SmokingCV-SMNCT01656083
The Compliance of Varenicline With Short-massage
An observational study of Smoking, run by yu hong xia at 1 site in Germany.
Trial summary
Research indicated that the relapse rate of smokers who attempted to give up smoking without drug and other assistance is up to 90-95% while the successful cessation rate may be improved a lot with assistance to quit smoking. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- How many people
- 220 participants
- Where
- 1 siteGermany
- Study dates
- May 2010to Dec 2012
- Phase
- Observational
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: In this research, professional biostatistical staffs adopt SAS program to divide groups in the trial. The sample size is calculated based on drug compliance rate. Since lack of the data related to varenicline combined SM intervention, the similar trials in the past are taken as reference, but mostly based on the experiences of the investigator's, the mean treatment time for patients using Varenicline is 4 weeks, the proportion of patients who use Varenicline for 4 weeks is about 40%; when combined SM intervention, it supposed to increase to 60% . When use 80% power and 0.05 significance for calculation, the sample size is 192, 96 for each group. Considering the drop rate is aobut 15%, 220 qualified subjects are included in random group division.
Who may be able to join
- Smoking over 10 years
- Over 10 cigarettes each day
- Age 18 to 70 years
- Have strong motivation to quit smoking
- Be suitable and willing to receive Varenicline treatment
- Be able to receive SM and willing to receive relevant information
- Sign the Informed Consent Form
Who cannot join
- Serious abnormality of liver and kidney functions
- Have serious skin allergy or mental diseases history, or any other disease not suitable for using Varenicline
- Alcohol abuse or other drug abuse
- Any concomitant illness or mental condition that could interfere with the study
- Any conditions indicating study subjects uncooperative
- Unable to receive or read SM
- Any subject that Investigators think not to be suitable for enrollment.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
MicroCO/SmokeCheck
Beijing, Beijing, 100029
xu jing, faculty, 008610-84205204
liu chao wu, master, 008610-84206185
About this study
Official title: The Compliance of Varenicline Usage and the Smoking Abstinence Rate Via Mobile Phone Text Messaging Combine With Varenicline: a Single-blind, Randomised Control Trial
Research indicated that the relapse rate of smokers who attempted to give up smoking without drug and other assistance is up to 90-95% while the successful cessation rate may be improved a lot with assistance to quit smoking. There are two kinds of measures to help smokers quit smoking: one is psychological and behavioral intervention, including the advice to quit smoking provided by doctors during daily health service and smoking cessation hotline; another is provision of drug therapy. 2008 smoking cessation Guidance plays emphasis on the effectiveness of smoking cessation of Varenicline and also on role of doctor's behavioral intervention in smoking cessation as Class A of evidence-based rating; among which, doctor's consultation (three minutes) at minimum intensity is effective; high-intensity consultation (more than ten minutes) is more effective than that of low-intensity consultation; and return visit for more than four times will distinctively improve the smoking abstinence rate. It is unrealistic to apply high-intensity and high-frequency smoking cessation intervention on all smokers due to the busy clinical work of domestic doctors. Systematic and standardized short message intervention system may be helpful to improve abstinence rate. Meanwhile, it can reduce human labor and physical resources, and improve the frequency of follow-up visit to smokers. It is observed during the process of offering smoking cessation services to smokers that, it would be one of the very effective measures to provide timely and useful information to smokers at several critical phases of smoking cessation course (such as three weeks before smoking cessation, prevention of relapse, etc.). Doctors, however, are usually passive during this period and unable to provide assistance to smokers with initiative. As people are more and more aware of the harmfulness of smoking and more and more smokers are increasingly willing to give up smoking, it is necessary to create an instant active information distribution system, which provides immediate active smoking cessation short message support through universally used mobile phone short message service to achieve the purpose of helping them quit smoking.
Read the detailed description
Study design Random, parallel and control method is adopted.
- Group division: random group division SM intervention group: SM intervention + varenicline Non-SM intervention group: varenicline
- Method design Random, parallel and control method is adopted. In intervention group, SM is delivered by a standard designed SM platform system. The interactive SM supports are involved and trained professional staff will provide guidance regularly. The drug usage in two groups are the same.
