Can Medical Cannabis Affect Opioid Use?
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Medical Cannabis.
- Who it may be relevant to
- Registry conditions: Chronic Pain, Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effect of Medical Cannabis on Opioid Use for Individuals with Chronic Pain
Overview
The goal of this observational study is to learn how medical cannabis (MC) affects pain and the use of opioid pain medications. Participants who have chronic pain and use prescribed opioid pain medication will opt-in to using MC or not for the 3-month study. Participants who are certified in Pennsylvania will purchase specific medical cannabis products at a reduced cost from a partnering medical cannabis dispensary monthly. All participants will complete baseline, daily, and monthly assessments to observe changes across groups.
Detailed description
The primary aim is to observe if individuals who have chronic pain that they are treating with opioids and medical cannabis report changes in pain severity, function, and opioid use compared to those who do not use medical cannabis.
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
Interventions
- Other 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
Primary outcome measures
- Change in pain severity [Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks]
- Change in pain interference [Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks]
- Change in pain [Time frame: Daily up to 12 weeks]
- Change in daily use of prescription opioids [Time frame: Daily up to 12 weeks]
Secondary outcome measures (4)
- Change in quality of life [Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks]
- Change in mental health status [Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks]
- Change in sleep quality [Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks]
- Side effects of medical cannabis [Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks]
Eligibility criteria
Inclusion criteria
- Current diagnosis of chronic, intractable pain
- 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
- Under 18 years old
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- Thomas Jefferson University Hospital — Philadelphia
Identifiers
NCT: NCT06206252 · iRIS-2022-1273