Trial of Treatment Protocol for Smoking Cessation | NCT02768025

Studies
Trial of Treatment Protocol for Smoking Cessation

NCT02768025

Sponsor

Daejeon University

Status

Completed

Last Update Posted

Feb 1, 2018Actual

Enrollment

41Actual

Phase

Not Applicable

Conditions

Smoking Cessation

Interventions

Traditional & Complementary Medicine treatment
NRT, counselling

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2016Actual

Primary Completion Date

Jul 1, 2017Actual

Completion Date

Aug 31, 2017Actual

First Submitted Date

Apr 28, 2016

First Submission Date that Met QC Criteria

May 8, 2016

First Posted Date

May 11, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2018

Last Update Posted Date

Feb 1, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sunju Park, Medical Doctor, Professor, Daejeon UniversityPrincipal Investigator

Lead Sponsor

Daejeon UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

41Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention group	Experimental	NRT, counselling, traditional & complementary medicine treatment (Body acupuncture, Ear acupuncture and aromatic therapy).	Other: Traditional & Complementary Medicine treatment Other: NRT, counselling
Control group	Active Comparator	NRT, counselling	Other: NRT, counselling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Traditional & Complementary Medicine treatment	Other	Body acupuncture, Ear acupuncture and aromatic therapy	Intervention group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Continuous Abstinence Rate	endpoint of treatment	4 week

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Choong sik Cho, Doctor	Daejeon University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dunsan Korean Medicine Hospital of Daejeon University		Daejeon		35235	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28576892	Derived	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.

ID	Term
D015438	Health Behavior
D001519	Behavior

ID	Term
D000095488	Nicotine Replacement Therapy
D003376	Counseling

ID	Term
D004358	Drug Therapy
D013812	Therapeutics
D008605	Mental Health Services
D004191	Behavioral Disciplines and Activities