Smoking CessationNCT02768025
Trial of Treatment Protocol for Smoking Cessation
A study testing Traditional & Complementary Medicine treatment and NRT, counselling in people with Smoking Cessation, run by Daejeon University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Traditional & Complementary Medicine treatment and NRT, counselling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2016to 31 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1) having willing to stop smoking 2) currently smoking and applying one of the following
Who cannot join
- 1) suffering in the last 2 weeks cardiovascular disease or Severe arrhythmias, unstable angina 2) suffering from severe arrhythmia
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Dunsan Korean Medicine Hospital of Daejeon University
Daejeon, 35235
About this study
Official title: Trial of Treatment Protocol for Smoking Cessation: A Pragmatic Randomized Controlled Pilot Study
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.
Read more
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.
Read the 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.)
- Conditions
- Smoking Cessation
- Being tested
- Traditional & Complementary Medicine treatment, NRT, counselling
- Keywords
- smoking cessation, tobacco control, acupuncture, Korean Medicine, Traditional & Complementary Medicine
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional & Complementary Medicine treatmentOther
Body acupuncture, Ear acupuncture and aromatic therapy
NRT, counsellingOther
Nicotine Replacement Therapy, counselling
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | NRT, counselling, traditional \& complementary medicine treatment (Body acupuncture, Ear acupuncture and aromatic therapy). Receives: Other: Traditional & Complementary Medicine treatment; Other: NRT, counselling |
| Control group | Active comparator | NRT, counselling Receives: Other: NRT, counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous Abstinence Rate
endpoint of treatment
Measured: 4 week
Secondary outcomes (9)
7-day Point Prevalence Abstinence
follow-up measure
Measured: 6,8,12,16,24 week
Prolonged Abstinence Rate
follow-up measure
Measured: 3,6 month
Program participation rate
each treatment and follow-up
Measured: 0,7,10,14,17 day, 3,4,6,8,12,16,24 week
Amount of smoking
each treatment and follow-up
Measured: 0,7,10,14,17 day, 3,4,6,8,12,16,24 week
Tobacco craving
each treatment and follow-up
Measured: 0,7,10,14,17 day, 3,4,6,8,12,16,24 week
Exhaled Carbon monoxide monoxide
each treatment and follow-up
Measured: 0,7,10,14,17 day, 3,4,6,8,12,16,24 week
Quality of life
beginning and endpoint of treatment
Measured: 0,4 week
Nicotine dependence test (Fagerstrom test)
Measured: 10, 17 day, 4week
Withdrawal symptoms
Measured: 1,2,3,4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study start1 Jul 2016
- Primary completion1 Jul 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daejeon University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sunju Park, Daejeon University
- Investigators
- Choong sik Cho, Doctor, Principal investigator, Daejeon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768025
- Sponsor's protocol ID
- SCKM_01
- Status last verified
- Jan 2018
- First submitted
- 28 Apr 2016
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: This is confidential.
Publications
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.
PubMed 28576892
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Treatment Protocol for Smoking Cessation: A Pragmatic Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT02768025
- Acronym / sponsor ID
- SCKM_01
- Conditions
- Smoking Cessation
- Keywords
- smoking cessation, tobacco control, acupuncture, Korean Medicine, Traditional & Complementary Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Daejeon UniversityUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 11 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Traditional & Complementary Medicine treatment, Other: NRT, counsellingNRT, counselling, traditional \& complementary medicine treatment (Body acupuncture, Ear acupuncture and aromatic therapy). |
| Control group | Active comparator | Other: NRT, counsellingNRT, counselling |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) having willing to stop smoking 2) currently smoking and applying one of the following
Key exclusion criteria (1 listed)
- 1) suffering in the last 2 weeks cardiovascular disease or Severe arrhythmias, unstable angina 2) suffering from severe arrhythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional & Complementary Medicine treatmentBody acupuncture, Ear acupuncture and aromatic therapy | Other | Intervention group |
| NRT, counsellingNicotine Replacement Therapy, counselling | Other | Control group, Intervention group |
Primary outcome
Continuous Abstinence Rate
Time frame: 4 week
endpoint of treatment
9 secondary outcomes
7-day Point Prevalence Abstinence
Time frame: 6,8,12,16,24 week
Prolonged Abstinence Rate
Time frame: 3,6 month
Program participation rate
Time frame: 0,7,10,14,17 day, 3,4,6,8,12,16,24 week
Amount of smoking
Time frame: 0,7,10,14,17 day, 3,4,6,8,12,16,24 week
Tobacco craving
Time frame: 0,7,10,14,17 day, 3,4,6,8,12,16,24 week
Exhaled Carbon monoxide monoxide
Time frame: 0,7,10,14,17 day, 3,4,6,8,12,16,24 week
Quality of life
Time frame: 0,4 week
Nicotine dependence test (Fagerstrom test)
Time frame: 10, 17 day, 4week
Withdrawal symptoms
Time frame: 1,2,3,4 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
- Derived from this study: PubMed 28576892Jang 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.
- Individual participant dataSharing planned: No. This is confidential.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Choong sik Cho, Doctor principal investigator
Daejeon University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional & Complementary Medicine treatment and NRT, counselling in people with Smoking Cessation, run by Daejeon University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous Abstinence Rate (time frame: 4 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02768025, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2018.