The Compliance of Varenicline With Short-massage

NCT01656083 | Unknown DMC

• 1 other identifier: SM2010CHINA
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking

Keywords

Mobile phone text messaging (SM); Varenicline; The compliance; The abstinence rate

Outcome Measures

Primary Outcomes (1)

• 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.

  4weeks

Secondary Outcomes (1)

• Continuous abstinence(CA) rates

  24weeks

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• yu hong xia: lead

Study Sites (1)

MicroCO/SmokeCheck

Beijing, Beijing, 100029, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 20675688 RESULT

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of respirtory medicine&smoking cessation clininc

Study Record Dates

• First Submitted: July 31, 2012
• First Posted: August 2, 2012
• Study Start: May 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: December 1, 2012
• Last Updated: August 2, 2012

Record last verified: 2012-07

Locations

DE (1)