Phase II Study to Evaluate the Effectiveness of EVT 302 in Smoking Cessation.

Study Overview
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Brief Summary
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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.

Official Title
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Phase II Multicentre, Randomised, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Effectiveness of EVT 302 in Smoking Cessation, Effect on it Own and in Combination With Open Label Nicotine Replacement Therapy.

Conditions
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Smoking Cessation

Intervention / Treatment
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* Drug: EVT 302
* Drug: Placebo
* Drug: EVT 302 plus open label Nicotine replacement
* Drug: Placebo plus open label Nicotine Replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Smoker of at least 10 cigarettes daily Motivated to quit smoking Reports at least one unsuccessful attempt to quit in the last 2 years In generally good health Provides written informed consent to participate in the sudy Exclusion Criteria: Pregnant or nursing females. Women of child-bearing potential must agree to use acceptable contraceptive precautions (contraceptive pill and one barrier method)during the study and for 2-months thereafter History of anaphylaxis History of alcohol or drug abuse History of or current significant medical or psychiatric disorder History or presence of cataract or abnormality identified by slit lamp investigation Use of other MAO inhibitors, pethidine, SSRIs, tricyclic antidepressants,nasal or oral decongestants or cold medicines containing ephedrine, pseudoephedrine or other sympathomimetics. Any medicine contraindicated for use with MAO inhibitors. Have or be a carrier of hepatitis B or c or HIV 1 or 2 Use of tobacco products other than cigarettes Use of nicotine replacement therapy in the past month Received an investigational drug in the past 30 days Previous participation in a study with a MAO-B inhibitor

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>EVT 302, 5 mg once Daily | Drug: EVT 302<br>* EVT 302 5 mg once daily<br>|
| Placebo Comparator: 2<br>Placebo once daily | Drug: Placebo<br>* Placebo to match EVT 302, 5 mg<br>|
| Experimental: 3<br>EVT 302 plus open label Nicotine replacement | Drug: EVT 302 plus open label Nicotine replacement<br>* Double-blind EVT 302 plus open label nicotine replacement<br>|
| Active Comparator: 4<br>Placebo plus nicotine replacement therapy | Drug: Placebo plus open label Nicotine Replacement<br>* Double-blind placebo plus open label Nicotine replacement patch 21 mg once daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The four-week continuous quit rate over the last four weeks of treatment |  | Last 4 weeks of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7 -week abstinence |  | 7 weeks post quit day | 
| 7-day point prevalence quit rate |  | weekly for 7 weeks | 
| Daily cigarettes smoked |  | Daily | 
| Change from baseline in the number of cigarettes smoked |  | Week 8 | 
| Minnesota Nicotine Withdrawal Scale |  | Weekly | 
| Brief Questionnaire of Smoking Urges |  | Weekly | 
| Modified Cigarette Evaluation Questionnaire |  | Weekly | 
| Adverse Events |  | Weekly | 
| Laboratory investigations (Haematology & biochemistry) |  | Weekly | 
| ECGs |  | Weekly | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking Cessation