This study will investigate the efficacy of EVT 302, a potent and selective inhibitor of Monoamine Oxidase - B, in improving quit rates in chronic cigarette smokers who are motivated to quit smoking. EVT 302 will be compared to placebo both with and without open label nicotine replacement therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
400
Evotec Study Site 2
Berlin, Germany
Evotec Study Site 3
Bochum, Germany
Evotec Study Site 8
Chemnitz, Germany
Evotec Study Site 4
Dresden, Germany
The four-week continuous quit rate over the last four weeks of treatment
Time frame: Last 4 weeks of therapy
7 -week abstinence
Time frame: 7 weeks post quit day
7-day point prevalence quit rate
Time frame: weekly for 7 weeks
Daily cigarettes smoked
Time frame: Daily
Change from baseline in the number of cigarettes smoked
Time frame: Week 8
Minnesota Nicotine Withdrawal Scale
Time frame: Weekly
Brief Questionnaire of Smoking Urges
Time frame: Weekly
Modified Cigarette Evaluation Questionnaire
Time frame: Weekly
Adverse Events
Time frame: Weekly
Laboratory investigations (Haematology & biochemistry)
Time frame: Weekly
ECGs
Time frame: Weekly
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Double-blind placebo plus open label Nicotine replacement patch 21 mg once daily.
Evotec Study Site 5
Frankfurt, Germany
Evotec Study Site 7
Görlitz, Germany
Evotec Study Site 1
Leipzig, Germany
Evotec Study Site 6
Magdeburg, Germany
Evotec Study Site 9
Potsdam, Germany