Zahraa Atoui, Donald Egan, Manish Kumar Jha, Karen Hartwell, Russell Toll, Susan Sonne, Brenda Brunner-Jackson, Geetha Subramaniam, Jenna L McCauley, Madhukar Trivedi, Kathleen Brady
{"title":"重复经颅磁刺激治疗兴奋剂使用障碍（刺激物）：一项多地点、双盲、随机对照试验方案。","authors":"Zahraa Atoui, Donald Egan, Manish Kumar Jha, Karen Hartwell, Russell Toll, Susan Sonne, Brenda Brunner-Jackson, Geetha Subramaniam, Jenna L McCauley, Madhukar Trivedi, Kathleen Brady","doi":"10.1186/s13722-025-00567-w","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Cocaine and methamphetamine use disorders (CcUD/MtUD) have serious public health, medical, and psychiatric consequences. 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.</p><p><strong>Methods: </strong>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.</p><p><strong>Discussion: </strong>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.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Trial registration: </strong>http://www.</p><p><strong>Clinicaltrials: </strong>gov . Identifier: NCT04907357. TRIAL DATA SET: https://clinicaltrials.gov/study/NCT04907357?tab=table .</p><p><strong>Protocol: </strong>Version 7.0, 11/10/2023.</p>","PeriodicalId":54223,"journal":{"name":"Addiction Science & Clinical Practice","volume":"20 1","pages":"40"},"PeriodicalIF":3.7000,"publicationDate":"2025-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12060337/pdf/","citationCount":"0","resultStr":"{\"title\":\"Repetitive transcranial magnetic stimulation for stimulant use disorders (STIMULUS): protocol for a multi-site, double-blind, randomized controlled trial.\",\"authors\":\"Zahraa Atoui, Donald Egan, Manish Kumar Jha, Karen Hartwell, Russell Toll, Susan Sonne, Brenda Brunner-Jackson, Geetha Subramaniam, Jenna L McCauley, Madhukar Trivedi, Kathleen Brady\",\"doi\":\"10.1186/s13722-025-00567-w\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Cocaine and methamphetamine use disorders (CcUD/MtUD) have serious public health, medical, and psychiatric consequences. 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.</p><p><strong>Methods: </strong>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. 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Repetitive transcranial magnetic stimulation for stimulant use disorders (STIMULUS): protocol for a multi-site, double-blind, randomized controlled trial.
Background: Cocaine and methamphetamine use disorders (CcUD/MtUD) have serious public health, medical, and psychiatric consequences. 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.
Methods: 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.
Discussion: 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.
Conclusion: 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.
Trial registration: http://www.
Clinicaltrials: gov . Identifier: NCT04907357. TRIAL DATA SET: https://clinicaltrials.gov/study/NCT04907357?tab=table .
期刊介绍：
Addiction Science & Clinical Practice provides a forum for clinically relevant research and perspectives that contribute to improving the quality of care for people with unhealthy alcohol, tobacco, or other drug use and addictive behaviours across a spectrum of clinical settings.
Addiction Science & Clinical Practice accepts articles of clinical relevance related to the prevention and treatment of unhealthy alcohol, tobacco, and other drug use across the spectrum of clinical settings. Topics of interest address issues related to the following: the spectrum of unhealthy use of alcohol, tobacco, and other drugs among the range of affected persons (e.g., not limited by age, race/ethnicity, gender, or sexual orientation); the array of clinical prevention and treatment practices (from health messages, to identification and early intervention, to more extensive interventions including counseling and pharmacotherapy and other management strategies); and identification and management of medical, psychiatric, social, and other health consequences of substance use.
Addiction Science & Clinical Practice is particularly interested in articles that address how to improve the quality of care for people with unhealthy substance use and related conditions as described in the (US) Institute of Medicine report, Improving the Quality of Healthcare for Mental Health and Substance Use Conditions (Washington, DC: National Academies Press, 2006). Such articles address the quality of care and of health services. Although the journal also welcomes submissions that address these conditions in addiction speciality-treatment settings, the journal is particularly interested in including articles that address unhealthy use outside these settings, including experience with novel models of care and outcomes, and outcomes of research-practice collaborations.
Although Addiction Science & Clinical Practice is generally not an outlet for basic science research, we will accept basic science research manuscripts that have clearly described potential clinical relevance and are accessible to audiences outside a narrow laboratory research field.
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