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Cannabinoid

Oral Cannabinoids for Chronic Pain

N/A
Recruiting
Led By Hance Clarke, MD, PhD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 25 years
Experiencing chronic, non-palliative pain
Must not have
Patients who are naïve to pain treatments
Currently using Methadone or Buprenorphine
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year

Summary

This trialis testing how well cannabis works to ease chronic pain and if it's safe. Results will inform a larger trial to study the same.

Who is the study for?
This trial is for adults over 25 who can read English and have chronic pain that isn't being managed by palliative care. It's not for those who've used cannabis products recently, have allergies to cannabinoids, serious health issues like heart or liver disease, uncontrolled mental disorders, are pregnant/breastfeeding, planning a family soon, or have alcohol/substance use disorder (except opioid use disorder).
What is being tested?
The study tests the effectiveness and safety of medical cannabis in managing chronic pain. Over three months, participants will receive either CBD oil (MPL-001), a combination of CBD+THC oil (MPL-005), or a placebo to compare outcomes.
What are the potential side effects?
Potential side effects may include dizziness, dry mouth, changes in appetite or mood swings associated with cannabinoid use. The specific side effects of MPL-001 and MPL-005 will be closely monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 25 years old or older.
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I have long-term pain that is not just for comfort.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not taken any pain medication before.
Select...
I am currently taking Methadone or Buprenorphine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility outcome: pertaining to adherence to intervention
Feasibility outcome: pertaining to questionnaire data
Feasibility outcome: pertaining to the patients recruitment
+2 more
Secondary study objectives
The mean Morphine Equivalent (MEQ) dose (mg/day) at 12 weeks post-treatment for patients that were consuming opioids at the start of the trial
The mean pain interference at 12 weeks post-treatment
Other study objectives
Adverse events assessment
Assessment of symptoms of anxiety
Assessment of symptoms of depression
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: CBD+THC oilExperimental Treatment1 Intervention
Participants will receive CBD (cannabidiol) oil in combination with THC (delta-9-tetrahydrocannabinol) for a total duration of 12 weeks.
Group II: CBD oilExperimental Treatment1 Intervention
Participants will receive CBD (cannabidiol) oil for a total duration of 12 weeks.
Group III: Placebo oilPlacebo Group1 Intervention
Participants will receive matching placebo oil for a total duration of 12 weeks.

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,531 Previous Clinical Trials
504,271 Total Patients Enrolled
13 Trials studying Chronic Pain
12,557 Patients Enrolled for Chronic Pain
Hance Clarke, MD, PhDPrincipal InvestigatorToronto General Hospital, UHN
4 Previous Clinical Trials
1,372 Total Patients Enrolled
2 Trials studying Chronic Pain
280 Patients Enrolled for Chronic Pain

Media Library

CBD oil ( MPL-001) (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT05351905 — N/A
Chronic Pain Research Study Groups: Placebo oil, CBD oil, CBD+THC oil
Chronic Pain Clinical Trial 2023: CBD oil ( MPL-001) Highlights & Side Effects. Trial Name: NCT05351905 — N/A
CBD oil ( MPL-001) (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05351905 — N/A
~17 spots leftby Jan 2026
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