Trial of Treatment Protocol for Smoking Cessation

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02768025
• Other study ID #: SCKM_01
• Status: Completed
• Phase: N/A
• First received: April 28, 2016
• Last updated: January 30, 2018
• Start date: July 1, 2016
• Est. completion date: August 31, 2017

Study information

• Verified date: January 2018
• Source: Daejeon University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: August 31, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Other:
• Traditional & Complementary Medicine treatment
Body acupuncture, Ear acupuncture and aromatic therapy
• NRT, counselling
Nicotine Replacement Therapy, counselling

Locations

Country	Name	City	State
Korea, Republic of	Dunsan Korean Medicine Hospital of Daejeon University	Daejeon

Sponsors (1)

Lead Sponsor	Collaborator
Daejeon University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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