MIVetsCan: Cannabidiol (CBD)-Care Trial

Официальное название

Pragmatic Trial of Cannabidiol to Improve Chronic Pain Symptoms Among Veterans

Обзор

This research is studying the effects of cannabidiol (CBD), an active component from cannabis (a.k.a. marijuana), on Veterans' chronic pain. The purpose of this study is to better understand if CBD can improve pain symptoms in Veterans with chronic pain. Eligible participants will be randomly assigned to receive either placebo medication (not active) or CBD during the study period. The study hypotheses: \- CBD would improve overall pain symptoms compared to placebo

Вмешательства

• Препарат Placebo
  Participant will take placebo days 1-28 during study treatment. Given the pragmatic design, participants will be instructed to take the study drug whenever participants wish, with suggested starting dosing of 0.2 milliliter (mL) in the morning and 0.2mL in the evening (up to 1.2mL per day).
• Препарат Cannabidiol
  Participant will take Epidiolex days 1-28 during study treatment. Given the pragmatic design, participants will be instructed to take the study drug whenever participants wish, with suggested starting dosing of 0.2 milliliter (mL) in the morning and 0.2mL in the evening (up to 1.2mL per day).

Первичные конечные точки

• Global impression of change (PGIC) between groups at end of treatment (Day 28) [Срок оценки: Day 28]

Вторичные конечные точки (7)

• Chronic pain severity between groups in the study period (Days 1 - 28) [Срок оценки: Days 1-28]
• Change in pain interference based on the pain interference 4a short form items from the Patient Reported Outcomes Measurement Information System (PROMIS)-29+2 Profile v2.1 [Срок оценки: baseline (day 1), day 28]
• Anxiety based on the Patient Reported Outcomes Measurement Information System (PROMIS)-29+2 Profile v2.1 [Срок оценки: Days 1-28]
• Sleep disturbance based on the Patient Reported Outcomes Measurement Information System (PROMIS)-29+2 Profile v2.1 [Срок оценки: Days 1-28]
• Change in suicidal ideation based on the Negative Suicide Ideation questionnaire (PANSI) [Срок оценки: Baseline (day 1), 28]
• Change in suicidal ideation based on Positive and Negative Suicide Ideation (PANSI) Inventory [Срок оценки: Baseline (day 1), 28]
• Safety assessed by the number of adverse events that are possibly, probably, or definitely related to the study drug between groups [Срок оценки: Days 1-28]

Критерии участия

Критерии включения

• Ability to read and speak English sufficiently to allow for written informed consent and patient-reported outcomes measures
• Armed Services Veteran
• All participants must have been enrolled in the MIVetsCan Pain Registry (HUM00223894) for at least 4 weeks and agree to continue participation in that study.
• Reports moderate to severe chronic pain defined by protocol
• Currently using or interested in using cannabis for pain management
• Self-reported willingness to refrain from or not increase current Tetrahydrocannabinol (THC) or other cannabis product use (including CBD) during the study intervention or other cannabinoid use during the study intervention
• Individuals of reproductive potential must agree to use acceptable birth control per protocol
• Participants must also agree not to donate sperm or eggs during study drug administration
• Willingness to attend all study visits (may be done virtually)
• Ability to take and to swallow the study medication and be willing to adhere to the treatment regimen
• Willingness to wear Fitbit or other similar sensor for passive-data collection
• Willingness to fill out daily diary via smartphone to assess symptom status, study drug use, and other cannabis use

Критерии исключения

• Not an Armed Services Veteran
• Inability to provide informed consent (e.g., cognitive impairment, unable to sufficiently communicate in English)
• Participant reports pregnancy or are nursing
• Planning to move out of a state with legal recreational marijuana use during course of study
• Risk for imminent harm - Suicidal ideation or wish to die as assessed per protocol
• Any impairment, activity, behavior, or situation that in the judgment of the study team would prevent satisfactory completion of the study protocol
• Participation in any other clinical trials over the course of this study
• Medical or psychiatric conditions that in the judgment of study personnel would preclude participation in this study (e.g., psychosis, suicidal ideation; note that stable anxiety and depression are not exclusions)
• Having a serious or unstable hepatic disease (e.g., non-alcoholic fatty liver disease or liver cirrhosis)
• Individuals with major neurological disorders, such as dementia, Parkinson's disease, cognitive impairment, epilepsy, and seizures
• Recent/new diagnosis of cancer within the past 3 years (other than localized melanoma, localized basal cell carcinoma, localized squamous cell carcinoma treated or untreated)
• Current valproate and clobazam use per self-report or medical records
• Self-reported allergies to sesame oil or cannabis/cannabinoids

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Michigan — Ann Arbor

Публикации

• Bergmans RS, Wegryn-Jones R, Klida C, Kurtz V, Thomas L, Williams DA, Clauw DJ, Kidwell KM, Bohnert ASB, Boehnke KF. Protocol for a pragmatic trial of Cannabidiol (CBD) to improve chronic pain symptoms among United States Veterans. BMC Complement Med Ther. 2024 Jun 29;24(1):250. doi: 10.1186/s12906-024-04558-3. PMID 38951902

Идентификаторы

NCT: NCT06213233 · HUM00231202 · VMR2022-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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