Atoui Zahraa, Egan Donald, Jha Manish Kumar, Hartwell Karen, Toll Russell, Sonne Susan, Brunner-Jackson Brenda, Subramaniam Geetha, McCauley Jenna L, Trivedi Madhukar, Brady Kathleen
Medical University of South Carolina, Charleston, SC, 29425, USA.
UT Southwestern Medical Center, Dallas, TX, USA.
Addict Sci Clin Pract. 2025 May 8;20(1):40. doi: 10.1186/s13722-025-00567-w.
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.
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.
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.
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.
gov . Identifier: NCT04907357. TRIAL DATA SET: https://clinicaltrials.gov/study/NCT04907357?tab=table .
Version 7.0, 11/10/2023.
可卡因和甲基苯丙胺使用障碍（CcUD/MtUD）会带来严重的公共卫生、医学和精神后果。然而，美国食品药品监督管理局（FDA）尚未批准任何可用的治疗方法。刺激（STIMULUS）研究是一项由国家药物滥用治疗临床试验网络（CTN）赞助的多中心试验，旨在研究重复经颅磁刺激（rTMS）作为中度至重度CcUD/MtUD潜在治疗方法的可行性和初步疗效。
该研究是一项双盲、假刺激对照试验，旨在招募160名目前被诊断为中度至重度CcUD或MtUD的参与者，随机分为接受活性rTMS（在左侧背外侧前额叶皮质以运动阈值的120%进行10赫兹刺激）或假刺激组。通过在8周内至少进行20次治疗的目标来评估可行性。此外，该研究旨在评估rTMS在减少兴奋剂使用和渴望方面的疗效、rTMS对情绪、焦虑、睡眠和其他指标的影响，以及脑电图作为治疗反应生物标志物的效用。
探索rTMS治疗兴奋剂使用障碍的研究仍然受到样本量小以及定义的研究人群、治疗参数、治疗保留率和疗程数量存在巨大异质性的限制。在本文中，我们强调了关键的研究设计决策，如安全性、假刺激程序和时间表灵活性。
我们希望收集到的数据将为一项强有力的随机对照试验奠定基础，该试验将rTMS作为CcUD/MtUD个体的治疗干预措施。
版本7.0，2023年11月10日。
