Title |
The efficacy and safety of a nicotine conjugate vaccine (NicVAX®) or placebo co-administered with varenicline (Champix®) for smoking cessation: study protocol of a phase IIb, double blind, randomized, placebo controlled trial
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Published in |
BMC Public Health, December 2012
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DOI | 10.1186/1471-2458-12-1052 |
Pubmed ID | |
Authors |
Philippe HJ Hoogsteder, Daniel Kotz, Paul I van Spiegel, Wolfgang Viechtbauer, Ruth Brauer, Paul D Kessler, Matthew W Kalnik, Raafat EF Fahim, Onno CP van Schayck |
Abstract |
A potential new treatment in smoking cessation and relapse prevention is nicotine vaccination which is based on active immunization against the nicotine molecule. This immunization will elicit the immune system to produce nicotine-specific antibodies that sequester nicotine in the blood stream, after inhaling tobacco products. The resulting antibody-antigen is too large to cross the blood-brain barrier and is therefore postulated to attenuate the rewarding effect of nicotine by preventing the latter from reaching its receptors in the brain and causing the release of dopamine. The aim of this paper is to describe the design of a phase IIb, multi-center, double blind, randomized, placebo controlled trial to assess the efficacy of the nicotine vaccine NicVAX® co-administered with varenicline (Champix®) and intensive counseling as an aid in smoking cessation and relapse prevention. |
X Demographics
Geographical breakdown
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Unknown | 3 | 100% |
Demographic breakdown
Type | Count | As % |
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Members of the public | 3 | 100% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
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Denmark | 1 | 2% |
Canada | 1 | 2% |
Unknown | 63 | 97% |
Demographic breakdown
Readers by professional status | Count | As % |
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Student > Master | 10 | 15% |
Student > Ph. D. Student | 8 | 12% |
Other | 6 | 9% |
Student > Bachelor | 6 | 9% |
Researcher | 6 | 9% |
Other | 12 | 18% |
Unknown | 17 | 26% |
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Medicine and Dentistry | 21 | 32% |
Psychology | 6 | 9% |
Agricultural and Biological Sciences | 5 | 8% |
Pharmacology, Toxicology and Pharmaceutical Science | 3 | 5% |
Nursing and Health Professions | 2 | 3% |
Other | 9 | 14% |
Unknown | 19 | 29% |