Phase II Study to Evaluate the Effectiveness of EVT 302 in Smoking Cessation.
NCT ID: NCT00738595
Last Updated: 2009-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
400 participants
INTERVENTIONAL
2008-08-31
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
EVT 302, 5 mg once Daily
EVT 302
EVT 302 5 mg once daily
2
Placebo once daily
Placebo
Placebo to match EVT 302, 5 mg
3
EVT 302 plus open label Nicotine replacement
EVT 302 plus open label Nicotine replacement
Double-blind EVT 302 plus open label nicotine replacement
4
Placebo plus nicotine replacement therapy
Placebo plus open label Nicotine Replacement
Double-blind placebo plus open label Nicotine replacement patch 21 mg once daily.
Interventions
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EVT 302
EVT 302 5 mg once daily
Placebo
Placebo to match EVT 302, 5 mg
EVT 302 plus open label Nicotine replacement
Double-blind EVT 302 plus open label nicotine replacement
Placebo plus open label Nicotine Replacement
Double-blind placebo plus open label Nicotine replacement patch 21 mg once daily.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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PRA Health Sciences
INDUSTRY
Clinpharm International Management Holding GmbH
UNKNOWN
Evotec Neurosciences GmbH
INDUSTRY
Responsible Party
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Evotec
Principal Investigators
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H D Stahl, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
ClinPharm International, Leipzig, Germany
Locations
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Evotec Study Site 2
Berlin, , Germany
Evotec Study Site 3
Bochum, , Germany
Evotec Study Site 8
Chemnitz, , Germany
Evotec Study Site 4
Dresden, , Germany
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
Countries
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References
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Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.
Other Identifiers
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EUDRACT No.: 2008-002472-99
Identifier Type: -
Identifier Source: secondary_id
EVT 302/3009
Identifier Type: -
Identifier Source: org_study_id