Clinical trial NCT06931054: Combination of Acupuncture, Auricular Acupressure and Nicotine Replacement Therapy for Smoking Cessation
Official title: Combination of Acupuncture, Auricular Acupressure and Nicotine Replacement Therapy for Smoking Cessation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking
Keywords: Acupuncture
Smoking cesastion
NRT
Acupressure
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2025-04-16
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Biochemical validated tobacco abstinence at 26-week follow-up
timeFrame: 26-week follow-up
Secondary outcomes:
measure: Biochemical validated tobacco abstinence at 8-week follow-up
timeFrame: 8-week follow-up
measure: Self-reported 7-day point prevalence abstinence at 8-week follow-up
timeFrame: 8-week follow-up
measure: Self-reported 7-day point prevalence abstinence at 26-week follow-up
timeFrame: 26-week follow-up
measure: Incidence rate of side effects/adverse events
timeFrame: 8-week follow-up
measure: Number of cigarettes smoked per day at the 8-week follow-up
timeFrame: 8 weeks
measure: Number of cigarettes smoked per day at the 26-week follow-up
timeFrame: 26-week follow-up
measure: Withdrawal symptoms
timeFrame: 8 weeks
measure: Questionnaire of Smoking Urges-Brief (QSU-B)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Nursing, The University of Hong Kong
Study officials:
References:
citation: 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.
citation: 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.