Group Baseline 1st week 2nd week 3rd week 4th week 8th week 12th week 24th week Intervention Record Smoking history, consulting SM SM SM SM + Visit SM + Telephone visit SM + Visit SM + Visit Control Visit Telephone visit Visit Visit
Study population In this research, professional biostatistical staffs adopt SAS program to divide groups in the trial. The sample size is calculated based on drug compliance rate. Since lack of the data related to varenicline combined SM intervention, the similar trials in the past are taken as reference, but mostly based on the experiences of the investigator's, the mean treatment time for patients using Varenicline is 4 weeks, the proportion of patients who use Varenicline for 4 weeks is about 40%; when combined SM intervention, it supposed to increase to 60% . When use 80% power and 0.05 significance for calculation, the sample size is 192, 96 for each group. Considering the drop rate is about 15%, 220 qualified subjects are included in random group division.
Treatment program
- Treatment program The drug administered is varenicline. This drug has been recommended as the first-line smoking-cessation drug by American smoking-cessation guide in 2008. The abstinence rate is 3.1 times higher than that of placebo [3]-109, which is the highest rate among smoking-cessation drugs at present. This drug is manufactured by Pfizer Company and should be used strictly in light of the use instruction.
- Intervention
- Contents of psychological behavior intervention 2) SM intervention
Regular SM for smoking cessation
It is active SM delivery, no need of reply. SM is delivered at 9 o'clock on the assigned day to mobile phones of target people. The frequency of delivery is as follows:
Time Frequency
1 day before smoking cessation 1pcs/d The 1st week of smoking cessation 2pcs/d The 2nd week of smoking cessation 1pcs/d The 3rd to 4th weeks of smoking cessation 1pcs/d The 2nd to 6th months of smoking cessation 1pcs/w
Objectives Primary observation index 1) Drug compliance for 4 weeks: defined as the proportion of patients who use Varenicline for 4 weeks to all the patients in this group.
Secondary observe index
- Drug compliance for 6, 8, 10 and 12 weeks: the proportion of patients using varenicline for 6, 8,10 and 12 weeks to all the patients;
- Continuous abstinence(CA) rates: These rates are defined as the proportion of participants who met abstinence criteria for weeks 9 through 12 and reported no smoking or use of tobacco products at clinic or telephone visits, confirmed by exhaled carbon monoxide measurement of 10 ppm or less at clinic visits only.
- Long-term abstinence rates: it is the rate at the follow-up of the 24th week and verified by exhaled CO test.
Safety The safety indexes include i. General items: blood pressure, heart rate, respiration ii. Blood and urine routine, liver and kidney functions iii. ECG iv. All of the recorded adverse events v. Severe adverse events: terminate trial immediately and deal with them in time.
Record and report of adverse event
- Definition
- Adverse event: any untoward medical conditions occurrence in a patient administered the drug.
- Serious adverse event: below adverse events occurrence in drug use: death, life threatened, prolong hospitalization, disabled and teratogenic.
- The relationship between adverse event and trial drug Data management
- Filling-up Case Report
- Data input
- Data lock
- Data management Statistical analysis SPSS 10.01 statistical software is adopted. Differences in treatment period between two groups were evaluated using Kaplan-Meier survival curves, with log-rank test, Cox proportional hazard models, Bilateral test is used in all of statistical test, P<0.05 is viewed to be statistical significant difference.
Parametric method is adopted for normality data and the data of homogeneity of variance, including mainly independent t test, paired t test, variance analysis, analysis of covariance, etc. For the data of non-normal distribution and uneven variance, non-parametric method is adopted, including Chi-square test, exact probability method, rank test, etc.
- Conditions
- Smoking
- Keywords
- Mobile phone text messaging (SM), Varenicline, The compliance, The abstinence rate
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SM intervention + varenicline | In intervention group, SM is delivered by a standard designed SM platform system. The interactive SM supports are involved and trained professional staff will provide guidance regularly. The drug usage in two groups are the same. | |
| Non-SM intervention group: varenicline | varenicline only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug compliance varenicline
Drug compliance for 4 weeks: defined as the proportion of patients who use Varenicline for 4 weeks to all the patients in this group.
Measured: 4weeks
Secondary outcomes (1)
Continuous abstinence(CA) rates
- Drug compliance for 6, 8, 10 and 12 weeks: the proportion of patients using varenicline for 6, 8,10 and 12 weeks to all the patients;
- Continuous abstinence(CA) rates: These rates are defined as the proportion of participants who met abstinence criteria for weeks 9 through 12 and reported no smoking or use of tobacco products at clinic or telephone visits, confirmed by exhaled carbon monoxide measurement of 10 ppm or less at clinic visits only.
- Long-term abstinence rates: it is the rate at the follow-up of the 24th week and verified by exhaled CO test.
