Varenicline will increase smoking cessation rate after treatment of three months

Condition	Intervention	Phase
Smoking	Drug: Varenicline	Phase III

Further Study Details: 

Primary Outcomes: 4 week CQR (Continuous Quit Rate) in the last 4 weeks of treatment (9th-12th week)
Secondary Outcomes: Continuous Abstinence: quit since 9th to 24th week; Long Term Quit Rate: 9th to 24th week, allowing 6 smoking days; 1 week point prevalence: for all 14 visits during study; Patient-reported outcome: MNWS, BQSU, SEI, SCQOL
Expected Total Enrollment:  250

250 patients, aged 18 to 75, will be recruited in Taiwan and South Korea, randomized into study and placebo groups. After tests of renal function, liver function, urine analysis and EKG, Varenicline is given and titrates up to 1 mg bid in one week. The treatment period is 3 months, follow-up period is 3 months after treatment.

Smoking cessation is considered as successful if a patient does not smoke during 9-12 week. Use intension-to-treat method to calculate the abstinence rate.

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• smoking >= 10 cigarette/day over one year
• quit smoking less than 3 months in the past year
• not use of smoking cessation medication for recent 12 months
• woman willing to use birth control

Exclusion Criteria:

• cancer
• alcoholism or addictive drug user
• psychiatric disease
• depression within 12 months
• CAD in 6 months, MI, PTCA or CABG
• active Peptic ulcer
• severe COPD
• uncontrolled hypertension
• pregnant or nursing woman

Please refer to this study by ClinicalTrials.gov identifier  NCT00155298

Fei-Ran Guo, MD      886-2-2312-3456  Ext. 8772    fjguo@ha.mc.ntu.edu.tw

Taiwan
      Natioanl Taiwan University Hospital, Taipei,  Taiwan; Recruiting

Study chairs or principal investigators

Fei-Ran Guo, MD,  Principal Investigator,  Department of Family Medicine, National Taiwan University Hospital   

Study ID Numbers:  931111
Last Updated:  September 9, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00155298
Health Authority: Taiwan: Department of Health
ClinicalTrials.gov processed this record on 2005-09-13