NCT05337033RecruitingPhase 2
Cannabis for Chronic Headaches in Adolescents: the CAN-CHA Trial
A Multi-Centre, Tolerability Study of a Cannabidiol-enriched Cannabis Herbal Extract for Chronic Headaches in Adolescents: the CAN-CHA Trial
Source: ClinicalTrials.gov · Last updated 29 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 29 Mar 2022
- Start date
- 11 Oct 2024
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- University of Manitoba
- Diseases
- Migraine
- NCT number
- NCT05337033
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- From 11 Oct 2024 to the primary completion date, 31 Dec 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants with a diagnosis of medication overuse headache
- Participants who are on the following medications: opioids, antipsychotics, antimanic, barbiturates, benzodiazepines, muscle relaxants, sedatives, or tramadol.
Other illness
- 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 cardiac, renal or hepatic disease (assessed by the site investigator)
- Participants with complex regional pain syndrome-II
- Participants with a personal or family history of schizophrenia or psychotic disorders
- Participants with known allergy to cannabinoids and/or palm/coconut oil
Other
- Participants with abnormal ECG findings at baseline (as determined by the investigator)
- Participants with developmental delay or impairments including autism, cerebral palsy or intellectual disability.
- 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
Who the study is looking for
- 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.
Age in the registry: 14 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dalhousie University Coordinator of this site? Confirm its status | Halifax | Canada | Not yet recruiting |
| North Toronto Neurology Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| University of British Columbia Coordinator of this site? Confirm its status | Vancouver | Canada | Not yet recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.