Abstract
BACKGROUND: Tobacco dependence poses significant health and economic burdens globally, with over one billion smokers and eight million deaths annually. Current smoking cessation strategies, including pharmacotherapy and behavioral treatments, often have limited efficacy and potential side effects. Acupuncture, a potential alternative treatment, has shown promise in previous studies, but its mechanism and long-term effects on craving remain unclear. METHODS/DESIGN: This two-center, randomized, controlled clinical trial will enroll 192 patients with moderate to severe tobacco dependence and randomly assign them to Acupuncture, sham-Acupuncture, or basic smoking cessation intervention groups in a 1:1:1 ratio. Blinding will be performed on participants in the Acupuncture, sham-Acupuncture groups and statistical analysts. The 12-week trial will involve 8 weeks of treatment and 4 weeks of follow-up. The primary outcome is abstinence rate at week 8. Secondary outcomes include assessment with the following instruments: craving levels via the Visual Analog Scale and Tobacco Craving Questionnaire, withdrawal symptoms via the Minnesota Withdrawal Scale, working memory via the Sternberg paradigm, and response inhibition ability via the Go/NoGo task. Adverse events will be recorded. The study will adhere to SPIRIT guidelines. DISCUSSION: This trial will investigate the efficacy of acupuncture for tobacco dependence by including a sham control and examining long-term craving effects. Findings will contribute to understanding the potential of acupuncture as a safe and effective treatment option for tobacco dependence. TRIAL REGISTRATION: This trial was registered on the International Traditional Medicine Clinical Trial Registry (Registration number: ITMCTR2024000817) on November 18, 2024.