Effect of Self-administered Auricular Acupressure on Smoking Cessation-a Pilot Study

Study Overview
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Brief Summary
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Auricular acupressure has been practiced in China and Germany to help people in smoking cessation programs. The purpose of this clinical trial is to test for the clinical effectiveness of self-administered auricular acupressure as a non-invasive method for smoking cessation.

Detailed Description
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Auricular acupressure has been practiced in China and Germany to help people in smoking cessation programs with varying degrees of success in different settings. The purpose of this clinical trial is to test for the clinical effectiveness of self-administered auricular acupressure as a non-invasive method for smoking cessation.

Official Title
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Effect of Self-administered Auricular Acupressure on Smoking Cessation-a Pilot Study

Conditions
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Smoking Cessation

Intervention / Treatment
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* Other: acupuncture
* Other: acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants are included in the study if they satisfy the following criteria: Male or female. Between 18 and 75 years of age inclusive. Able to provide informed consent to study. History of tobacco cigarette smoking for at least 6 months. Confirmed intention of smoking cessation with no more than 2 previous failed attempts in the last 3 year. Exclusion Criteria: Existing pharmacotherapy for smoking cessation. History of major psychiatric disorder or chronic pain syndromes. More than 2 failed attempts of smoking cessation in the previous 3 years. History of other substance abuse. History of atopy, or suspected/known allergy to plaster.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: NADA points and digital pressure<br>Arm 1: NADA points and digital pressure with urge. | Other: acupuncture<br>* National Acupuncture Detoxification Association (NADA) points + digital pressure<br>|
| Experimental: Arm 2: random points + digital pressure with urge<br>Arm 2 (20 participants): random points + digital pressure with urge | Other: acupuncture<br>* random points + digital pressure<br>|
| No Intervention: Arm 3 (20 participants): NO acupressure, only advice + support<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spot 7-day cessation rate | Efficacy of intervention for smoking cessation | Weekly during the intervention period (weeks 1-6) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuous Cessation Rate (CAR) | Efficacy of intervention for smoking cessation | Weekly during the intervention period (weeks 1-6) and week 13 and week 26 | 
| End-expiratory carbon monoxide levels (CO) | Efficacy of intervention for smoking cessation | Weekly during the intervention period (weeks 1-6) and week 13 and week 26 | 
| Adverse effects in terms of self-reported discomfort levels from auricular acupressure | Nature and incidence of adverse events due to intervention | Weekly during the intervention period (weeks 1-6) | 
| Stress level according to the Stress Check List (SCL) | Nature and incidence of adverse events due to intervention | Weekly during the intervention period (weeks 1-6) and week 13 and week 26 | 
| Nicotine withdrawal symptoms according to Minnesota Nicotine Withdrawal Scale (MNWS) | Nature and incidence of adverse events due to intervention | Weekly during the intervention period (weeks 1-6) and week 13 and week 26 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, smoking cessation