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Effects of AFQ056 and Nicotine in Reducing Cigarette Smoking

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00414752
First Posted: December 22, 2006
Last Update Posted: June 22, 2007
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.
Information provided by:
Novartis
  Purpose
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.

Condition Intervention Phase
Smoking Abstinence Drug: AFQ065 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Reduction of craving by self-report questionnaires during 3 days of voluntary smoking stoppage

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 36
Study Start Date: September 2006
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00414752


Locations
Germany
Novartis Investigative Site
Nuernberg, Germany
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Investigator site
  More Information

ClinicalTrials.gov Identifier: NCT00414752     History of Changes
Other Study ID Numbers: CAFQ056A2109
First Submitted: December 21, 2006
First Posted: December 22, 2006
Last Update Posted: June 22, 2007
Last Verified: June 2007

Keywords provided by Novartis:
Smoking, abstinence, craving, smoker, AFQ056, nicotine, placebo

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action