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

The University of Hong Kong (HKU)

Status: Begins enrollment this month

Conditions: Smoking

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06931054

Acupuncture_protocol_v3

23B2/056A_R1 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 270 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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270 participants in 3 patient groups

Experimental group

Experimental group

Description:

Acupuncture, auricular acupressure, nicotine replacement therapy and smoking cessation counseling

Treatment:

Behavioral: Smoking cessation counseling

Other: Acupuncture

Other: Auricular acupressure

Drug: Nicotine Replacement therapy

Control group 1

Sham Comparator group

Description:

Sham acupuncture, sham acupressure, nicotine replacement therapy and smoking cessation counseling

Treatment:

Other: Sham acupuncture

Behavioral: Smoking cessation counseling

Other: Sham acupressure

Drug: Nicotine Replacement therapy

Control group 2

Active Comparator group

Description:

Nicotine replacement therapy, smoking cessation counseling

Treatment:

Behavioral: Smoking cessation counseling

Drug: Nicotine Replacement therapy