Clinical trial NCT05337033: Cannabis for Chronic Headaches in Adolescents: the CAN-CHA Trial
Official title: A Multi-Centre, Tolerability Study of a Cannabidiol-enriched Cannabis Herbal Extract for Chronic Headaches in Adolescents: the CAN-CHA Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Migraine
Keywords: Adolescents
Children
Cannabis
Migraine
Cannabidiol
Tetrahydrocannbinol
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: SickKids Foundation
First posted: 2022-04-20
Enrollment: 20
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label tolerability trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Cannabis-related adverse events
timeFrame: Reported daily through study completion, an average of 6 months
Secondary outcomes:
measure: The frequency and duration of headache compared to baseline
timeFrame: Reported daily through study completion, an average of 6 months
measure: Pain intensity compared to baseline
timeFrame: Reported daily through study completion, an average of 6 months
measure: Pain impact on participants quality of life compared to baseline
timeFrame: Reported monthly for 6 months
measure: Number of hours of sleep per night compared to baseline
timeFrame: Reported daily through study completion, an average of 6 months
measure: Change in sleep quality
timeFrame: Reported monthly for 6 months
measure: Change in mood, depression from baseline
timeFrame: Reported monthly for 6 months
measure: Change in mood, positive affect from baseline
timeFrame: Reported monthly for 6 months
measure: Change in self-directed goal attainment from baseline
timeFrame: Reported monthly for 6 months
measure: Changes in anxiety compared to baseline
timeFrame: Reported monthly for 6 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Halifax
country: Canada
facility: Dalhousie University-
state: Nova Scotia
city: Toronto
country: Canada
facility: North Toronto Neurology
state: Ontario
Study officials:
affiliation: University of Manitoba
name: Lauren E Kelly, PhD
role: PRINCIPAL_INVESTIGATOR
References: