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

Overview

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.

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 hygien
• 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. M
• 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 as
• 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
• 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 antih
• 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.

Primary outcome measures

• Biochemical validated tobacco abstinence at 26-week follow-up [Time frame: 26-week follow-up]

Secondary outcome measures (8)

• Biochemical validated tobacco abstinence at 8-week follow-up [Time frame: 8-week follow-up]
• Self-reported 7-day point prevalence abstinence at 8-week follow-up [Time frame: 8-week follow-up]
• Self-reported 7-day point prevalence abstinence at 26-week follow-up [Time frame: 26-week follow-up]
• Incidence rate of side effects/adverse events [Time frame: 8-week follow-up]
• Number of cigarettes smoked per day at the 8-week follow-up [Time frame: 8 weeks]
• Number of cigarettes smoked per day at the 26-week follow-up [Time frame: 26-week follow-up]
• Withdrawal symptoms [Time frame: 8 weeks]
• Questionnaire of Smoking Urges-Brief (QSU-B) [Time frame: 8 weeks]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Hong Kong · 1 center

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

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. PMID 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. PMID 3933739

Identifiers

NCT: NCT06931054 · Acupuncture_protocol_v3 · 23B2/056A_R1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