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

Last updated: May 6, 2025
Sponsor: The University of Hong Kong
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Smoking cessation counseling

Auricular acupressure

Acupuncture

Clinical Study ID

NCT06931054
Acupuncture_protocol_v3
23B2/056A_R1
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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

Total Participants: 270
Treatment Group(s): 6
Primary Treatment: Smoking cessation counseling
Phase:
Study Start date:
May 05, 2025
Estimated Completion Date:
October 30, 2026

Study 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.

Connect with a study center

  • School of Nursing, The University of Hong Kong

    Hong Kong,
    Hong Kong

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.