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.
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
Study Type
OBSERVATIONAL
Enrollment
110
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.
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Change in pain severity
Measured using Brief Pain Inventory Short Form (BPI-SF), scores 0-10 with higher scores indicating more pain severity
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Change in pain interference
Assessed using Brief Pain Inventory Short Form (BPI-SF), scores 0-10 with higher scores indicating more pain interference
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Change in pain
Assessed using Pain, Enjoyment of Life and General Activity Scale (PEG Scale), scores 0-10 with higher scores indicating more pain
Time frame: Daily up to 12 weeks
Change in daily use of prescription opioids
Assessed using self-reported number of prescription opioids taken in last 24 hours
Time frame: Daily up to 12 weeks
Change in quality of life
Assessed using Linear Analog Scale Assessment, scores 0-10, higher scores indicating better quality of life
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Change in mental health status
Assessed using Patient Health Questionnaire-4 (PHQ-4), scores 0-12, higher scores indicating severe anxiety and depression
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Change in sleep quality
Assessed using Insomnia Severity Index (ISI), scores 0-28, higher scores indicating more severe insomnia
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
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Side effects of medical cannabis
Assessed using sum of side effects self-reported, higher scores indicating higher rates of side effects
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks