Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
110 participants
OBSERVATIONAL
2023-09-07
2026-01-31
Brief Summary
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Detailed Description
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Secondary aims include observation of whether the use of medical cannabis differentially impacts tolerability (side effects, risk of cannabis use disorder), sleep-related symptoms, or quality of life and mental health among chronic opioid users.
There will be two groups, participants who are certified to use medical cannabis and those who do not use any cannabis. All participants will complete a baseline survey to report demographics, pain, sleep, mental health, well-being, quality of life, and use of medications. Some of these questions will be repeated monthly. Participants will also receive a link via text to a daily survey to report daily prescription opioid use and medical cannabis use (if applicable) as well as pain severity and interference.
Participants who purchase medical cannabis at Ethos will be randomized and restricted to one formulation of medical cannabis (vaporization or tincture) for the study duration. They will purchase three different compositions of the specific medical cannabis formulation at a reduced cost over 3 months and the order of those compositions will be randomized. They will purchase one composition per month and they will not know which one they are purchasing. The three different compositions are:
* A composition that is predominantly THC (tetrahydrocannabinol)
* A composition that is predominantly CBD (Cannabidiol)
* A composition that is a one-to-one blend of THC and CBD
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Medical Cannabis Group
Participants will use designated medical cannabis products for the study duration.
Medical Cannabis
Participants will be restricted to specific medical cannabis products from Ethos Dispensary. They will be randomized to one medical cannabis formulation (tincture or vaporization) for the duration of the study. Each month for three months, they will purchase a different composition (predominantly THC, predominantly CBD, or balanced products) of their designated formulation. The order of compositions will be randomized and double-blinded, so participants and the research team will not know which compositions of medical cannabis they are using each month.
Control Group
Participants will not use any cannabis for the study duration.
No interventions assigned to this group
Interventions
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Medical Cannabis
Participants will be restricted to specific medical cannabis products from Ethos Dispensary. They will be randomized to one medical cannabis formulation (tincture or vaporization) for the duration of the study. Each month for three months, they will purchase a different composition (predominantly THC, predominantly CBD, or balanced products) of their designated formulation. The order of compositions will be randomized and double-blinded, so participants and the research team will not know which compositions of medical cannabis they are using each month.
Eligibility Criteria
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Inclusion Criteria
* Use of prescription opioids for longer than 90 days
* Have a smartphone or agree to use one provided
* English fluency
* Medical cannabis group only: Willing to get certified by a physician to use medical cannabis in PA OR already certified but have not been using medical cannabis products regularly (daily or weekly) for longer than 30 days
* Medical cannabis group only: Willing to accept a temporary restriction on medical cannabis products
* Control group: Agree to continue not using cannabis for the duration of the study (3 months)
Exclusion Criteria
* Being under conservatorship
* Self-reported pregnant or breastfeeding
* Cannabis Use Disorder
* Active treatment in methadone or buprenorphine program for Opioid Use Disorder
* Diabetic neuropathy or chemotherapy-induced neuropathy alone
* Medical cannabis group: Cannabis use (daily/weekly) for more than 30 days
* Control group: Cannabis Use
18 Years
ALL
No
Sponsors
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Thomas Jefferson University
OTHER
Responsible Party
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Principal Investigators
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Brooke Worster, MD
Role: PRINCIPAL_INVESTIGATOR
Thomas Jefferson University
Locations
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Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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iRIS-2022-1273
Identifier Type: -
Identifier Source: org_study_id
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