A phase III multisite randomised controlled trial to compare the efficacy of cannabidiol to placebo in the treatment of cannabis use disorder: the CBD-CUD study protocol.

"Declarations Ethics approval and consent to participateEthics approval and consent to participate: Sydney Local Health District Human Research Ethics Committee, Ref: 2022/ETH02467 on 03 February 2023. The Aboriginal Health and Medical Research Council’s Human Research Ethics Committee, Ref: 2110/23 on 30 May 2023. The sites: South East Sydney Local Health District, Sydney Local Health District, Northern Sydney Local Health District, Western Sydney Local Health District, Hunter New England Local Health District and Eastern Health, Turning Point will receive site-specific ethics approval.All participants will sign a Participant Information Consent Form (PICF) before being enrolled in the study. Informed consent involves a 3-step process. (1) Verbal information about the trial is provided to the participant either face-to-face or over a telephone during the initial screen. (2) Participants eligible for a medical screen will be asked to sign a ‘medical screening consent form’ before seeing the study medical officer. (3) If the participant is deemed eligible by the study medical officer and the medical officer/ site coordinator has verbally discussed the trial to the participant and any queries or concerns addressed, the participant will sign the PICF on day 1 of commencing the trial. Consent for publicationThe participant information consent form includes a section relating to consent for de-identified data to be published. This is however not applicable for this paper. Competing interestsThe authors declare no competing interests. Competing interests The authors declare no competing interests."

"Funding This study was funded by National Health and Medical Research Council (NHMRC), Australia, project grant ID #2014980. Study drug (cannabidiol and placebo) was provided free of charge by Jazz Pharmaceuticals, UK."

"Trial registration Australian and New Zealand Clinical Trial Registry: ACTRN12623000526673 (Registered 19 May 2023)."