In smokers who are motivated to stop smoking, treatment with lorcaserin compared with placebo will provide greater abstinence as measured by the last 4 weeks of treatment (Weeks 9-12). The target quit date was Day 15.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
603
Percentage of Participants With Abstinence for the Last 4 Weeks of Treatment From Weeks 9-12
Primary efficacy was assessed as the CO (carbon monoxide)-confirmed continuous abstinence rate for the last 4 weeks of treatment (Month 3: Weeks 9 through 12), defined as no reported smoking (not even a puff) or other nicotine use, verified by end expiratory CO levels \<= 10 ppm.
Time frame: Week 9 - Week 12
Abstinence During Weeks 3-12
The CO (carbon monoxide)-confirmed continuous abstinence rate for Weeks 3 through 12, defined as no reported smoking (not even a puff) or other nicotine use, verified by end expiratory CO levels \<= 10 ppm
Time frame: Week 3 to Week 12
The 7 Day Point Prevalence or Weekly Abstinence at Week 8
The CO (carbon monoxide)-confirmed continuous abstinence rate at for the 7-day period preceding the Week 8 visit, defined as no reported smoking (not even a puff) or other nicotine use, verified by end expiratory CO levels \<= 10 ppm
Time frame: Week 8
The 7 Day Point Prevalence or Weekly Abstinence at Week 12
The CO (carbon monoxide)-confirmed continuous abstinence rate at for the 7-day period preceding the Week 12 visit, defined as no reported smoking (not even a puff) or other nicotine use, verified by end expiratory CO levels \<= 10 ppm
Time frame: Week 12
Body Weight
Change in body weight from Week 1 (baseline) to Week 12
Time frame: Baseline to Week 12
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