NCT02768025

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
Last Updated

February 1, 2018

Status Verified

January 1, 2018

Enrollment Period

1 year

First QC Date

April 28, 2016

Last Update Submit

January 30, 2018

Conditions

Smoking Cessation

Keywords

smoking cessationtobacco controlacupunctureKorean MedicineTraditional & Complementary Medicine

Outcome Measures

Primary Outcomes (1)

  • Continuous Abstinence Rate

    endpoint of treatment

    4 week

Secondary Outcomes (9)

  • 7-day Point Prevalence Abstinence

    6,8,12,16,24 week

  • Prolonged Abstinence Rate

    3,6 month

  • Program participation rate

    0,7,10,14,17 day, 3,4,6,8,12,16,24 week

  • Amount of smoking

    0,7,10,14,17 day, 3,4,6,8,12,16,24 week

  • Tobacco craving

    0,7,10,14,17 day, 3,4,6,8,12,16,24 week

  • +4 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

NRT, counselling, traditional \& complementary medicine treatment (Body acupuncture, Ear acupuncture and aromatic therapy).

Other: Traditional & Complementary Medicine treatmentOther: NRT, counselling

Control group

ACTIVE COMPARATOR

NRT, counselling

Other: NRT, counselling

Interventions

Traditional & Complementary Medicine treatmentOTHER

Body acupuncture, Ear acupuncture and aromatic therapy

Intervention group
NRT, counsellingOTHER

Nicotine Replacement Therapy, counselling

Control groupIntervention group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) having willing to stop smoking 2) currently smoking and applying one of the following

You may not qualify if:

  • \) suffering in the last 2 weeks cardiovascular disease or Severe arrhythmias, unstable angina 2) suffering from severe arrhythmia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dunsan Korean Medicine Hospital of Daejeon University

Daejeon, 35235, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 28576892DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Nicotine Replacement TherapyCounseling

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeuticsMental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Choong sik Cho, Doctor

    Daejeon University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, Professor

Study Record Dates

First Submitted

April 28, 2016

First Posted

May 11, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2017

Study Completion

August 31, 2017

Last Updated

February 1, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

This is confidential.

Locations

KR(1)