Trial of Treatment Protocol for Smoking Cessation

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

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Other: Traditional & Complementary Medicine treatment; Other: NRT, counselling

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.)

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daejeon, Korea, Republic of, 35235
    • Dunsan Korean Medicine Hospital of Daejeon University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Daejeon University
• Investigators: Principal Investigator: Choong sik Cho, Doctor, Daejeon University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): August 31, 2017

Study Registration Dates

• First Submitted: April 28, 2016
• First Submitted That Met QC Criteria: May 8, 2016
• First Posted (Estimate): May 11, 2016

Study Record Updates

• Last Update Posted (Actual): February 1, 2018
• Last Update Submitted That Met QC Criteria: January 30, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: acupuncture; smoking cessation; Korean Medicine; tobacco control; Traditional & Complementary Medicine
• Other Study ID Numbers: SCKM_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is confidential.