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HMA plus NRT protocol aims to reduce nicotine craving and boost abstinence in TUDNew Trial to Test Acupuncture for Smoking Cessation

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Key Takeaway
Consider awaiting results of this HMA plus NRT trial before changing practice.

This is a protocol for a planned randomized controlled trial, not a study with results. The trial will enroll 220 participants with tobacco use disorder (TUD) at a single center under real-world clinical conditions. Participants will be randomized to receive either harmonizing mind acupuncture (HMA) combined with nicotine replacement therapy (NRT) or NRT alone. The primary outcomes are change in nicotine craving measured by a visual analog scale (VAS) from baseline to week 6, and 7-day point prevalence abstinence (PPA) biochemically verified by exhaled carbon monoxide at week 6. Secondary outcomes include exhaled carbon monoxide, quality of life, sleep quality, depressive symptoms, anxiety symptoms, and safety outcomes. Follow-up extends to 24 weeks. Safety data, including adverse events, serious adverse events, discontinuations, and tolerability, are not reported in this protocol. The main limitation is that this is a protocol for a planned trial; no results are available. The study aims to evaluate the effectiveness and safety of HMA as an adjunct to NRT under real-world conditions, but its clinical relevance will depend on the eventual results.

How this fits prior evidence

This protocol addresses a gap in prior evidence by proposing to test acupuncture as an adjunct to NRT, whereas prior coverage focused on assessment timing and pharmacotherapy. Specifically, earlier coverage suggested that 4-week assessment intervals may improve abstinence in lung cancer screening candidates, and that adding bupropion or varenicline to NRT was linked to lower mortality in post-ACS patients. This trial will provide prospective data on a non-pharmacological adjunct, potentially extending the range of options for tobacco cessation. However, as a protocol, it does not yet confirm or contrast with these findings.

Researchers have published a plan for a new clinical trial that will test whether adding a type of acupuncture to standard nicotine replacement therapy (NRT) can help people with tobacco use disorder quit smoking. The study, which has not yet started, will involve 220 participants and will be conducted in a real-world clinical setting.

The trial will compare two groups: one receiving harmonizing mind acupuncture (HMA) plus NRT, and the other receiving NRT alone. The main goals are to measure changes in nicotine craving using a visual analog scale and to check if participants have stopped smoking for at least seven days, verified by exhaled carbon monoxide levels, at the six-week mark.

The researchers will also track quality of life, sleep, mood, and safety outcomes over a 24-week follow-up period. However, because this is a protocol, no results are available yet. The study aims to see if adding acupuncture to standard treatment could offer extra benefits for people trying to quit smoking.

It is important to note that this is a plan for a future study, not a report of findings. The effectiveness and safety of this approach are not yet known. Readers should wait for the results before drawing any conclusions.

What this means for you:
A planned trial will test if adding acupuncture to nicotine replacement therapy helps with smoking cessation, but results are not yet available.

Common questions

What is this study about?

This is a plan for a clinical trial that will test whether adding a type of acupuncture called harmonizing mind acupuncture (HMA) to nicotine replacement therapy (NRT) helps people with tobacco use disorder quit smoking. The study will compare HMA plus NRT to NRT alone.

Who can participate in this trial?

The trial will include 220 participants who have tobacco use disorder. It will be conducted in a single-center, real-world clinical setting. Specific eligibility criteria are not detailed in the protocol.

What are the main outcomes being measured?

The main outcomes are changes in nicotine craving measured by a visual analog scale and 7-day point prevalence abstinence, which means not smoking for at least seven days, verified by exhaled carbon monoxide at week 6.

Are there any results from this study?

No, this is a protocol for a planned trial, so no results are available yet. The study has not been conducted. The effectiveness and safety of adding acupuncture to NRT are still unknown.

Study Details

Study typeRct
EvidenceLevel 2
PublishedJul 2026
View Original Abstract ↓
BackgroundTobacco 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).MethodsThis 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.DiscussionThis 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 participateEthical 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 registrationThis trial has been registered with the International Traditional Medicine Clinical Trial Registry (ITMCTR) under registration number: ITMCTR2026000683 (https://itmctr.ccebtcm.org.cn/).
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