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

NARecruitingINTERVENTIONAL
Enrollment

270

Participants

Timeline

Start Date

May 5, 2025

Primary Completion Date

October 30, 2026

Study Completion Date

October 30, 2026

Conditions
Smoking
Interventions
OTHER

Acupuncture

"The principle of traditional acupuncture and auricular acupressure is to alleviate withdrawal symptoms. Acupuncture therapy for smoking cessation is generally considered safe, but some people may experience mild side effects. These can include soreness, bruising, or bleeding at the needle insertion sites, dizziness, fatigue, or lightheadedness after treatment. Occasionally, individuals may feel nausea or discomfort during or after the session. In rare cases, infections can occur if proper hygiene protocols are not followed. Overall, most side effects are temporary and resolve shortly after treatment.~Primary Acupoints The selection of body acupuncture points follows specific guidelines\[11-12\], including three head points (Baihui, Shenting, Yintang ), three hand points (Neiguan, Kongzui, Lieque), and three foot points (Zusanli, Sanyinjiao, Taichong). For auricular acupoints, selection is based on corresponding areas (Mouth), syndrome differentiation of zang-fu organs and meridians (Hea"

DRUG

Nicotine Replacement therapy

Each eligible participant will be prescribed a two-week supply of NRT by a registered smoking cessation nurse following the initial counseling session. The nurse will determine the appropriate type and dosage of NRT based on the participant's level of nicotine dependence and lifestyle habits, and provide instructions on how to use the medication. NRT can cause some potential side effects such as nausea, headaches, dizziness, and insomnia, with vivid dreams being common for those using patches. Method-specific side effects include skin irritation from patches, mouth or throat irritation from gums or lozenges, and nasal or throat discomfort from inhalers and sprays. These symptoms usually lessen as the body adjusts, but persistent or worsening side effects may require medical attention. According to current smoking cessation medication guidelines from the Department of Health\[10\], participants who smoke 20 or more cigarettes per day will be prescribed 4 mg nicotine gum (or lozenges) or 2

BEHAVIORAL

Smoking cessation counseling

The first step for smoking cessation nurses is to assess each participant's smoking behavior using a baseline questionnaire. In the second step, informed consent will be obtained from the participants. The third step involves smoking cessation counseling using the 5A (Ask, Advise, Assess, Assist, Arrange) and 5R (Relevance, Risks, Rewards, Roadblocks, Repetition) frameworks as outlined in the smoking cessation manual published by the Department of Health. During this step, the nurse will also assess the type and dosage of NRT suitable for the participant. In the fourth step, participants will be introduced to TCM therapies, and arrangements will be made for consultations with a TCM practitioner.

OTHER

Auricular acupressure

First, one ear will be routinely disinfected with 75% medical ethanol. In the experimental group, the auricular acupressure tape contains Semen Vaccariae. Using forceps or tweezers, an auricular acupressure tape will be applied to specific acupoints on one ear for participants in the experimental group, followed by pressing the tape for 1 minute. The auricular tape will remain in place for two days, and participants will be instructed to self-press the acupoints 3 to 5 times daily, for 1 minute per acupoint each time. During the use of the auricular acupressure, if withdrawal symptoms occur, participants can immediately press the acupoints. The pressure applied should be tolerable, and the pressing duration should last until the withdrawal symptoms subside. Participants will also record the number of presses each day.

OTHER

Sham acupressure

"The sham tape resembles the genuine auricular acupressure tape with Semen Vaccariae but is a regular adhesive tape designed to minimize stimulation of the acupoints.~The sham auricular tape will be applied to non-smoking cessation acupoints, including:~* Elbow Acupoint located in the third section of the triangular fossa between the middle cartilage and the rim cartilage of the ear, primarily used for treating elbow pain.~* Ankle Acupoint located near the apex of the superior crus of the antihelix, used for treating arthritis.~* Urethra Acupoint located on the helix above the rectum acupoint, used for treating symptoms such as frequent urination or painful urination."

OTHER

Sham acupuncture

"The TCM practitioner will perform needle insertion 2-3 mm beside the selected acupoints (at non-specific sham points) using normal needling techniques but without manipulating the needles, in order to minimize any physiological effects."

Trial Locations (1)

Unknown

RECRUITING

School of Nursing, The University of Hong Kong, Hong Kong

All Listed Sponsors
lead

The University of Hong Kong

OTHER

NCT06931054 - Combination of Acupuncture, Auricular Acupressure and Nicotine Replacement Therapy for Smoking Cessation | Biotech Hunter | Biotech Hunter