Can Medical Cannabis Affect Opioid Use?

Pain Clinical Trial

Official title:

The Effect of Medical Cannabis on Opioid Use for Individuals With Chronic Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06206252
• Other study ID #: iRIS-2022-1273
• Status: Recruiting
• Start date: September 7, 2023
• Est. completion date: February 2025

Study information

• Verified date: January 2024
• Source: Thomas Jefferson University
• Contact: Allison Herens, LSW
• Phone: 215-531-4971
• Email: mmjstudy[@]jefferson.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: February 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Pain

Intervention

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 compositions of medical cannabis they are using each month.

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

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