14 weeks, data sources will include questionnaires; medical, pharmacy, and Prescription Monitoring Program (PMP) records; and urine samples. The primary independent variable will be type of soft gel capsule product, and the primary outcome will be cumulative opioid analgesic dose.
- Conditions
- Opioid Use, Marijuana, Chronic Pain
- Keywords
- Opioid, Marijuana, Cannabis, Pain
- Medical subject headings
- Marijuana Abuse, Chronic Pain, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid analgesic use
The primary outcome will be opioid analgesic use.
Measured: Opioid analgesic use will be weekly cumulative dose of opioid analgesics over 14 weeks.
Secondary outcomes (1)
Adverse events
(e.g. Cannabis use disorder, illicit drug use, diversion of medical cannabis, accidents and injuries)
Measured: Adverse events will be over 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start6 Oct 2020
- Primary completion13 Mar 2024
- Study completion13 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Laura and John Arnold Foundation, Vireo Health
- Responsible party
- Sponsor
- Investigators
- Julia Arnsten, MD, MPH, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04308148
- Sponsor's protocol ID
- 2019-10029
- Other IDs
- 2019
- Acronym
- ReLeaf-E
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2020
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Medical Cannabis Reduce Opioid Use in Adults With Pain: An Observational Study
- ClinicalTrials.gov ID
- NCT04308148
- Acronym / sponsor ID
- ReLeaf-E / 2019-10029
- Conditions
- Opioid Use, Marijuana, Chronic Pain
- Keywords
- Opioid, Marijuana, Cannabis, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- Laura and John Arnold Foundation, Vireo Health
- Study start
- 6 Oct 2020 (actual)
- Primary completion
- 13 Mar 2024 (actual)
- Study completion
- 13 Mar 2024 (actual)
- First posted
- 13 Mar 2020 (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. This landmark study will be among the first to examine the effect of medical cannabis with different THC/CBD (Tetrahydrocannibinol/Cannabidiol) content on opioid use as well as adverse events.
Detailed description
This study will examine how medical cannabis use affects opioid analgesic use, with particular attention to THC/CBD (Tetrahydrocannibinol/Cannabidiol) content and adverse events. We will enroll adults with (a) severe or chronic neuropathic or joint pain, (b) prescribed opioid analgesic use, (c) active certification for medical cannabis, and (d) intends to have soft gel capsule products dispensed at Vireo (medical cannabis dispensary) (including a high THC:low CBD product, an equal THC:CBD (Tetrahydrocannibinol:Cannabidiol) product, and a low THC:high CBD product). Over the 14 weeks, data sources will include questionnaires; medical, pharmacy, and Prescription Monitoring Program (PMP) records; and urine samples. The primary independent variable will be type of soft gel capsule product, and the primary outcome will be cumulative opioid analgesic dose.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with chronic pain, who are taking opioids and are actively certified for medical cannabis in New York.
Key inclusion criteria (9 listed)
- At least 18 years of age
- English or Spanish fluency
- Actively certified for medical cannabis
- Intends to have a soft-gel capsule product dispensed at Vireo
- Medical cannabis qualifying conditions or complications of "chronic or severe pain" or "pain that degrades health and functional capability as an alternative to opioid use or substance use disorder"
Key exclusion criteria (8 listed)
- Inability to provide informed consent
- Inability to complete study visits over 14 weeks
- Terminal illness
- Current or prior psychotic disorder
- Buprenorphine or methadone treatment for opioid use disorder within the past year
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 weekly cumulative dose of opioid analgesics over 14 weeks.
The primary outcome will be opioid analgesic use.
1 secondary outcome
Adverse events
Time frame: Adverse events will be over 14 weeks
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 25 Mar 2024.
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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.
Julia Arnsten, MD, MPH principal investigator
Albert Einstein College of Medicine
1 site 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 1 site 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 9 inclusion and 8 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 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 weekly cumulative dose of opioid analgesics over 14 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2024.