A Randomised, Double-Blind, Placebo-Controlled, Parallel-Arm Study to Evaluate the Efficacy, Safety and Tolerability of 150 mg Sublingual Cannabidiol in Adults with Mild-to-Moderate Pain.
Promethean Health Pty Ltd
172 participants
Jul 5, 2023
Interventional
Conditions
Summary
Pain is extremely prevalent and highly impactful on quality of life. Both acute and chronic pain are routinely treated with paracetamol, non-steroidal anti-inflammatory drugs, monoamine reuptake inhibitors, anticonvulsant agents, and opioids. However, these treatments may have only modest efficacy in the treatment of pain and/or can have significant adverse effects that also interfere with quality of life (e.g., cognitive clouding, sedation, fatigue, weight gain). The high prevalence and high burden of disease associated with pain, combined with ineffectual treatments or treatments with significant adverse effects defines a clear unmet need for new well tolerated and effective therapeutic treatments that are not prone to abuse/misuse. This extends to the management of mild-to-moderate non-palliative pain. Cannabidiol (CBD) represents one such treatment for control of mild-to-moderate non-palliative pain. Three clinical trials and two observational studies demonstrated clear positive effects of chronic CBD dosing regimens on the management of a range of pain indications. This is a first-in-human (FIH) study for the Promethean Health CBD tablet. However, CBD been extensively investigated in human clinical trials at doses ranging from < 10 mg/day to up to 6,000 mg/day. The planned Promethean Health Pty Ltd clinical trial will investigate a total CBD daily dose of 150 mg/day for a period of 30 days. The dose level was selected within the TGA guidance for Schedule 3 registration (16). The 3 times a day dosing schedule was selected based on the half-life of the formulation (approximately 6 hours), with 3 times daily allowing the broadest dosing schedule that can be achieved through waking hours.
Eligibility
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Interventions
This is a randomised, double-blind, placebo-controlled Phase 3 registration parallel arm study to evaluate the efficacy, safety and tolerability of 150 mg Promethean Health Cannabidiol (CBD) 3 times daily, in adults experiencing mild-to-moderate pain. Promethean Health CBD Tablet is a plant-derived, highly purified CBD ((-) enantiomer (100%); minimum CBD content of greater than or equal to 98%), formulated as a nanoparticle encapsulation complexation tablet for sublingual delivery. Participants will take Promethean Health CBD tablet as oral sublingual tablets three times a day for 30 days (150 mg total daily dose), with each dose taken approximately 6 hours (± 2 hours) apart. Doses will divided as follows: • Dose 1: 2 x 30 mg tablets (60 mg total) • Dose 2: 2 x 30 mg tablets (60 mg total) • Dose 3: 1 x 30 mg tablet A total of up to 172 participants will be randomised to receive Promethean Health CBD or placebo, at a ratio of 1:1. 86 participants will receive Promethean Health CBD. During the treatment period, participants will be required to attend the clinic on days 1, 15 and 30 for study assessments. In addition participants will also be required to attend a telehealth appointment (or receive a phone call) on day 2, 8 and 22 to ascertain the use of concomitant medications and emergence of AEs, and to complete the BPI-SF, EQ-5D-5L and EQ-VAS questionnaires (Days 8 and 22 only). The end of study visit will be on Day 44. At the discretion of the site (in consultation with the participant) Days 8 and 22 may be conducted as a phone call/telehealth appointment or an in-person clinic visit. Clinical facility staff will administer the study drug only to participants included in this study following the procedures set out in this study protocol. Administration of study drugs will be recorded in the appropriate drug accountability records and the electronic case report form (eCRF). Participants will also maintain a diary to confirm the administration of the 3 doses of study drug each day. Each participant will only be given the study drug preparation carrying his/her study number.
Locations(6)
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ACTRN12623000404628