Combination of Acupuncture, Auricular Acupressure and Nicotine Replacement Therapy for Smoking Cessation

Not Applicable

Recruiting

• Conditions: Smoking
• Interventions: Other: Acupuncture; Drug: Nicotine Replacement therapy; Other: Sham acupressure; Behavioral: Smoking cessation counseling; Other: Auricular acupressure; Other: Sham acupuncture

• Registration Number: NCT06931054
• Lead Sponsor: The University of Hong Kong

Brief Summary

The aims of this study include: (1) to evaluate whether a combined smoking cessation treatment of acupuncture, auricular acupressure, and nicotine replacement therapy (NRT) is more effective in improving smoking cessation rates at a 6-month follow-up compared to NRT alone; (2) to assess whether the combined smoking cessation treatment of acupuncture, auricular acupressure, and NRT increases the incidence of side effects compared to NRT alone; (3) to evaluate whether the combined smoking cessation treatment of acupuncture, auricular acupressure, and NRT is more effective in reducing withdrawal symptoms compared to NRT alone. This study will randomly assign participants into three groups. The total sample size is set at 270 participants, with each group consisting of 90 participants. The randomization ratio is 1:1:1.

Detailed Description

The aims of this study include: (1) to evaluate whether a combined smoking cessation treatment of acupuncture, auricular acupressure, and nicotine replacement therapy (NRT) is more effective in improving smoking cessation rates at a 6-month follow-up compared to NRT alone; (2) to assess whether the combined smoking cessation treatment of acupuncture, auricular acupressure, and NRT increases the incidence of side effects compared to NRT alone; (3) to evaluate whether the combined smoking cessation treatment of acupuncture, auricular acupressure, and NRT is more effective in reducing withdrawal symptoms compared to NRT alone. This study will randomly assign participants into three groups. The total sample size is set at 270 participants, with each group consisting of 90 participants. The randomization ratio is 1:1:1.

The intervention group will receive a combination of acupuncture, auricular acupressure, and NRT as a smoking cessation treatment. Control Group 1 will receive a sham version of the combined treatment (i.e., retractable needles that do not penetrate the skin and placebo auricular acupressure). Neither the participants in the experimental group nor those in Control Group 1 will know their group assignment, ensuring a double-blind, 3-arm RCT. Control Group 2 will receive NRT and undergo a standard Chinese medicine general consultation (including observation, auscultation and olfaction, inquiry, pulse-taking, and general health advice) during the initial visit, but will not receive acupuncture or auricular acupressure. Participants in the experimental group and Control Group 1 will not be aware of their specific group assignment. The study protocol will follow the CONSORT guidelines and will seek approval from the university's research ethics committee. Smoking cessation nurses or counsellors will deliver the counseling, The 8-week and 26-week follow up outcome assessments will be done by research assistants and should be blinded of group allocation. Self-reported quitters at 26-week follow-up will be invited for a biochemical validation.

Study Timeline

• Study First Submitted: 2025-04-14
• Study First Submitted QC: 2025-04-14
• Study First Posted: 2025-04-16
• Status Verified: 2025-05
• Study Start: 2025-05-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-11
• Primary Completion: 2026-10-30
• Study Completion: 2026-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

1. Individuals aged 18 or older.
2. Individuals who consume at least 10 traditional cigarettes per day.
3. Individuals with access to a smartphone for communication and internet use.
4. Individuals who are able to read and write Chinese.

Exclusion Criteria

1. Previous use of acupuncture for smoking cessation or any other condition.
2. Skin problems related to diabetes.
3. Hyperthyroidism.
4. Hospitalized at Intensive Care Unit in the past 4 weeks.
5. Severe cardiovascular diseases.
6. Pregnancy.
7. Breastfeeding.
8. History of severe adverse reactions to acupuncture.
9. Current use of blood-thinning medication or having a bleeding disorder.
10. Current use of other smoking cessation services.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Acupuncture	Acupuncture, auricular acupressure, nicotine replacement therapy and smoking cessation counseling
Experimental group	Nicotine Replacement therapy	Acupuncture, auricular acupressure, nicotine replacement therapy and smoking cessation counseling
Control group 1	Sham acupressure	Sham acupuncture, sham acupressure, nicotine replacement therapy and smoking cessation counseling
Experimental group	Smoking cessation counseling	Acupuncture, auricular acupressure, nicotine replacement therapy and smoking cessation counseling
Experimental group	Auricular acupressure	Acupuncture, auricular acupressure, nicotine replacement therapy and smoking cessation counseling
Control group 1	Nicotine Replacement therapy	Sham acupuncture, sham acupressure, nicotine replacement therapy and smoking cessation counseling
Control group 1	Smoking cessation counseling	Sham acupuncture, sham acupressure, nicotine replacement therapy and smoking cessation counseling
Control group 1	Sham acupuncture	Sham acupuncture, sham acupressure, nicotine replacement therapy and smoking cessation counseling
Control group 2	Nicotine Replacement therapy	Nicotine replacement therapy, smoking cessation counseling
Control group 2	Smoking cessation counseling	Nicotine replacement therapy, smoking cessation counseling

Primary Outcome Measures

Name	Time	Method
Biochemical validated tobacco abstinence at 26-week follow-up	26-week follow-up	Biochemically verified quitting is defined as a carbon monoxide (CO) level in exhaled breath measured by a CO monitor of less than or equal to 3 ppm, and a salivary cotinine level of less than or equal to 30 ng/ml, as tested by a cotinine test strip.

Secondary Outcome Measures

Name	Time	Method
Biochemical validated tobacco abstinence at 8-week follow-up	8-week follow-up	Biochemically verified quitting is defined as a carbon monoxide (CO) level in exhaled breath measured by a CO monitor of less than or equal to 3 ppm
Self-reported 7-day point prevalence abstinence at 8-week follow-up	8-week follow-up	Self-reported 7-day point prevalence abstinence
Self-reported 7-day point prevalence abstinence at 26-week follow-up	26-week follow-up	Self-reported 7-day point prevalence abstinence
Incidence rate of side effects/adverse events	8-week follow-up	Incidence rate of side effects/adverse events (e.g., needle fainting, bleeding, etc.).
Number of cigarettes smoked per day at the 8-week follow-up	8 weeks	Number of cigarettes smoked per day (in smokers)
Number of cigarettes smoked per day at the 26-week follow-up	26-week follow-up	Number of cigarettes smoked per day (in smokers)
Withdrawal symptoms	8 weeks	Minnesota Nicotine Withdrawal Scale (MNWS), measured through ecological momentary assessment, scale range from 7 to 35, higher scores mean more frequent withdrawal symptoms
Questionnaire of Smoking Urges-Brief (QSU-B)	8 weeks	The 10-item Questionnaire of Smoking Urges-Brief (QSU-B) is used to measure the desire and anticipation of smoking

Trial Locations

Locations (1)

School of Nursing, The University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong