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SmokingacupunctureNCT06931054

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

A study testing Acupuncture, Nicotine Replacement therapy and Smoking cessation counseling in people with Smoking, run by The University of Hong Kong at 1 site in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Smoking
What is being tested?
Acupuncture, Nicotine Replacement therapy and Smoking cessation counseling
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
270 participants
Where
1 siteHong Kong
Study dates
5 May 2025to 30 Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Derek Cheung, PhD contact

+852 39176652

derekcheung@hku.hk

Hong Kong1 site, 1 recruiting
  • School of Nursing, The University of Hong Kong

    Hong Kong

    Derek Cheung, PhD, +852 39176652, derekcheung@hku.hk

    Recruiting

Other trials in Hong Kong

About this study

Official title: Combination of Acupuncture, Auricular Acupressure and Nicotine Replacement Therapy for Smoking Cessation: A Randomized Controlled Trial

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.

Read the 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.

Conditions
Smoking
Being tested
Acupuncture, Nicotine Replacement therapy, Smoking cessation counseling, Auricular acupressure, Sham acupressure
Keywords
Acupuncture, Smoking cesastion, NRT, Acupressure
Medical subject headings
Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AcupunctureOther

    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

  • Nicotine Replacement therapyDrug

    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

  • Smoking cessation counselingBehavioural

    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.

  • Auricular acupressureOther

    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.

  • Sham acupressureOther

    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.
  • Sham acupunctureOther

    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.

Study groups in NCT06931054
Study groupRoleWhat they receive
Experimental groupExperimentalAcupuncture, auricular acupressure, nicotine replacement therapy and smoking cessation counseling
Receives: Other: Acupuncture; Drug: Nicotine Replacement therapy; Behavioral: Smoking cessation counseling; Other: Auricular acupressure
Control group 1Sham comparatorSham acupuncture, sham acupressure, nicotine replacement therapy and smoking cessation counseling
Receives: Drug: Nicotine Replacement therapy; Behavioral: Smoking cessation counseling; Other: Sham acupressure; Other: Sham acupuncture
Control group 2Active comparatorNicotine replacement therapy, smoking cessation counseling
Receives: Drug: Nicotine Replacement therapy; Behavioral: Smoking cessation counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biochemical validated tobacco abstinence at 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.

    Measured: 26-week follow-up

Secondary outcomes (8)
  1. Biochemical validated tobacco abstinence at 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

    Measured: 8-week follow-up

  2. Self-reported 7-day point prevalence abstinence at 8-week follow-up

    Self-reported 7-day point prevalence abstinence

    Measured: 8-week follow-up

  3. Self-reported 7-day point prevalence abstinence at 26-week follow-up

    Self-reported 7-day point prevalence abstinence

    Measured: 26-week follow-up

  4. Incidence rate of side effects/adverse events

    Incidence rate of side effects/adverse events (e.g., needle fainting, bleeding, etc.).

    Measured: 8-week follow-up

  5. Number of cigarettes smoked per day at the 8-week follow-up

    Number of cigarettes smoked per day (in smokers)

    Measured: 8 weeks

  6. Number of cigarettes smoked per day at the 26-week follow-up

    Number of cigarettes smoked per day (in smokers)

    Measured: 26-week follow-up

  7. Withdrawal symptoms

    Minnesota Nicotine Withdrawal Scale (MNWS), measured through ecological momentary assessment, scale range from 7 to 35, higher scores mean more frequent withdrawal symptoms

    Measured: 8 weeks

  8. Questionnaire of Smoking Urges-Brief (QSU-B)

    The 10-item Questionnaire of Smoking Urges-Brief (QSU-B) is used to measure the desire and anticipation of smoking

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2025
  2. Study start5 May 2025
  3. Primary completion30 Oct 2026 (estimated)
  4. Study completion30 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
270 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06931054
Sponsor's protocol ID
Acupuncture_protocol_v3
Other IDs
23B2/056A_R1
Acronym
acupuncture
Status last verified
May 2025
First submitted
14 Apr 2025
Last updated
11 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The participant data can be made available upon requests with justification on legitimite research purposes.

Publications

  • Shiffman S. Conceptualizing analyses of ecological momentary assessment data. Nicotine Tob Res. 2014 May;16 Suppl 2(Suppl 2):S76-87. doi: 10.1093/ntr/ntt195. Epub 2013 Dec 9.

    PubMed 24323571
  • Clavel F, Benhamou S, Company-Huertas A, Flamant R. Helping people to stop smoking: randomised comparison of groups being treated with acupuncture and nicotine gum with control group. Br Med J (Clin Res Ed). 1985 Nov 30;291(6508):1538-9. doi: 10.1136/bmj.291.6508.1538. No abstract available.

    PubMed 3933739

Questions about this trial

What is this clinical trial studying?

A study testing Acupuncture, Nicotine Replacement therapy and Smoking cessation counseling in people with Smoking, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Derek Cheung, PhD (+852 39176652, derekcheung@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biochemical validated tobacco abstinence at 26-week follow-up (time frame: 26-week follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06931054, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.

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