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OpenTrials
Completed

NCT Number: NCT00736047

Study to Evaluate the Efficacy, Safety, Tolerability and Immunogenicity of 100µg NIC002 Vaccine in Cigarette Smokers Who Are Motivated to Quit Smoking.

This study is designed to determine the efficacy of high nicotine-specific antibody titers in smoking cessation.

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Key information

Conditions

Smokers Behavior Health Behavior Smoking Cessation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Mainz, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Healthy male and female smoking subjects age 18 to 65 years of age
  • Subjects must be smoking 10 or more cigarettes per day during the past 12 months
  • The exhaled breath carbon monoxide (CO) concentration must be 10 ppm or more at screening. Urine cotinine at screening must be positive.
  • The Fagerström Test for Nicotine Dependence (FTND) score of 5 or above at screening.

Exclusion criteria

  • Attempted to quit smoking in the three (3) months.
  • Prior use of smoking cessation aid.

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

NIC002

Biological

Placebo

Biological

Primary outcomes

  1. Smoking status

    Time frame: 12 weeks

  2. Exhaled carbon monoxide

    Time frame: 12 weeks

Secondary outcomes

  1. Smoking status at various time intervals from target quit date to the end of the study

    Time frame: 52 weeks

  2. Safety and tolerability

    Time frame: 52 weeks

  3. Immunogenicity (specific anti-nicotine antibodies in serum)

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Double Blind, Placebo-controlled, Multi-centre Study to Evaluate the Efficacy, Safety, Tolerability and Immunogenicity of Repeated s.c Administrations of 100µg NIC002 Vaccine in Cigarette Smokers Who Are Motivated to Quit Smoking.

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 15, 2008
Registry last updated
Mar 21, 2017

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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