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NCT Number: NCT06206252

Can Medical Cannabis Affect Opioid Use?

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location status: Recruiting

Location contact

Allison Herens, LSW

CONTACT

[email protected]

215-531-4971

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in pain severity

    Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks

    Measured using Brief Pain Inventory Short Form (BPI-SF), scores 0-10 with higher scores indicating more pain severity

  2. Change in pain interference

    Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks

    Assessed using Brief Pain Inventory Short Form (BPI-SF), scores 0-10 with higher scores indicating more pain interference

  3. Change in pain

    Time frame: Daily up to 12 weeks

    Assessed using Pain, Enjoyment of Life and General Activity Scale (PEG Scale), scores 0-10 with higher scores indicating more pain

  4. Change in daily use of prescription opioids

    Time frame: Daily up to 12 weeks

    Assessed using self-reported number of prescription opioids taken in last 24 hours

Secondary outcomes

  1. Change in quality of life

    Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks

    Assessed using Linear Analog Scale Assessment, scores 0-10, higher scores indicating better quality of life

  2. Change in mental health status

    Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks

    Assessed using Patient Health Questionnaire-4 (PHQ-4), scores 0-12, higher scores indicating severe anxiety and depression

  3. Change in sleep quality

    Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks

    Assessed using Insomnia Severity Index (ISI), scores 0-28, higher scores indicating more severe insomnia

  4. Side effects of medical cannabis

    Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks

    Assessed using sum of side effects self-reported, higher scores indicating higher rates of side effects

Study contacts

Contact information is provided by the study sponsor or research team.

Allison Herens, LSW

CONTACT

[email protected]

215-531-4971

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jan 16, 2024
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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