Trial of Treatment Protocol for Smoking Cessation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02768025|
Recruitment Status : Completed
First Posted : May 11, 2016
Last Update Posted : February 1, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation||Other: Traditional & Complementary Medicine treatment Other: NRT, counselling||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Trial of Treatment Protocol for Smoking Cessation: A Pragmatic Randomized Controlled Pilot Study|
|Actual Study Start Date :||July 1, 2016|
|Actual Primary Completion Date :||July 1, 2017|
|Actual Study Completion Date :||August 31, 2017|
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 therapyOther: NRT, counselling
Nicotine Replacement Therapy, counselling
Active Comparator: Control group
Other: NRT, counselling
Nicotine Replacement Therapy, counselling
- Continuous Abstinence Rate [ Time Frame: 4 week ]endpoint of treatment
- 7-day Point Prevalence Abstinence [ Time Frame: 6,8,12,16,24 week ]follow-up measure
- Prolonged Abstinence Rate [ Time Frame: 3,6 month ]follow-up measure
- Program participation rate [ Time Frame: 0,7,10,14,17 day, 3,4,6,8,12,16,24 week ]each treatment and follow-up
- Amount of smoking [ Time Frame: 0,7,10,14,17 day, 3,4,6,8,12,16,24 week ]each treatment and follow-up
- Tobacco craving [ Time Frame: 0,7,10,14,17 day, 3,4,6,8,12,16,24 week ]each treatment and follow-up
- 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
- Quality of life [ Time Frame: 0,4 week ]beginning and endpoint of treatment
- Nicotine dependence test (Fagerstrom test) [ Time Frame: 10, 17 day, 4week ]
- Withdrawal symptoms [ Time Frame: 1,2,3,4 week ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02768025
|Korea, Republic of|
|Dunsan Korean Medicine Hospital of Daejeon University|
|Daejeon, Korea, Republic of, 35235|
|Principal Investigator:||Choong sik Cho, Doctor||Dunsan Korean Medicine Hospital of Daejeon University|