Trial of Treatment Protocol for Smoking Cessation

Study Overview
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Brief Summary
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Background: As smoking regulatory policies, including the WHO FCTC (Framework Convention on Tobacco Control), are enforcing, demand for smoking cessation treatment is being increased. According the trend, development and evaluation of the medical guideline, Induced participation of medical personnel and available in Korean medical clinic, is needed. Purpose: To evaluate the satisfaction and effect of traditional & complementary medicine (T&CM) tobacco control program Methods: Recruited subjects were divided into control and test groups. They treated two times a week during the first three weeks and once a week during the last week. Program participation rates and drop rates, satisfaction, amount of smoking before and after programs , smoking-related key variables, nicotine dependence test (Fagerstrom test), Expired CO amounts, urinary cotinine amount, withdrawal symptoms, the change in quality of life(EQ-5D) are measured.

Detailed Description
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Subjects in control group are treated NRT and counselling. Nicotine Replacement Therapy is provided 7 patches and 30 gums once a week for 4 weeks. Using amounts are depend on each subject's cravings. (Investigator will check how much they used.) Doctor consults about 10-15 minutes per visit. Subjects in intervention group are treated NRT, counselling and traditional & complementary medicine treatment (Body acupuncture, Ear acupuncture and aromatic therapy). Body acupoints are HT7, LI4, ST36, LU7, LU6 on both sides. Ear acupoints are Shenmen, Lung, Pharynx, Trachea, Endocrine. Subjects are treated with acupuncture for 20 minutes per visit and put ear acupuncture like sticker for 1-2 days. Mixture oil of Lavender, peppermint, rosemary are used to massage behind the ears. It is used 2 times a day and they can adjust frequency depending on their cravings.(Investigator will check how much they used.)

Official Title
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Trial of Treatment Protocol for Smoking Cessation: A Pragmatic Randomized Controlled Pilot Study

Conditions
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Smoking Cessation

Intervention / Treatment
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* Other: Traditional & Complementary Medicine treatment
* Other: NRT, counselling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) having willing to stop smoking 2) currently smoking and applying one of the following Exclusion Criteria: 1) suffering in the last 2 weeks cardiovascular disease or Severe arrhythmias, unstable angina 2) suffering from severe arrhythmia

Ages Eligible for Study
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Minimum Age: 19 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>NRT, counselling, traditional & complementary medicine treatment (Body acupuncture, Ear acupuncture and aromatic therapy). | Other: Traditional & Complementary Medicine treatment<br>* Body acupuncture, Ear acupuncture and aromatic therapy<br>Other: NRT, counselling<br>* Nicotine Replacement Therapy, counselling<br>|
| Active Comparator: Control group<br>NRT, counselling | Other: NRT, counselling<br>* Nicotine Replacement Therapy, counselling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuous Abstinence Rate | endpoint of treatment | 4 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day Point Prevalence Abstinence | follow-up measure | 6,8,12,16,24 week | 
| Prolonged Abstinence Rate | follow-up measure | 3,6 month | 
| Program participation rate | each treatment and follow-up | 0,7,10,14,17 day, 3,4,6,8,12,16,24 week | 
| Amount of smoking | each treatment and follow-up | 0,7,10,14,17 day, 3,4,6,8,12,16,24 week | 
| Tobacco craving | each treatment and follow-up | 0,7,10,14,17 day, 3,4,6,8,12,16,24 week | 
| Exhaled Carbon monoxide monoxide | each treatment and follow-up | 0,7,10,14,17 day, 3,4,6,8,12,16,24 week | 
| Quality of life | beginning and endpoint of treatment | 0,4 week | 
| Nicotine dependence test (Fagerstrom test) |  | 10, 17 day, 4week | 
| Withdrawal symptoms |  | 1,2,3,4 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking cessation, tobacco control, acupuncture, Korean Medicine, Traditional & Complementary Medicine