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

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Evotec Neurosciences GmbH
• Collaborators: Clinpharm International Management Holding GmbH; PRA Health Sciences
• Treatments: Nicotine

Criteria

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