Cannabis for Chronic Headaches in Adolescents: the CAN-CHA Trial

NCT05337033 | Recruiting Phase 2 DMC

• 1 other identifier: CAN-CHA
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

Chronic headaches are a major cause of disability among adolescents. Cannabis products have supported the management of headaches in adults and may play a role in pediatric chronic pain. We propose a multisite, open-label, tolerability study conducted across three centers in Canada of Cannabidiol-enriched Cannabis Herbal Extract in adolescents (ages 14 to 17 years old) with chronic headaches. The study includes a one month baseline assessment, four months of escalating treatment doses and a weaning period. Our primary outcome is tolerability defined as the number and severity of reported adverse events.

Conditions

Chronic Migraine

Keywords

Adolescents; Children; Cannabis; Migraine; Cannabidiol; Tetrahydrocannbinol

Outcome Measures

Primary Outcomes (1)

• Cannabis-related adverse events

  The frequency of adverse events will be measured and characterized using standard CTCAE coding

  Reported daily through study completion, an average of 6 months

Secondary Outcomes (9)

• The frequency and duration of headache compared to baseline

  Reported daily through study completion, an average of 6 months

• Pain intensity compared to baseline

  Reported daily through study completion, an average of 6 months

• Pain impact on participants quality of life compared to baseline

  Reported monthly for 6 months

• Number of hours of sleep per night compared to baseline

  Reported daily through study completion, an average of 6 months

• Change in sleep quality

  Reported monthly for 6 months

Study Arms (1)

Cannabidiol-enriched Cannabis Herbal Extract

EXPERIMENTAL

CBD50 plus

Drug: MPL-001

Interventions

MPL-001 DRUG

CBD50 plus is a medical cannabis oil with flavouring agent produced under Good Manufacturing Practice by MediPharm Labs and purchased for this study. Each ml of oil contains 2 mg/ml of delta-9-THC and 50 mg/ml of CBD. Participants will receive escalating doses from 0.2-0.4 mg/kg/day of CBD to 0.8-1 mg/kg of CBD per day for four months, with dose increases monthly in 0.2mg/kg increments. Participants will following a weekly weaning protocol.

Also known as: medical cannabis oil

Cannabidiol-enriched Cannabis Herbal Extract

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• To be eligible to participate in this study, an individual must meet all of the following criteria:
• Adolescents aged between 14-17 years of age at the time of screening.
• Diagnosed with Chronic Migraine according to ICHD-3: headache (migraine-like or tension-type like) occurring on 15 or more days per month for more than 3 months which on at least 8 days per month have features of migraine headache. \[121\]
• Failed at least two treatment options on the grounds of safety (tolerability) and/or efficacy, including but not limited to antidepressant (tricyclic antidepressant or selective norepinephrine reuptake inhibitor), magnesium, gabapentinoids topiramate and/or non-pharmacological therapies.
• Females who have reached menarche should have a negative pregnancy test during screening.
• Must be willing to engage with psychology and physiotherapy throughout the trial as appropriate.

You may not qualify if:

• As per the investigator judgement, the participant is not an ideal candidate due to a personal issue or medical condition that is likely to impede in the successful completion of the study
• Participants with a history of post-concussion headache or new daily persistent headache
• Participants with a diagnosis of medication overuse headache
• Participants with cardiac, renal or hepatic disease (assessed by the site investigator)
• Participants with complex regional pain syndrome-II
• Participants with abnormal ECG findings at baseline (as determined by the investigator)
• Participants who are on the following medications: opioids, antipsychotics, antimanic, barbiturates, benzodiazepines, muscle relaxants, sedatives, or tramadol.
• Participants with developmental delay or impairments including autism, cerebral palsy or intellectual disability.
• Participants with a personal or family history of schizophrenia or psychotic disorders
• Participants who are pregnant or breast/chest-feeding or plans to become pregnant within the study period or within three months of interventional product discontinuation
• Participants who cannot commit to using contraception and refraining from recreational cannabis use and driving throughout the study period
• Participants with known allergy to cannabinoids and/or palm/coconut oil

Sponsors & Collaborators

• University of Manitoba: lead
• SickKids Foundation: collaborator

Study Sites (3)

University of British Columbia

Vancouver, British Columbia, V6T1Z4, Canada

NOT YET RECRUITING

Dalhousie University-

Halifax, Nova Scotia, B3K 6R8, Canada

NOT YET RECRUITING

North Toronto Neurology

Toronto, Ontario, Canada

RECRUITING

Related Publications (1)

• Chhabra M, Lewis EC, Balshaw R, Stewart B, Zaslawski Z, Lowthian T, Alidina Z, Chesick-Gordis M, Xie W, Drogemoller BI, Wright GEB, Birnie KA, Boerner KE, Tsang VWL, Irwin SL, Pohl D, Weil AG, Sell E, Penz E, Robson-MacKay A, Mbabaali S, Blackman S, Gordon S, Alcorn J, Huntsman RJ, Oberlander TF, Finley GA, Kelly LE. A multi-centre, tolerability study of a cannabidiol-enriched Cannabis Herbal Extract for chronic headaches in adolescents: The CAN-CHA protocol. PLoS One. 2024 Sep 20;19(9):e0290185. doi: 10.1371/journal.pone.0290185. eCollection 2024.

  PMID: 39302982 DERIVED

MeSH Terms

Conditions

Marijuana Abuse; Migraine Disorders

Interventions

Medical Marijuana

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• Lauren E Kelly, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren E Kelly, PhD

CONTACT

2042723149; lauren.kelly@umanitoba.ca

Lauren Kelly

CONTACT

2042723149; lauren.kelly@umanitoba.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lauren E Kelly PhD, MSc, BMedSci, CCRP, Assistant Professor, Dept. of Pediatrics & Child Health, University of Manitoba Scientific Director, Canadian Childhood Cannabinoid Clinical Trials (www.C4Trials.org)

Model Details: Open label tolerability trial

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 20, 2022
• Study Start: October 11, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)