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Article History

Received: 12 November 2024

Accepted: 18 April 2025

First Online: 8 May 2025

Declarations

:

: The protocol was approved by the National Institute of Drug Abuse (NIDA) Center for Clinical Trials Network (CCTN), Medical University of South Carolina (MUSC) Institutional Review Board (IRB), as well as University of Texas Southwestern (UTSW), UT Health San Antonio, and Wake Forest University IRB (CTN Protocol ID: CTN-0108; ClinicalTrials.gov ID: NCT04907357). Informed consent was obtained in writing, voluntarily, from participants by designated study research staff. A copy of the consent form can be accessed at ClinicalTrials.gov.

: Not applicable.

: Dr. Geetha Subramaniam is an employee of the National Institute on Drug Abuse (NIDA), which is the funding agency for the study. She was substantially involved in this study, consistent with her role as NIDA Scientific Officer. She has no other conflicts to report. 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. Manish Kumar Jha has received contract research grants from Acadia Pharmaceuticals, Neurocrine Bioscience, Navitor/Supernus and Janssen Research & Development; honorarium to serve as Section Editor of the Psychiatry & Behavioral Health Learning Network and as Guest Editor for Psychiatric Clinics of North America from Elsevier; consultant fees from Eleusis Therapeutics U.S., Inc, Janssen Global Services, Janssen Scientific Affairs, Boehringer Ingelheim, and Guidepoint Global; fees to serve on Data Safety and Monitoring Board for Worldwide Clinical Trials (Eliem and Inversargo), Vicore Pharma and IQVIA (Click); and honoraria for educational presentations from North American Center for Continuing Medical Education, Medscape/WebMD, Clinical Care Options, H.C. Wainwright & Co., and Global Medical Education. Dr. Madhukar H. Trivedi has provided consulting services to Acadia Pharmaceuticals, Alkermes Inc., Alto Neuroscience Inc, Axsome Therapeutics, BasePoint Health management LLC, Biogen MA Inc, Cerebral Inc., Circular Genomics Inc., Compass Pathfinder Limited, Daiichi Sankyo Inc., GH Research, GreenLight VitalSign6 Inc, Heading Health, Janssen Pharmaceutical, Legion Health, Merck Sharp & Dohme Corp., Mind Medicine Inc., Myriad Neuroscience, Naki Health Ltd, Neurocrine Biosciences Inc., Noema Pharma AG, Orexo US Inc., Otsuka America Pharmaceutical Inc., Otsuka Europe LTD, Otsuka Pharmaceutical Development & Commercialization Inc., Praxis Precision Medicines Inc, PureTech LYT Inc, Relmada Therapeutics Inc., SAGE Therapeutics, Signant Health, Sparian Biosciences, Titan Pharmaceuticals, Takeda Pharmaceuticals Inc, WebMD. He has received grant/research funding from NIMH, NIDA, NCATS, American Foundation for Suicide Prevention, Patient-Centered Outcomes Research Institute (PCORI), Blue Cross Blue Shield of Texas, SAMHSA, and the DoD. Additionally, he has received editorial compensation from Elsevier and Oxford University Press.

: This study is sponsored by the Center for Clinical Trials Network (CCTN), which manages NIDA’s National Drug Abuse Treatment Clinical Trials Network (CTN). NIDA/CCTN plays a substantial role in the Data and Safety Monitoring Board (DSMB), protocol development, data analysis and subsequent data sharing responsibilities. Publications of CTN studies are reviewed by CTN Publications Committee and are not determined by the sponsor.