Measured: 24weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2012 (estimated)
- Study startMay 2010
- Primary completionJul 2011
- Study completionDec 2012 (estimated)
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 SmokingStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- yu hong xia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, yu hong xia, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01656083
- Sponsor's protocol ID
- SM2010CHINA
- Acronym
- CV-SM
- Status last verified
- Jul 2012
- First submitted
- 31 Jul 2012
- Last updated
- 2 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Heckman CJ, Egleston BL, Hofmann MT. Efficacy of motivational interviewing for smoking cessation: a systematic review and meta-analysis. Tob Control. 2010 Oct;19(5):410-6. doi: 10.1136/tc.2009.033175. Epub 2010 Jul 30.
PubMed 20675688
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Compliance of Varenicline Usage and the Smoking Abstinence Rate Via Mobile Phone Text Messaging Combine With Varenicline: a Single-blind, Randomised Control Trial
- ClinicalTrials.gov ID
- NCT01656083
- Acronym / sponsor ID
- CV-SM / SM2010CHINA
- Conditions
- Smoking
- Keywords
- Mobile phone text messaging (SM), Varenicline, The compliance, The abstinence rate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- yu hong xiaUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Dec 2012 (estimated)
- First posted
- 2 Aug 2012 (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.
Research indicated that the relapse rate of smokers who attempted to give up smoking without drug and other assistance is up to 90-95% while the successful cessation rate may be improved a lot with assistance to quit smoking. There are two kinds of measures to help smokers quit smoking: one is psychological and behavioral intervention, including the advice to quit smoking provided by doctors during daily health service and smoking cessation hotline; another is provision of drug therapy. 2008 smoking cessation Guidance plays emphasis on the effectiveness of smoking cessation of Varenicline and also on role of doctor's behavioral intervention in smoking cessation as Class A of evidence-based rating; among which, doctor's consultation (three minutes) at minimum intensity is effective; high-intensity consultation (more than ten minutes) is more effective than that of low-intensity consultation; and return visit for more than four times will distinctively improve the smoking abstinence rate. It is unrealistic to apply high-intensity and high-frequency smoking cessation intervention on all smokers due to the busy clinical work of domestic doctors. Systematic and standardized short message intervention system may be helpful to improve abstinence rate. Meanwhile, it can reduce human labor and physical resources, and improve the frequency of follow-up visit to smokers. It is observed during the process of offering smoking cessation services to smokers that, it would be one of the very effective measures to provide timely and useful information to smokers at several critical phases of smoking cessation course (such as three weeks before smoking cessation, prevention of relapse, etc.). Doctors, however, are usually passive during this period and unable to provide assistance to smokers with initiative. As people are more and more aware of the harmfulness of smoking and more and more smokers are increasingly willing to give up smoking, it is necessary to create an instant active information distribution system, which provides immediate active smoking cessation short message support through universally used mobile phone short message service to achieve the purpose of helping them quit smoking.
Detailed description
Study design Random, parallel and control method is adopted.
- Group division: random group division SM intervention group: SM intervention + varenicline Non-SM intervention group: varenicline
- Method design Random, parallel and control method is adopted. In intervention group, SM is delivered by a standard designed SM platform system. The interactive SM supports are involved and trained professional staff will provide guidance regularly. The drug usage in two groups are the same.
Group Baseline 1st week 2nd week 3rd week 4th week 8th week 12th week 24th week Intervention Record Smoking history, consulting SM SM SM SM + Visit SM + Telephone visit SM + Visit SM + Visit Control Visit Telephone visit Visit Visit
Study population In this research, professional biostatistical staffs adopt SAS program to divide groups in the trial. The sample size is calculated based on drug compliance rate. Since lack of the data related to varenicline combined SM intervention, the similar trials in the past are taken as reference, but mostly based on the experiences of the investigator's, the mean treatment time for patients using Varenicline is 4 weeks, the proportion of patients who use Varenicline for 4 weeks is about 40%; when combined SM intervention, it supposed to increase to 60% . When use 80% power and 0.05 significance for calculation, the sample size is 192, 96 for each group. Considering the drop rate is about 15%, 220 qualified subjects are included in random group division.
Treatment program
- Treatment program The drug administered is varenicline. This drug has been recommended as the first-line smoking-cessation drug by American smoking-cessation guide in 2008. The abstinence rate is 3.1 times higher than that of placebo [3]-109, which is the highest rate among smoking-cessation drugs at present. This drug is manufactured by Pfizer Company and should be used strictly in light of the use instruction.
