Harmonizing mind acupuncture combined with nicotine replacement therapy for tobacco use disorder

A protocol for a pragmatic randomized controlled trial

Dados Bibliográficos

ID22433522
AutoresChuanxiong Li (0000-0002-7511-9933, Yunnan University), Binyang Wang (Kunming Medical University), B H Wang (0000-0003-4501-7685, Kunming Medical University), Song Zhao (0000-0002-7931-1877, Yunnan University), Qianwen Ruan (Kunming Medical University), Lei Pan (0000-0002-6044-0978, Second People's Hospital of Yunnan Province, autor correspondente), Meihua Qiu (0000-0001-6803-5582, Yunnan University, autor correspondente)
Ano2026
Volume14
Data de publicação2026-07-16
Peer ReviewedSim
Open AccessSim
TipoARTICLE
PeriódicoFrontiers in Public Health (JOURNAL)
Identificadores do periódicoISSN: 2296-2565 • E-ISSN: 2296-2565
EditoraFrontiers Media SA (PUBLISHER • CH)
DOI10.3389/fpubh.2026.1850199
OpenAlexW7169061007
IdiomaEN
Referências citadas40

Background 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). Methods 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. Discussion 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. Ethics approval and consent to participate 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. Clinical trial registration This trial has been registered with the International Traditional Medicine Clinical Trial Registry (ITMCTR) under registration number: ITMCTR2026000683 ( https://itmctr.ccebtcm.org.cn/ ).

Abstinence · Acupuncture · Anxiety · Clinical endpoint · Craving · Nicotine · Nicotine replacement therapy · Randomized controlled trial · Smoking cessation · Acupuncture Treatment Research Studies · Heme Oxygenase-1 and Carbon Monoxide · Smoking Behavior and Cessation