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Single-dose pharmacokinetics with a new oral nicotine replacement product and Nicorette® gum.
The study is a single-dose, randomized, cross-over study. The investigational products will be given as single doses at separate visits. The product administrations comprise 30 minutes of chewing. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits. Before and after the start of product administration at each treatment visit, blood will be sampled for pharmacokinetic analyses, pre-dose, and during 8 hours after start of product administration. Used gums will be collected and analyzed to determine the amount of remaining nicotine. Subjects will also be monitored to capture any adverse events that may occur. Treatment labels will be concealed from subjects, study personnel, monitor, and analysts.
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
McNeil AB Clinical Pharmacology R&D
Johnson & Johnson Consumer & Personal Products Worldwide
Published on BioPortfolio: 2014-08-27T03:12:36-0400
The purpose of the study is to learn more about tobacco dependence and nicotine metabolism in African-Americans and whites, by studying to see if how fast a person metabolizes nicotine (ho...
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To test if smokeless tobacco is more effective than nicotine buccal tablets in smoking cessation compared with a control group with low dose nicotine patches. Also retreatment will be tes...
The proposed work will advance the understanding and effectiveness of tobacco dependence treatment and result in more smokers quitting successfully.
Nicotine addiction is the proximate cause of disease and death from cigarette smoking. In 1994, we proposed reducing the nicotine content of cigarettes to non-addicting levels to reduce the risk of yo...
A retrospective analysis of the association between providing nicotine replacement therapy at admission and motivation to quit and nicotine withdrawal symptoms during an inpatient psychiatric hospitalization.
Psychiatric patients have high tobacco use prevalence, dependence, and withdrawal severity. A tobacco-free psychiatric hospitalization necessitates the management of nicotine withdrawal (NW) for tobac...
There is evidence suggesting that certain subgroups of people who use tobacco do not receive tobacco pharmacology as consistently as others.
Tobacco is highly addictive and after the development of dependence it is difficult to quit smoking. Therefore, it is important to understand the factors that play a role in the initiation of smoking....
The nicotine metabolite ratio (NMR) is a biomarker that represents individual variation in the speed that nicotine is metabolized. The rate of nicotine metabolism alters smoking behavior (e.g., amount...
Nicotine is highly toxic alkaloid. It is the prototypical agonist at nicotinic cholinergic receptors where it dramatically stimulates neurons and ultimately blocks synaptic transmission. Nicotine is also important medically because of its presence in tobacco smoke.
Tobacco used to the detriment of a person's health or social functioning. Tobacco dependence is included.
SMOKING of non-TOBACCO (or NICOTINE-containing) substances.
A plant genus of the family SOLANACEAE. Members contain NICOTINE and other biologically active chemicals; its dried leaves are used for SMOKING.
The N-glucuronide conjugate of cotinine is a major urinary metabolite of NICOTINE. It thus serves as a biomarker of exposure to tobacco SMOKING. It has CNS stimulating properties.
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Top 10 biotech and pharmaceutical companies worldwide based on market value in 2015 2015 ranking of the global top 10 biotech and pharmaceutical companies based on revenue (in billion U.S. dollars) Johnson & Johnson, U.S. 74...