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OpenTrials
Completed

NCT Number: NCT00738595

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Evotec Study Site 2, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EVT 302

Drug

EVT 302 5 mg once daily

Placebo

Drug

Placebo to match EVT 302, 5 mg

EVT 302 plus open label Nicotine replacement

Drug

Double-blind EVT 302 plus open label nicotine replacement

Placebo plus open label Nicotine Replacement

Drug

Double-blind placebo plus open label Nicotine replacement patch 21 mg once daily.

Primary outcomes

  1. The four-week continuous quit rate over the last four weeks of treatment

    Time frame: Last 4 weeks of therapy

Secondary outcomes

  1. 7 -week abstinence

    Time frame: 7 weeks post quit day

  2. 7-day point prevalence quit rate

    Time frame: weekly for 7 weeks

  3. Daily cigarettes smoked

    Time frame: Daily

  4. Change from baseline in the number of cigarettes smoked

    Time frame: Week 8

  5. Minnesota Nicotine Withdrawal Scale

    Time frame: Weekly

  6. Brief Questionnaire of Smoking Urges

    Time frame: Weekly

  7. Modified Cigarette Evaluation Questionnaire

    Time frame: Weekly

  8. Adverse Events

    Time frame: Weekly

  9. Laboratory investigations (Haematology & biochemistry)

    Time frame: Weekly

  10. ECGs

    Time frame: Weekly

Sponsors and collaborators

Lead sponsor

Evotec Neurosciences GmbH

Industry

Collaborators

  • Clinpharm International Management Holding GmbH
  • PRA Health Sciences

Registry information

Official study title

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.

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 20, 2008
Registry last updated
May 29, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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