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CLINICAL TRIALS PROFILE FOR NICORETTE

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Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00139516	Chinese Community Smoking Cessation Project	Completed	National Heart, Lung, and Blood Institute (NHLBI)	N/A	2001-09-01	The study has two objectives/aims: Aim 1: To test the efficacy of the intervention among adult smokers with cardiovascular disease, pulmonary disease and diabetes mellitus related illnesses (later modified to Chinese adults with and without diseases); and Aim 2: To examine a set of measures (background, general health, psychosocial, and smoking process) that are associated with smoking cessation at 6 and 12 months
NCT00139516	Chinese Community Smoking Cessation Project	Completed	University of California, San Francisco	N/A	2001-09-01	The study has two objectives/aims: Aim 1: To test the efficacy of the intervention among adult smokers with cardiovascular disease, pulmonary disease and diabetes mellitus related illnesses (later modified to Chinese adults with and without diseases); and Aim 2: To examine a set of measures (background, general health, psychosocial, and smoking process) that are associated with smoking cessation at 6 and 12 months
NCT00158171	Effectiveness of Various Smoking Cessation Therapies in Reducing Smoking in Adolescents - 1	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	2002-04-01	Currently one in five high school students smokes. Smoking can harm adolescents well before they reach adulthood by causing a number of immediate, sometimes irreversible, health risks and problems. This study will compare the effectiveness of treatment with bupropion, a nicotine patch, or nicotine gum in supporting the reduction of smoking in adolescent smokers.
NCT00174499	A Pilot Drug Trial That Evaluates the Whitening Potential of Nicotine Gum	Completed	McNeil AB	Phase 4	2005-07-01	The purpose of this research study is to evaluate the effects on existing tooth stain of nicotine gum. The study will enroll adults who have visible tooth staining.
NCT00176449	A Comparison of Bupropion SR and Placebo for Smoking Cessation	Completed	VA Office of Research and Development	Phase 4	2001-04-01	The purpose of this study is to examine whether the adjunctive use of bupropion SR in the context of a psychoeducational program modified for people with schizophrenia might improve the likelihood of successful abstinence in this population. If bupropion SR is effective for reducing cigarette smoking, then it will be important to determine if decreased nicotine intake is associated with a worsening of psychotic, anxiety or depressive symptoms. In addition, it would be important to determine the effect that a reduction in nicotine stimulation would have on patient's cognitive functioning, as nicotinic receptors have been shown to regulate attention and memory function, and it is hypothesized that these functions are normalized by acute nicotine administration in people with schizophrenia
NCT00176449	A Comparison of Bupropion SR and Placebo for Smoking Cessation	Completed	University of Maryland	Phase 4	2001-04-01	The purpose of this study is to examine whether the adjunctive use of bupropion SR in the context of a psychoeducational program modified for people with schizophrenia might improve the likelihood of successful abstinence in this population. If bupropion SR is effective for reducing cigarette smoking, then it will be important to determine if decreased nicotine intake is associated with a worsening of psychotic, anxiety or depressive symptoms. In addition, it would be important to determine the effect that a reduction in nicotine stimulation would have on patient's cognitive functioning, as nicotinic receptors have been shown to regulate attention and memory function, and it is hypothesized that these functions are normalized by acute nicotine administration in people with schizophrenia
NCT00710034	Efficacy of Oral Tobacco Products Compared to a Medicinal Nicotine	Completed	National Cancer Institute (NCI)	Phase 2	2010-04-01	For the primary goals, we hypothesize that 1) the oral tobacco product will be more efficacious than the medicinal nicotine product in substituting for smoking cigarettes; 2) among non-abstainers, the oral tobacco product will lead to greater reduction in cigarette smoking than medicinal nicotine; and 3) a higher rate of oral tobacco compared to medicinal nicotine use will be observed during and beyond the treatment period. For the secondary goals, we hypothesize that 1) both products will equally reduce withdrawal symptoms and negative affect from cigarette abstinence, but smokers who are assigned to the oral tobacco product will be more likely to report liking the effects from their assigned product compared to those smokers assigned to medicinal nicotine; 2) greater physiological effects (e.g., vitals) will be observed for the oral tobacco product compared to medicinal nicotine; 3) the toxicant exposure and toxicity will be reduced dramatically when smokers switch from cigarettes to each of these products; however, this reduction will be greater with the use of medicinal nicotine; 4) although the abstinence rates will be higher for oral tobacco products, and initial product costs will be lower, relative to the medicinal nicotine intervention, the likelihood of longer duration of oral tobacco use will increase the oral tobacco cost over time for the user; and 5) switching to low-nitrosamine oral tobacco will reduce life-years lost compared to continuing smoking and will be a cost-effective (in terms of life-years saved) substitution strategy compared to medicinal nicotine.
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