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The Compliance of Varenicline With Short-massage (CV-SM)

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. Identifier: NCT01656083
Recruitment Status : Unknown
Verified July 2012 by yu hong xia, China-Japan Friendship Hospital.
Recruitment status was:  Recruiting
First Posted : August 2, 2012
Last Update Posted : August 2, 2012
Information provided by (Responsible Party):
yu hong xia, China-Japan Friendship Hospital

Brief 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. 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.

Condition or disease

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Study Type : Observational
Estimated Enrollment : 220 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
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
Study Start Date : May 2010
Actual Primary Completion Date : July 2011
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Continuous abstinence(CA) rates [ Time Frame: 24weeks ]
    1. 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;
    2. 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.
    3. Long-term abstinence rates: it is the rate at the follow-up of the 24th week and verified by exhaled CO test.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.

Inclusion Criteria:

  1. Smoking over 10 years
  2. Over 10 cigarettes each day
  3. Age 18 to 70 years
  4. Have strong motivation to quit smoking
  5. Be suitable and willing to receive Varenicline treatment
  6. Be able to receive SM and willing to receive relevant information
  7. Sign the Informed Consent Form

Exclusion Criteria:

  1. Serious abnormality of liver and kidney functions
  2. Have serious skin allergy or mental diseases history, or any other disease not suitable for using Varenicline
  3. Alcohol abuse or other drug abuse
  4. Any concomitant illness or mental condition that could interfere with the study
  5. Any conditions indicating study subjects uncooperative
  6. Unable to receive or read SM
  7. Any subject that Investigators think not to be suitable for enrollment.

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 identifier (NCT number): NCT01656083

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MicroCO/SmokeCheck Recruiting
Beijing, Germany, 100029
Contact: xu jing, faculty    008610-84205204      
Contact: liu chao wu, master    008610-84206185      
Sub-Investigator: chen xin, MD         
Sub-Investigator: liu chao wu, MD         
Sub-Investigator: liu chao wu, Master         
Sub-Investigator: su nan, MD         
Principal Investigator: yu hong xia, MD         
Sub-Investigator: lin jiang tao, MD         
Sub-Investigator: wang tao, MD         
Principal Investigator: yuan jiang, PHD         
Principal Investigator: YAN YANG, PHD         
Sponsors and Collaborators
yu hong xia

Publications of Results:
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Responsible Party: yu hong xia, Department of respirtory medicine&smoking cessation clininc, China-Japan Friendship Hospital Identifier: NCT01656083     History of Changes
Other Study ID Numbers: SM2010CHINA
First Posted: August 2, 2012    Key Record Dates
Last Update Posted: August 2, 2012
Last Verified: July 2012

Keywords provided by yu hong xia, China-Japan Friendship Hospital:
Mobile phone text messaging (SM)
The compliance
The abstinence rate

Additional relevant MeSH terms:
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Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs