Effects of AFQ056 and Nicotine in Reducing Cigarette Smoking

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00414752
Recruitment Status : Completed
First Posted : December 22, 2006
Last Update Posted : June 22, 2007
Information provided by:

December 21, 2006
December 22, 2006
June 22, 2007
September 2006
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Reduction of craving by self-report questionnaires during 3 days of voluntary smoking stoppage
Same as current
Complete list of historical versions of study NCT00414752 on Archive Site
  • Reduction in symptoms of withdrawal during 3 days of voluntary smoking stoppage
  • Reduction in nicotine consumption during 6 days of free smoking
  • Reduction in impulsivity during 3 days of free smoking and during 3 days of voluntary smoking stoppage
  • Reduction in craving during 6 days of free smoking
  • Safety and tolerability of AFQ056 during treatment periods
  • Assessment of how the body interacts with AFQ056
Same as current
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Effects of AFQ056 and Nicotine in Reducing Cigarette Smoking
A Randomized, Double Blind, Multiple Dose, Cross-Over, Placebo- and Active-Controlled Proof of Concept Study to Explore the Effects of AFQ056 and Nicotine (Active Comparator) on Craving and Withdrawal During Voluntary Smoking Abstinence in Healthy Smokers
The purpose of this study is to assess the safety and efficacy of AFQ056 and nicotine compared to placebo on craving and withdrawal symptoms during voluntary smoking stoppage in healthy smokers. This study will also assess how the body interacts with AFQ056.
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Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Smoking Abstinence
Drug: AFQ065
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
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Inclusion Criteria:

  • Healthy, male & female subjects at least 18 years and ≤60 years of age
  • In good health
  • Female subjects must be surgically sterilized or postmenopausal.
  • Current smokers not intending to quit
  • Smoke on average 15 cigarettes or more and less than 60 cigarettes a day for the past year
  • Fagerström Test for Nicotine Dependence score of at least 5 (indicates moderate to heavy smokers)
  • Willing to refrain from smoking as required
  • Written informed consent before entering the study

Exclusion Criteria:

  • History of heart disease, septum defect and/or cardiac valves surgery; clinical relevant abnormality in the ECG
  • Investigational drug treatment within 4 weeks prior to screening unless local health authority guidelines mandate a longer period
  • Women of childbearing potential, pregnant or lactating females
  • Donation of one unit (400mL) or more of blood, significant blood loss equaling at least one unit of blood within the past 2 months or a blood transfusion within 8 weeks prior to screening.
  • Coffee consumption of more than 6 cups coffee/day
  • Use of a medication within 2 weeks prior to Day 1 of each treatment period

Other protocol-defined inclusion/exclusion criteria may apply

Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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Principal Investigator: Novartis Investigator site
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP