Chronic PainNCT06206252
Can Medical Cannabis Affect Opioid Use?
An observational study of Chronic Pain and Pain, run by Thomas Jefferson University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Pain
- What is being tested?
- Medical Cannabis
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2023to 2 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: The Effect of Medical Cannabis on Opioid Use for Individuals With Chronic Pain
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.
Read the 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
- Conditions
- Chronic Pain, Pain
- Being tested
- Medical Cannabis
- Keywords
- Prescription opioids, Medical Cannabis
- Medical subject headings
- Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical CannabisOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Medical Cannabis Group | Participants will use designated medical cannabis products for the study duration. Receives: Other: Medical Cannabis | |
| Control Group | Participants will not use any cannabis for the study duration. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain severity
Measured using Brief Pain Inventory Short Form (BPI-SF), scores 0-10 with higher scores indicating more pain severity
Measured: 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
Measured: 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
Measured: 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
Measured: Daily up to 12 weeks
Secondary outcomes (4)
Change in quality of life
Assessed using Linear Analog Scale Assessment, scores 0-10, higher scores indicating better quality of life
Measured: 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
Measured: 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
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Side effects of medical cannabis
Assessed using sum of side effects self-reported, higher scores indicating higher rates of side effects
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start7 Sep 2023
- Primary completion2 Dec 2025
- Study completion2 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brooke Worster, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206252
- Sponsor's protocol ID
- iRIS-2022-1273
- Status last verified
- Aug 2026
- First submitted
- 15 Jun 2023
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Medical Cannabis on Opioid Use for Individuals With Chronic Pain
- ClinicalTrials.gov ID
- NCT06206252
- Acronym / sponsor ID
- iRIS-2022-1273
- Conditions
- Chronic Pain, Pain
- Keywords
- Prescription opioids, Medical Cannabis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 7 Sep 2023 (actual)
- Primary completion
- 2 Dec 2025 (actual)
- Study completion
- 2 Dec 2025 (actual)
- First posted
- 16 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical Cannabis Group | – | Other: Medical CannabisParticipants will use designated medical cannabis products for the study duration. |
| Control Group | – | –Participants will not use any cannabis for the study duration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical CannabisParticipants 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. | Other | Medical Cannabis Group |
Primary outcome
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
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
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
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
4 secondary outcomes
Change in quality of life
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Change in mental health status
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Change in sleep quality
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Side effects of medical cannabis
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brooke Worster, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Pain, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain severity (time frame: Baseline, 4 weeks, 8 weeks, 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.