Subthreshold opioid use disorder prevention (STOP) trial: a cluster randomized clinical trial: study design and methods.

"Declarations Ethics approval and consent to participateThe study was approved by the Biomedical Research Alliance of New York (BRANY). Each site’s own institutional review board ceded to the single IRB. Consent for publicationAll authors have reviewed the manuscript and have given consent for publication. The NIDA Clinical Trials Network publication committee has approved the manuscript. Competing interests“This manuscript reflects the views of the authors and may not reflect the opinions, views, and official policy or position of the U.S. Department of Health and Human Services or any of its affiliated institutions or agencies.” Dr. Subramaniam was substantially involved in this project, consistent with her role as Scientific Officer. She has no conflicts to report. Dr. Jane Liebschutz is a consultant for Biomotivate, Inc. Competing interests “This manuscript reflects the views of the authors and may not reflect the opinions, views, and official policy or position of the U.S. Department of Health and Human Services or any of its affiliated institutions or agencies.” Dr. Subramaniam was substantially involved in this project, consistent with her role as Scientific Officer. She has no conflicts to report. Dr. Jane Liebschutz is a consultant for Biomotivate, Inc."

"Funding The study is supported by the National Institutes of Health HEAL Initiative and the National Institute on Drug Abuse (NIDA) Center for Clinical Trials Network (CTN) grant for CTN 0101 as well as the following awards to CTN Sites by NIDA: Appalachian Node (UG1DA049436), New York Node (UG1DA013035), Western States Node (UG1DA015815), Mid Southern (Node UG1DA040317) and Southern California Node (UG1DA049435). The Emmes Clinical Coordinating Center was funded by Contract No. 75N95020D00012 for August 2020 to August 2025 and Contract No. HHSN271201500065C for August 2015 to August 2020. Amanda Bunting, PhD was supported by AHRQ T32 HS026120. The Emmes Data and Statistics Center was funded by Contract No. 75N95019D00013. The funders has no direct role in the conduct of the trial other than the participation of the Scientific Officer (Dr. Subramamiam) consistent with the role within NIDA clinical trials network."

"Trial Registration : Clinicaltrials.gov, identifier NCT04218201, January 6, 2020."