ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Sunju Park, Daejeon University

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.


Condition or disease Intervention/treatment Phase
Smoking Cessation Other: Traditional & Complementary Medicine treatment Other: NRT, counselling Not Applicable

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  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Continuous Abstinence Rate [ Time Frame: 4 week ]
    endpoint of treatment


Secondary Outcome Measures :
  1. 7-day Point Prevalence Abstinence [ Time Frame: 6,8,12,16,24 week ]
    follow-up measure

  2. Prolonged Abstinence Rate [ Time Frame: 3,6 month ]
    follow-up measure

  3. Program participation rate [ Time Frame: 0,7,10,14,17 day, 3,4,6,8,12,16,24 week ]
    each treatment and follow-up

  4. Amount of smoking [ Time Frame: 0,7,10,14,17 day, 3,4,6,8,12,16,24 week ]
    each treatment and follow-up

  5. Tobacco craving [ Time Frame: 0,7,10,14,17 day, 3,4,6,8,12,16,24 week ]
    each treatment and follow-up

  6. 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

  7. Quality of life [ Time Frame: 0,4 week ]
    beginning and endpoint of treatment

  8. Nicotine dependence test (Fagerstrom test) [ Time Frame: 10, 17 day, 4week ]
  9. Withdrawal symptoms [ Time Frame: 1,2,3,4 week ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Locations
Korea, Republic of
Dunsan Korean Medicine Hospital of Daejeon University
Daejeon, Korea, Republic of, 35235
Sponsors and Collaborators
Daejeon University
Investigators
Principal Investigator: Choong sik Cho, Doctor Dunsan Korean Medicine Hospital of Daejeon University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sunju Park, Medical Doctor, Professor, Daejeon University
ClinicalTrials.gov Identifier: NCT02768025     History of Changes
Other Study ID Numbers: SCKM_01
First Posted: May 11, 2016    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is confidential.

Keywords provided by Sunju Park, Daejeon University:
smoking cessation
tobacco control
acupuncture
Korean Medicine
Traditional & Complementary Medicine