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

Overview

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.

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2009

Interventions

  • Drug: EVT 302
    • EVT 302 5 mg once daily
  • Drug: Placebo
    • Placebo to match EVT 302, 5 mg
  • Drug: EVT 302 plus open label Nicotine replacement
    • Double-blind EVT 302 plus open label nicotine replacement
  • Drug: Placebo plus open label Nicotine Replacement
    • Double-blind placebo plus open label Nicotine replacement patch 21 mg once daily.

Arms, Groups and Cohorts

  • Experimental: 1
    • EVT 302, 5 mg once Daily
  • Placebo Comparator: 2
    • Placebo once daily
  • Experimental: 3
    • EVT 302 plus open label Nicotine replacement
  • Active Comparator: 4
    • Placebo plus nicotine replacement therapy

Clinical Trial Outcome Measures

Primary Measures

  • The four-week continuous quit rate over the last four weeks of treatment
    • Time Frame: Last 4 weeks of therapy

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Evotec Neurosciences GmbH
  • Collaborator
    • PRA Health Sciences
  • Provider of Information About this Clinical Study
    • Dr S P Jones, VP Clinical Development, Evotec
  • Overall Official(s)
    • H D Stahl, MD, PhD, Principal Investigator, ClinPharm International, Leipzig, Germany

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