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

NCT ID: NCT05337033

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-11
• Study Completion Date: 2025-12-31

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.

Conditions

Chronic Migraine

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cannabidiol-enriched Cannabis Herbal Extract

CBD50 plus

Group Type: EXPERIMENTAL

MPL-001

Intervention Type: DRUG

CBD50 plus is a medical cannabis oil with flavouring agent produced under Good Manufacturing Practice by MediPharm Labs and purchased for this study. Each ml of oil contains 2 mg/ml of delta-9-THC and 50 mg/ml of CBD.

Participants will receive escalating doses from 0.2-0.4 mg/kg/day of CBD to 0.8-1 mg/kg of CBD per day for four months, with dose increases monthly in 0.2mg/kg increments. Participants will following a weekly weaning protocol.

Interventions

MPL-001

CBD50 plus is a medical cannabis oil with flavouring agent produced under Good Manufacturing Practice by MediPharm Labs and purchased for this study. Each ml of oil contains 2 mg/ml of delta-9-THC and 50 mg/ml of CBD.

Participants will receive escalating doses from 0.2-0.4 mg/kg/day of CBD to 0.8-1 mg/kg of CBD per day for four months, with dose increases monthly in 0.2mg/kg increments. Participants will following a weekly weaning protocol.

Intervention Type: DRUG

Other Intervention Names

medical cannabis oil

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SickKids Foundation

OTHER

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Lauren Kelly

Lauren E Kelly PhD, MSc, BMedSci, CCRP, Assistant Professor, Dept. of Pediatrics & Child Health, University of Manitoba Scientific Director, Canadian Childhood Cannabinoid Clinical Trials (www.C4Trials.org)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lauren E Kelly, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

University of British Columbia

Vancouver, British Columbia, Canada

Site Status: NOT_YET_RECRUITING

Dalhousie University-

Halifax, Nova Scotia, Canada

Site Status: NOT_YET_RECRUITING

North Toronto Neurology

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Lauren E Kelly, PhD

Role: CONTACT

lauren.kelly@umanitoba.ca

2042723149

Lauren Kelly

Role: CONTACT

lauren.kelly@umanitoba.ca

2042723149

Facility Contacts

Dr. Tim Oberlander, MD, FRCPC

Role: primary

Dr. G Allen Finley, MD, FRCPC, FAAP

Role: primary

Dr. Evan C. Lewis, MD, FRCPC

Role: primary

References

Chhabra M, Lewis EC, Balshaw R, Stewart B, Zaslawski Z, Lowthian T, Alidina Z, Chesick-Gordis M, Xie W, Drogemoller BI, Wright GEB, Birnie KA, Boerner KE, Tsang VWL, Irwin SL, Pohl D, Weil AG, Sell E, Penz E, Robson-MacKay A, Mbabaali S, Blackman S, Gordon S, Alcorn J, Huntsman RJ, Oberlander TF, Finley GA, Kelly LE. A multi-centre, tolerability study of a cannabidiol-enriched Cannabis Herbal Extract for chronic headaches in adolescents: The CAN-CHA protocol. PLoS One. 2024 Sep 20;19(9):e0290185. doi: 10.1371/journal.pone.0290185. eCollection 2024.

Reference Type: DERIVED

PMID: 39302982 (View on PubMed)

Other Identifiers

CAN-CHA

Identifier Type: -

Identifier Source: org_study_id