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

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Manitoba
• Collaborators: SickKids Foundation; The Canadian Collaborative for Childhood Cannabinoid Therapeutics

Criteria

Inclusion Criteria:

To be eligible to participate in this study, an individual must meet all of the following criteria:

1. Adolescents between 14-17 years of age at the time of screening

2. Diagnosed with chronic migraine for more than three months

3. Failed other treatment options on the grounds of safety (tolerability) or efficacy, including but not limited to antidepressants (tricyclic antidepressant or selective norepinephrine reuptake inhibitor), gabapentinoids or topiramate.

4. Females who have reached menarche should have a negative serum pregnancy test during screening.

5. Must be willing to engage with psychology and physiotherapy throughout the trial

Exclusion Criteria:

Adolescents meeting any of the following criteria will be excluded from the study:

1. As per investigator judgment, the participant is not an ideal candidate due to a personal issue or medical condition that is likely to impede successful completion of the study

2. Participants with a history of post-concussion headache

3. Participants with a diagnosis of medication overuse headache or tension-type headache

4. Participants with cardiac, renal, or hepatic disease (assessed by the site investigator)

5. Participants with other chronic pain conditions including complex regional pain syndrome-II

6. Participants with abnormal ECG findings at baseline

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 who are pregnant or breastfeeding or those who cannot commit to using two forms of contraception or those who plan to become pregnant within the study timeframe.

10. Participants with a family history of psychotic disorders or schizophrenia