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

Официальное название

A Multi-Centre, Tolerability Study of a Cannabidiol-enriched Cannabis Herbal Extract for Chronic Headaches in Adolescents: the CAN-CHA Trial

Обзор

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.

Вмешательства

• Препарат 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.

Первичные конечные точки

• Cannabis-related adverse events [Срок оценки: Reported daily through study completion, an average of 6 months]

Вторичные конечные точки (9)

• The frequency and duration of headache compared to baseline [Срок оценки: Reported daily through study completion, an average of 6 months]
• Pain intensity compared to baseline [Срок оценки: Reported daily through study completion, an average of 6 months]
• Pain impact on participants quality of life compared to baseline [Срок оценки: Reported monthly for 6 months]
• Number of hours of sleep per night compared to baseline [Срок оценки: Reported daily through study completion, an average of 6 months]
• Change in sleep quality [Срок оценки: Reported monthly for 6 months]
• Change in mood, depression from baseline [Срок оценки: Reported monthly for 6 months]
• Change in mood, positive affect from baseline [Срок оценки: Reported monthly for 6 months]
• Change in self-directed goal attainment from baseline [Срок оценки: Reported monthly for 6 months]
• Changes in anxiety compared to baseline [Срок оценки: Reported monthly for 6 months]

Критерии участия

Критерии включения

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.

Критерии исключения

• 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 a diagnosis of medication overuse headache
• Participants with cardiac, renal or hepatic disease (assessed by the site investigator)
• Participants with complex regional pain syndrome-II
• Participants with abnormal ECG findings at baseline (as determined by the investigator)
• Participants who are on the following medications: opioids, antipsychotics, antimanic, barbiturates, benzodiazepines, muscle relaxants, sedatives, or tramadol.
• Participants with developmental delay or impairments including autism, cerebral palsy or intellectual disability.
• Participants with a personal or family history of schizophrenia or psychotic disorders
• 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
• Participants with known allergy to cannabinoids and/or palm/coconut oil

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 3 центра

• University of British Columbia — Vancouver
• Dalhousie University- — Halifax
• North Toronto Neurology — Toronto

Публикации

• 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 Extr PMID 39302982

Идентификаторы

NCT: NCT05337033 · CAN-CHA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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