Can Medical Cannabis Affect Opioid Use?

NCT06206252 | Recruiting

• 1 other identifier: iRIS-2022-1273
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Pain

Keywords

Prescription opioids; Medical Cannabis

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (4)

• Change in quality of life

  Baseline, 4 weeks, 8 weeks, 12 weeks

• Change in mental health status

  Baseline, 4 weeks, 8 weeks, 12 weeks

• Change in sleep quality

  Baseline, 4 weeks, 8 weeks, 12 weeks

• Side effects of medical cannabis

  Baseline, 4 weeks, 8 weeks, 12 weeks

Study Arms (2)

Medical Cannabis Group

Participants will use designated medical cannabis products for the study duration.

Other: Medical Cannabis

Control Group

Participants will not use any cannabis for the study duration.

Interventions

Medical Cannabis OTHER

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.

Medical Cannabis Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Pain

Interventions

Medical Marijuana

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• Brooke Worster, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allison Herens, LSW

CONTACT

215-531-4971; mmjstudy@jefferson.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: January 16, 2024
• Study Start: September 7, 2023
• Primary Completion: May 1, 2025
• Study Completion: January 1, 2026
• Last Updated: February 14, 2025

Record last verified: 2025-02

Locations

US (1)