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Cannabinoid

Cannabis for Chronic Headaches (CAN-CHA Trial)

Phase 1
Recruiting
Led By Lauren E Kelly, PhD
Research Sponsored by University of Manitoba
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with chronic migraine for more than three months
Adolescents between 14-17 years of age at the time of screening
Must not have
Participants with a history of post-concussion headache or new daily persistent headache
Participants who are on the following medications: opioids, antipsychotics, antimanic, barbiturates, benzodiazepines, muscle relaxants, sedatives, or tramadol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up reported monthly for 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will study the effects of cannabis on adolescents with chronic headaches. The goal is to see if it is tolerable and to document any adverse events.

Who is the study for?
Adolescents aged 14-17 with chronic migraines for over three months, who haven't found relief from other treatments like certain antidepressants or anticonvulsants. They must not have specific medical conditions that could interfere with the study, be willing to avoid pregnancy and recreational cannabis use, and commit to additional psychological and physiotherapy support.
What is being tested?
The CAN-CHA Trial is testing a Cannabidiol-enriched Cannabis Herbal Extract (MPL-001) in teens with chronic headaches. Over four months, participants will receive escalating doses of this treatment after a one-month observation period, followed by weaning off the drug. The main focus is on how well they tolerate it.
What are the potential side effects?
While the trial's primary outcome is tolerability and side effects are not explicitly listed here, common side effects of cannabidiol may include tiredness, diarrhea, changes in appetite/weight. Specifics will be 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 have been diagnosed with chronic migraine for over three months.
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I am between 14 and 17 years old.
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I am a woman of childbearing age and have a negative pregnancy test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had headaches after a concussion or experience new daily headaches.
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I am currently taking medications such as painkillers, mood stabilizers, or muscle relaxants.
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I have been diagnosed with headaches caused by overusing medication.
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I have been diagnosed with complex regional pain syndrome-II.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~reported monthly for 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and reported monthly for 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cannabis-related adverse events
Secondary study objectives
Change in mood, depression from baseline
Change in mood, positive affect from baseline
Change in self-directed goal attainment from baseline
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Cannabidiol-enriched Cannabis Herbal ExtractExperimental Treatment1 Intervention
CBD50 plus

Find a Location

Who is running the clinical trial?

The Canadian Collaborative for Childhood Cannabinoid TherapeuticsUNKNOWN
2 Previous Clinical Trials
560 Total Patients Enrolled
University of ManitobaLead Sponsor
619 Previous Clinical Trials
206,701 Total Patients Enrolled
SickKids FoundationOTHER
9 Previous Clinical Trials
2,201 Total Patients Enrolled

Media Library

CBD50 plus (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT05337033 — Phase 1
Migraine Research Study Groups: Cannabidiol-enriched Cannabis Herbal Extract
Migraine Clinical Trial 2023: CBD50 plus Highlights & Side Effects. Trial Name: NCT05337033 — Phase 1
CBD50 plus (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05337033 — Phase 1
~10 spots leftby Dec 2025
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