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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up reported monthly for 6 months
Awards & highlights

CAN-CHA Trial 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.Check my eligibility
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.See study design
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.

CAN-CHA 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.

CAN-CHA Trial 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

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

CAN-CHA 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
595 Previous Clinical Trials
199,502 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age requirement for participation in this experiment inclusive of those over 50?

"Candidates aged between 14 and 17 years old are being sought for this medical trial."

Answered by AI

What can be said about the safety profile of LGP1:20 for patients?

"Since LGP1:20 is only in Phase 1 trials, there is limited evidence for safety and efficacy so it was rated a score of 1 on our risk assessment scale."

Answered by AI

Are there any particular individuals that would be especially suitable for this study?

"This investigation seeks 20 adolescent participants aged between 14 and 17 with chronic headache. The successful applicants must have suffered from migraines for at least three months, tried other remedies (e.g., tricyclic antidepressants, gabapentinoids or topiramate) unsuccessfully, be willing to participate in psychology/physiotherapy sessions throughout the study period and females who are menarcheal should provide a negative serological pregnancy test during screening."

Answered by AI

Are enrollments still open for this research project?

"As per the clinicaltrials.gov listing, this medical trial has concluded its patient recruitment phase which began on February 1st 2023 and ended on November 16th 2022. Although not currently recruiting patients, there are still 263 other trials seeking participants at this time."

Answered by AI

Who else is applying?

What state do they live in?
New York
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
2
Recent research and studies
clinicaltrials.govStudy
Cannabis for Chronic Headaches in Adolescents: the CAN-CHA Trial
Lauren Kelly 2023. "Cannabis for Chronic Headaches in Adolescents: the CAN-CHA Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05337033.
All > Chronic Daily Headache
~13 spots leftby Dec 2025
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