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NCT Number: NCT05337033

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

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.

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Key information

Conditions

Chronic Migraine Brain Diseases Central Nervous System Diseases Chemically-Induced Disorders Headache Disorders Headache Disorders, Primary Marijuana Abuse Mental Disorders Migraine Disorders Nervous System Diseases Substance-Related Disorders

Age range

14 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of British Columbia, Vancouver, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: medical cannabis oil

Primary outcomes

  1. Cannabis-related adverse events

    Time frame: Reported daily through study completion, an average of 6 months

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

Secondary outcomes

  1. The frequency and duration of headache compared to baseline

    Time frame: Reported daily through study completion, an average of 6 months

    Reported headache frequency and duration daily and reported as a monthly average documented at baseline.

  2. Pain intensity compared to baseline

    Time frame: Reported daily through study completion, an average of 6 months

    The average intensity measured using a Numeric Rating Scale (NRS) will be reported as a percentage change from the monthly average documented at baseline and an increasing score(highest score =10) indicates a greater severity of pain.

  3. Pain impact on participants quality of life compared to baseline

    Time frame: Reported monthly for 6 months

    The impact of pain on participants quality of life using the PROMIS Pediatric Pain Interference- Short Form 8a will be reported as a percentage change from the monthly average documented at baseline.

  4. Number of hours of sleep per night compared to baseline

    Time frame: Reported daily through study completion, an average of 6 months

    The number of hours of sleep per night will be measured using a actigraphy device

  5. Change in sleep quality

    Time frame: Reported monthly for 6 months

    Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Short Form v 2.0 - Pediatric Sleep-Related Impairment 8a scale as a percentage change from the monthly average documented at baseline where a higher number indicates a more sleep related impairment

  6. Change in mood, depression from baseline

    Time frame: Reported monthly for 6 months

    PROMIS Pediatric Short Form v2.0 - Depressive Symptoms 8a scale as a percentage change from the monthly average documented at baseline

  7. Change in mood, positive affect from baseline

    Time frame: Reported monthly for 6 months

    Change in mood, positive affect will be evaluated using PROMIS Pediatric Positive Affect - Short Form 8 and reported as a percentage change from the monthly average documented at baseline

  8. Change in self-directed goal attainment from baseline

    Time frame: Reported monthly for 6 months

    Participants will self-directed goal attainment (participant and parent reported) as a percentage of goal attained at each study visit

  9. Changes in anxiety compared to baseline

    Time frame: Reported monthly for 6 months

    Changes in anxiety will be measured using the PROMIS Pediatric Anxiety Short Form v2.0 and reported as percentage change from the monthly average documented at baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Lauren E Kelly, PhD

CONTACT

[email protected]

2042723149

Lauren Kelly

CONTACT

[email protected]

2042723149

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • SickKids Foundation

Registry information

Official study title

A Multi-Centre, Tolerability Study of a Cannabidiol-enriched Cannabis Herbal Extract for Chronic Headaches in Adolescents: the CAN-CHA Trial

Acronym: CAN-CHA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 20, 2022
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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