Clinical trial NCT06206252: Can Medical Cannabis Affect Opioid Use?
Official title: The Effect of Medical Cannabis on Opioid Use for Individuals with Chronic Pain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Pain
Pain
Keywords: Prescription opioids
Medical Cannabis
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 110 individuals with chronic pain who use prescribed opioids (90 medical cannabis users, 20 non-users) and live in Pennsylvania will be recruited for this study.

Brief summary: 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

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

Primary outcomes:
measure: Change in pain severity
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change in pain interference
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change in pain
timeFrame: Daily up to 12 weeks
measure: Change in daily use of prescription opioids
timeFrame: Daily up to 12 weeks
Secondary outcomes:
measure: Change in quality of life
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change in mental health status
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change in sleep quality
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Side effects of medical cannabis
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Brooke Worster, MD
role: PRINCIPAL_INVESTIGATOR
References: