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

Conditions de participation

• Sexe:

  ALL

• Âges admissibles:

  14 to 17

Critères de participation

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:

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