- Intervention
- Contents of psychological behavior intervention 2) SM intervention
Regular SM for smoking cessation
It is active SM delivery, no need of reply. SM is delivered at 9 o'clock on the assigned day to mobile phones of target people. The frequency of delivery is as follows:
Time Frequency
1 day before smoking cessation 1pcs/d The 1st week of smoking cessation 2pcs/d The 2nd week of smoking cessation 1pcs/d The 3rd to 4th weeks of smoking cessation 1pcs/d The 2nd to 6th months of smoking cessation 1pcs/w
Objectives Primary observation index 1) Drug compliance for 4 weeks: defined as the proportion of patients who use Varenicline for 4 weeks to all the patients in this group.
Secondary observe index
- Drug compliance for 6, 8, 10 and 12 weeks: the proportion of patients using varenicline for 6, 8,10 and 12 weeks to all the patients;
- Continuous abstinence(CA) rates: These rates are defined as the proportion of participants who met abstinence criteria for weeks 9 through 12 and reported no smoking or use of tobacco products at clinic or telephone visits, confirmed by exhaled carbon monoxide measurement of 10 ppm or less at clinic visits only.
- Long-term abstinence rates: it is the rate at the follow-up of the 24th week and verified by exhaled CO test.
Safety The safety indexes include i. General items: blood pressure, heart rate, respiration ii. Blood and urine routine, liver and kidney functions iii. ECG iv. All of the recorded adverse events v. Severe adverse events: terminate trial immediately and deal with them in time.
Record and report of adverse event
- Definition
- Adverse event: any untoward medical conditions occurrence in a patient administered the drug.
- Serious adverse event: below adverse events occurrence in drug use: death, life threatened, prolong hospitalization, disabled and teratogenic.
- The relationship between adverse event and trial drug Data management
- Filling-up Case Report
- Data input
- Data lock
- Data management Statistical analysis SPSS 10.01 statistical software is adopted. Differences in treatment period between two groups were evaluated using Kaplan-Meier survival curves, with log-rank test, Cox proportional hazard models, Bilateral test is used in all of statistical test, P<0.05 is viewed to be statistical significant difference.
Parametric method is adopted for normality data and the data of homogeneity of variance, including mainly independent t test, paired t test, variance analysis, analysis of covariance, etc. For the data of non-normal distribution and uneven variance, non-parametric method is adopted, including Chi-square test, exact probability method, rank test, etc.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SM intervention + varenicline | – | –In intervention group, SM is delivered by a standard designed SM platform system. The interactive SM supports are involved and trained professional staff will provide guidance regularly. The drug usage in two groups are the same. |
| Non-SM intervention group: varenicline | – | –varenicline only |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- In this research, professional biostatistical staffs adopt SAS program to divide groups in the trial. The sample size is calculated based on drug compliance rate. Since lack of the data related to varenicline combined SM intervention, the similar trials in the past are taken as reference, but mostly based on the experiences of the investigator's, the mean treatment time for patients using Varenicline is 4 weeks, the proportion of patients who use Varenicline for 4 weeks is about 40%; when combined SM intervention, it supposed to increase to 60% . When use 80% power and 0.05 significance for calculation, the sample size is 192, 96 for each group. Considering the drop rate is aobut 15%, 220 qualified subjects are included in random group division.
Key inclusion criteria (7 listed)
- Smoking over 10 years
- Over 10 cigarettes each day
- Age 18 to 70 years
- Have strong motivation to quit smoking
- Be suitable and willing to receive Varenicline treatment
Key exclusion criteria (7 listed)
- Serious abnormality of liver and kidney functions
- Have serious skin allergy or mental diseases history, or any other disease not suitable for using Varenicline
- Alcohol abuse or other drug abuse
- Any concomitant illness or mental condition that could interfere with the study
- Any conditions indicating study subjects uncooperative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Drug compliance varenicline
Time frame: 4weeks
Drug compliance for 4 weeks: defined as the proportion of patients who use Varenicline for 4 weeks to all the patients in this group.
1 secondary outcome
Continuous abstinence(CA) rates
Time frame: 24weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2012.
- Results publication: PubMed 20675688Heckman CJ, Egleston BL, Hofmann MT. Efficacy of motivational interviewing for smoking cessation: a systematic review and meta-analysis. Tob Control. 2010 Oct;19(5):410-6. doi: 10.1136/tc.2009.033175. Epub 2010 Jul 30.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking, run by yu hong xia at 1 site in Germany.
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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 2 Aug 2012. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug compliance varenicline (time frame: 4weeks). 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 NCT01656083, 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 2 Aug 2012.