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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by China-Japan Friendship Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
yu hong xia, China-Japan Friendship Hospital
ClinicalTrials.gov Identifier:
NCT01656083
First received: July 31, 2012
Last updated: August 1, 2012
Last verified: July 2012
  Purpose

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
Smoking

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by China-Japan Friendship Hospital:

Primary Outcome Measures:
  • Drug compliance varenicline [ Time Frame: 4weeks ] [ Designated as safety issue: Yes ]
    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:
  • Continuous abstinence(CA) rates [ Time Frame: 24weeks ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 220
Study Start Date: May 2010
Estimated Study Completion Date: December 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01656083

Locations
Germany
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
  More Information

No publications provided

Responsible Party: yu hong xia, Department of respirtory medicine&smoking cessation clininc, China-Japan Friendship Hospital
ClinicalTrials.gov Identifier: NCT01656083     History of Changes
Other Study ID Numbers: SM2010CHINA
Study First Received: July 31, 2012
Last Updated: August 1, 2012
Health Authority: China: Ethics Committee

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

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

ClinicalTrials.gov processed this record on November 20, 2014