Trial of Treatment Protocol for Smoking Cessation

Daejeon University

Status: Completed

Conditions: Smoking Cessation

Treatments: Other: NRT, counselling; Other: Traditional & Complementary Medicine treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02768025

SCKM_01

Details and patient eligibility

About

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.

Full 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.)

Enrollment: 41 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

41 participants in 2 patient groups

Intervention group

Experimental group

Description:

NRT, counselling, traditional & complementary medicine treatment (Body acupuncture, Ear acupuncture and aromatic therapy).

Treatment:

Other: Traditional & Complementary Medicine treatment

Other: NRT, counselling

Control group

Active Comparator group

Description:

NRT, counselling

Treatment:

Other: NRT, counselling