Smoking Cessation Clinical Trial
Official title:
Effect of Self-administered Auricular Acupressure on Smoking Cessation—a Pilot Study
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | January 2016 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Canada | Queen's Family Health Team | Kingston | Ontario |
Lead Sponsor | Collaborator |
---|---|
Queen's University |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Spot 7-day cessation rate | Efficacy of intervention for smoking cessation | Weekly during the intervention period (weeks 1-6) | No |
Secondary | Continuous Cessation Rate (CAR) | Efficacy of intervention for smoking cessation | Weekly during the intervention period (weeks 1-6) and week 13 and week 26 | No |
Secondary | 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 | No |
Secondary | 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) | Yes |
Secondary | 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 | Yes |
Secondary | 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 | Yes |
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