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

Phase 2RecruitingNCT05337033

University of Manitoba20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Migraine

Interventions

MPL-001

Eligibility

Sex: ALLMin age: 14 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: To be eligible to participate in this study, an individual must meet all of the following criteria: 1. Adolescents aged between 14-17 years of age at the time of screening. 2. 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. \[121\] 3. 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. 4. Females who have reached menarche should have a negative pregnancy test during screening. 5. Must be willing to engage with psychology and physiotherapy throughout the trial as appropriate. Exclusion Criteria: 1. 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 2. Participants with a history of post-concussion headache or new daily persistent headache 3. Participants with a diagnosis of medication overuse headache 4. Participants with cardiac, renal or hepatic disease (assessed by the site investigator) 5. Participants with complex regional pain syndrome-II 6. Participants with abnormal ECG findings at baseline (as determined by the investigator) 7. Participants who are on the following medications: opioids, antipsychotics, antimanic, barbiturates, benzodiazepines, muscle relaxants, sedatives, or tramadol. 8. Participants with developmental delay or impairments including autism, cerebral palsy or intellectual disability. 9. Participants with a personal or family history of schizophrenia or psychotic disorders 10. 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 11. Participants who cannot commit to using contraception and refraining from recreational cannabis use and driving throughout the study period 12. Participants with known allergy to cannabinoids and/or palm/coconut oil

Outcomes

Primary Outcomes

Cannabis-related adverse events

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

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

Secondary Outcomes

The frequency and duration of headache compared to baseline

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

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

Pain intensity compared to baseline

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.

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

Pain impact on participants quality of life compared to baseline

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.