Harmonizing mind acupuncture combined with nicotine replacement therapy for tobacco use disorder: a protocol for a...

Tobacco use disorder (TUD) remains a leading cause of preventable morbidity and mortality worldwide. Although nicotine replacement therapy (NRT) is recommended as a first-line treatment, its effectiveness is limited by persistent craving and withdrawal symptoms, resulting in high relapse rates. Acupuncture has been investigated as an adjunctive therapy; however, existing evidence is inconsistent and limited by methodological heterogeneity. High-quality pragmatic randomized controlled trials are needed. The co-primary outcomes are nicotine craving reduction (VAS) and biochemically verified 7-day point prevalence abstinence (PPA).

This is a single-center, pragmatic, randomized, parallel-group controlled trial. A total of 220 participants with TUD will be randomly assigned (1,1) to receive either harmonizing mind acupuncture (HMA) plus NRT or NRT alone. The intervention period will last 6 weeks, with follow-up to 24 weeks. The co-primary outcomes are: (1) the change in nicotine craving measured by a visual analog scale (VAS) from baseline to week 6; and (2) 7-day point prevalence abstinence (PPA) biochemically verified by exhaled carbon monoxide at week 6. Secondary outcomes include exhaled carbon monoxide (as a continuous measure), quality of life, sleep quality, depressive symptoms, anxiety symptoms, and safety outcomes. Analyses will be conducted according to the intention-to-treat principle.

This pragmatic randomized controlled trial will evaluate the effectiveness and safety of HMA as an adjunct to NRT under real-world clinical conditions and provide clinically relevant evidence to inform integrative treatment strategies for TUD.

Ethical approval has been obtained from the Ethics Committee of the Affiliated Hospital of Yunnan University (Approval No.: KJR#20251111-R1-055). The study will be conducted in accordance with the Declaration of Helsinki. Written informed consent will be obtained from all participants prior to enrollment.

This trial has been registered with the International Traditional Medicine Clinical Trial Registry (ITMCTR) under registration number: ITMCTR2026000683 (https://itmctr.ccebtcm.org.cn/).