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Yet, there are no U.S. Food and Drug Administration (FDA) approved treatments available. The STIMULUS study is a multi-site trial, sponsored by the National Drug Abuse Treatment Clinical Trials Network (CTN), that aims to investigate the feasibility and preliminary efficacy of repetitive transcranial magnetic stimulation (rTMS) as a potential treatment for moderate to severe CcUD\/MtUD.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods<\/jats:title>\n            <jats:p>The study is a double-blind, sham-controlled trial seeking to recruit 160 participants with a current moderate to severe CcUD or MtUD diagnosis, randomized to receive active rTMS (10-Hz stimulation at 120% motor threshold over the left dorsolateral prefrontal cortex) or sham. Feasibility is assessed by a target of at least 20 treatment sessions administered within an 8-week period. Additionally, the study aims to evaluate the efficacy of rTMS in reducing stimulant use and craving, the impact of rTMS on mood, anxiety, sleep, and other measures, and the utility of electroencephalography as a treatment response biomarker.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Discussion<\/jats:title>\n            <jats:p>Studies exploring rTMS for stimulant use disorders remain limited by small sample sizes, as well as great heterogeneity in defined study population, treatment parameters, retention in treatment, and number of sessions. In this paper, we highlight key study design decisions, such as safety, sham procedure, and schedule flexibility.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusion<\/jats:title>\n            <jats:p>We hope that the data collected will lay the groundwork for a robust randomized controlled trial of rTMS as a therapeutic intervention for individuals with CcUD\/MtUD.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Trial registration<\/jats:title>\n            <jats:p>\n              <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/www.ClinicalTrials.gov\" ext-link-type=\"uri\">http:\/\/www.ClinicalTrials.gov<\/jats:ext-link>. Identifier: NCT04907357.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Trial data set<\/jats:title>\n            <jats:p>\n              <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/clinicaltrials.gov\/study\/NCT04907357?tab=table\" ext-link-type=\"uri\">https:\/\/clinicaltrials.gov\/study\/NCT04907357?tab=table<\/jats:ext-link>.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Protocol<\/jats:title>\n            <jats:p>Version 7.0, 11\/10\/2023.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1186\/s13722-025-00567-w","type":"journal-article","created":{"date-parts":[[2025,5,8]],"date-time":"2025-05-08T02:40:04Z","timestamp":1746672004000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Repetitive transcranial magnetic stimulation for stimulant use disorders (STIMULUS): protocol for a multi-site, double-blind, randomized controlled trial"],"prefix":"10.1186","volume":"20","author":[{"given":"Zahraa","family":"Atoui","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Donald","family":"Egan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manish Kumar","family":"Jha","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karen","family":"Hartwell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Russell","family":"Toll","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan","family":"Sonne","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brenda","family":"Brunner-Jackson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Geetha","family":"Subramaniam","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jenna L.","family":"McCauley","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Madhukar","family":"Trivedi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathleen","family":"Brady","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,5,8]]},"reference":[{"key":"567_CR1","unstructured":"Substance Abuse and Mental Health Services Administration. 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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.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"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.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}},{"value":"This study is sponsored by the Center for Clinical Trials Network (CCTN), which manages NIDA\u2019s 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.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Trial sponsor"}}],"article-number":"40"}}