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Completed

NCT Number: NCT02768025

Trial of Treatment Protocol for Smoking Cessation

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dunsan Korean Medicine Hospital of Daejeon University

Daejeon, 35235, South Korea

About this study

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.)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Traditional & Complementary Medicine treatment

Other

Body acupuncture, Ear acupuncture and aromatic therapy

NRT, counselling

Other

Nicotine Replacement Therapy, counselling

Primary outcomes

  1. Continuous Abstinence Rate

    Time frame: 4 week

    endpoint of treatment

Secondary outcomes

  1. 7-day Point Prevalence Abstinence

    Time frame: 6,8,12,16,24 week

    follow-up measure

  2. Prolonged Abstinence Rate

    Time frame: 3,6 month

    follow-up measure

  3. Program participation rate

    Time frame: 0,7,10,14,17 day, 3,4,6,8,12,16,24 week

    each treatment and follow-up

  4. Amount of smoking

    Time frame: 0,7,10,14,17 day, 3,4,6,8,12,16,24 week

    each treatment and follow-up

  5. Tobacco craving

    Time frame: 0,7,10,14,17 day, 3,4,6,8,12,16,24 week

    each treatment and follow-up

  6. Exhaled Carbon monoxide monoxide

    Time frame: 0,7,10,14,17 day, 3,4,6,8,12,16,24 week

    each treatment and follow-up

  7. Quality of life

    Time frame: 0,4 week

    beginning and endpoint of treatment

  8. Nicotine dependence test (Fagerstrom test)

    Time frame: 10, 17 day, 4week

  9. Withdrawal symptoms

    Time frame: 1,2,3,4 week

Sponsors and collaborators

Lead sponsor

Daejeon University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 11, 2016
Registry last updated
Feb 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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