Clinical trial NCT02768025: Trial of Treatment Protocol for Smoking Cessation
Official title: Trial of Treatment Protocol for Smoking Cessation: A Pragmatic Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: smoking cessation
tobacco control
acupuncture
Korean Medicine
Traditional & Complementary Medicine
Lead sponsor: Daejeon University
Sponsor class: OTHER
First posted: 2016-05-11
Enrollment: 41
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.)

Eligibility criteria: 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

Primary outcomes:
measure: Continuous Abstinence Rate
timeFrame: 4 week
Secondary outcomes:
measure: 7-day Point Prevalence Abstinence
timeFrame: 6,8,12,16,24 week
measure: Prolonged Abstinence Rate
timeFrame: 3,6 month
measure: Program participation rate
timeFrame: 0,7,10,14,17 day, 3,4,6,8,12,16,24 week
measure: Amount of smoking
timeFrame: 0,7,10,14,17 day, 3,4,6,8,12,16,24 week
measure: Tobacco craving
timeFrame: 0,7,10,14,17 day, 3,4,6,8,12,16,24 week
measure: Exhaled Carbon monoxide monoxide
timeFrame: 0,7,10,14,17 day, 3,4,6,8,12,16,24 week
measure: Quality of life
timeFrame: 0,4 week
measure: Nicotine dependence test (Fagerstrom test)
timeFrame: 10, 17 day, 4week
measure: Withdrawal symptoms
timeFrame: 1,2,3,4 week
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Dunsan Korean Medicine Hospital of Daejeon University
Study officials:
affiliation: Daejeon University
name: Choong sik Cho, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jang S, Park S, Jang BH, Park YL, Lee JA, Cho CS, Go HY, Shin YC, Ko SG. Study protocol of a pragmatic, randomised controlled pilot trial: clinical effectiveness on smoking cessation of traditional and complementary medicine interventions, including acupuncture and aromatherapy, in combination with nicotine replacement therapy. BMJ Open. 2017 Jun 2;7(5):e014574. doi: 10.1136/bmjopen-2016-014574.