A multi-centre, tolerability study of a cannabidiol-enriched Cannabis Herbal Extract for chronic headaches in adolescents: The CAN-CHA protocol.
Manik Chhabra, Evan C Lewis, Robert Balshaw...
https://pubmed.ncbi.nlm.nih.gov/39302982Actively Recruiting
Phase 2
Age: 14Years - 17Years
All Genders
ID05337033
A Multi-Centre, Tolerability Study of a Cannabidiol-enriched Cannabis Herbal Extract for Chronic Headaches in Adolescents: the CAN-CHA Trial
Led by University of Manitoba · Updated on 2025-05-29
20
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Manitoba
Lead Sponsor
S
SickKids Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Chronic headaches significantly impact adolescents' daily lives, and cannabis products have shown potential in managing headaches in adults. This trial evaluates a cannabidiol-enriched cannabis herbal extract in adolescents aged 14 to 17 years with chronic migraines. The study is a multisite, open-label, phase 2 tolerability study conducted across three Canadian centers, focusing on assessing the safety and tolerability of this treatment in young patients. Participants will receive a medical cannabis oil called CBD50 plus, containing 2 mg/ml delta-9-THC and 50 mg/ml CBD. The treatment lasts four months, starting with low doses of cannabidiol and gradually increasing monthly from 0.2-0.4 mg/kg/day to 0.8-1 mg/kg/day. After treatment, participants will follow a weekly dose reduction plan. The study includes a one-month baseline period before treatment begins. During the approximately six-month study, participants will report daily on headache frequency, duration, pain intensity, sleep hours, and cannabis-related adverse events. Monthly reports will assess sleep quality, mood, depression, anxiety, and goal attainment. Participants will engage with psychology and physiotherapy as appropriate. The main measure is the number and severity of adverse events related to cannabis use, monitored throughout the study.
CONDITIONS
Brief Title
Cannabis for Chronic Headaches in Adolescents: the CAN-CHA Trial
Who Can Participate
Age: 14Years - 17Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adolescents aged 14 to 17 years at screening
- Diagnosed with chronic migraine according to ICHD-3 criteria
- Headaches occurring 15 or more days per month for over 3 months, with at least 8 migraine-like days per month
- Failed at least two previous treatments due to safety or efficacy concerns
- Negative pregnancy test for females who have reached menarche
- Willing to participate in psychology and physiotherapy as appropriate during the trial
You will not qualify if you...
- Investigator judges participant unsuitable due to personal or medical reasons
- History of post-concussion headache or new daily persistent headache
- Diagnosis of medication overuse headache
- Cardiac, renal, or hepatic disease
- Complex regional pain syndrome-II
- Abnormal ECG at baseline
- Current use of opioids, antipsychotics, antimanic drugs, barbiturates, benzodiazepines, muscle relaxants, sedatives, or tramadol
- Developmental delay or impairments including autism, cerebral palsy, or intellectual disability
- Personal or family history of schizophrenia or psychotic disorders
- Pregnant, breastfeeding, or planning pregnancy during or within three months after the study
- Unable to use contraception or refrain from recreational cannabis and driving during the study
- Allergy to cannabinoids or palm/coconut oil
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 4 months
Participants receive escalating doses of cannabidiol-enriched cannabis herbal extract over four months, with dose increases every month and a weekly weaning protocol.
Monthly visits for dose increases and weekly visits for weaning assessments
Follow-up
Duration - Up to 2 months after treatment
Participants are monitored for cannabis-related adverse events, headache frequency and duration, pain intensity, quality of life, sleep patterns, mood, anxiety, and goal attainment for up to 2 additional months after treatment completion.
Monthly visits with daily and monthly symptom reporting
Trial Site Locations
Total: 3 locations
1
University of British Columbia
Vancouver, British Columbia, Canada, V6T1Z4
Not Yet Recruiting
2
Dalhousie University-
Halifax, Nova Scotia, Canada, B3K 6R8
Not Yet Recruiting
3
North Toronto Neurology
Toronto, Ontario, Canada
Actively Recruiting
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Research Team
L
Lauren E Kelly, PhD
L
Lauren Kelly
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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