The purpose of this study is to evaluate the safety, efficacy, and tolerability of twice daily (BID) administration of three dose strengths (1.2 mg, 1.8 mg, and 2.4 mg) of varenicline controlled release (CR) tablets in adult smokers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Varenicline CR tablet 1.2 mg BID for 7 weeks
Varenicline CR tablet 1.8 mg BID for 7 weeks
Varenicline CR tablet 2.4 mg BID for 7 weeks
Continuous abstinence from smoking for weeks 4-7, carbon monoxide confirmed
Time frame: 7 weeks
7- day point prevalence of non-smoking at week 7
Time frame: 7 days
Scores on the Minnesota Nicotine Withdrawal Scale subscales
Time frame: 7 weeks
Scores on the Modified Cigarette Evaluation Questionaire subscales
Time frame: 7 weeks
PK analysis
Time frame: 7 weeks
Safety Assessments: adverse events, C-SSRs, vital signs, body weight
Time frame: 7 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Varenicline IR tablet 1 mg BID for 7 weeks
Placebo BID for 7 weeks