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Last Updated: January 25, 2020

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CLINICAL TRIALS PROFILE FOR NICOTINE

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505(b)(2) Clinical Trials for Nicotine

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT00224419 Testing Pharmacological Therapies for Pregnant Smokers Terminated National Cancer Institute (NCI) Phase 4 2003-06-01 Nicotine dependence has not been sufficiently addressed in current state-of-the-science cessation interventions for pregnant smokers. The weight of the evidence from the general population of smokers suggests that nicotine replacement therapies may be beneficial cessation aids for pregnant smokers who are unable to stop smoking. The tremendous potential of these therapies for promoting smoking cessation among pregnant women creates a pressing need for decision tools and protocols to encourage treatment adherence that is essential for rigorous evaluation of the effectiveness of OTC NRT when provided as part of prenatal care. The results of this research could be directly translated to the improvement of obstetrical care providers' clinical practices. Medically supervised use of OTC NRT by pregnant smokers is an alternative to continued smoking that has the potential to substantially increase rates of smoking cessation during pregnancy.
OTC NCT00224419 Testing Pharmacological Therapies for Pregnant Smokers Terminated Duke University Phase 4 2003-06-01 Nicotine dependence has not been sufficiently addressed in current state-of-the-science cessation interventions for pregnant smokers. The weight of the evidence from the general population of smokers suggests that nicotine replacement therapies may be beneficial cessation aids for pregnant smokers who are unable to stop smoking. The tremendous potential of these therapies for promoting smoking cessation among pregnant women creates a pressing need for decision tools and protocols to encourage treatment adherence that is essential for rigorous evaluation of the effectiveness of OTC NRT when provided as part of prenatal care. The results of this research could be directly translated to the improvement of obstetrical care providers' clinical practices. Medically supervised use of OTC NRT by pregnant smokers is an alternative to continued smoking that has the potential to substantially increase rates of smoking cessation during pregnancy.
OTC NCT00405912 St. John's Wort for Tobacco Cessation Completed National Cancer Institute (NCI) Phase 2 2005-09-01 After a steady decline for the last 50 years, the prevalence of tobacco use in the United States has reached a plateau of approximately 23%. Currently available treatments among adults are expensive and not efficacious for all tobacco users. New pharmacologic agents need to be developed and tested to achieve the Healthy People 2010 goal of less than a 12% adult tobacco use prevalence. Bupropion, an FDA approved agent for tobacco cessation, acts by inhibiting central synaptosomal reuptake of dopamine and norepinephrine. A widely used herbal antidepressant, St. John's Wort (SJW), shares a similar mechanism of action and is effective for treating mild to moderate depression. SJW is well tolerated, available over the counter, and is significantly less expensive than the established treatments for tobacco dependence. To date, no prospective clinical trial evaluating the efficacy of SJW for the treatment of tobacco use has been published. We propose to evaluate the efficacy of SJW for increasing tobacco abstinence and decreasing nicotine withdrawal symptoms in a randomized, double-blind, placebo-controlled, three-arm, parallel group, dose-ranging clinical trial. Participants (N=120) will be randomly assigned to one of the three groups and will receive a twelve-week course of SJW 900 mg per day, 1800 mg per day, or a matching placebo. This study is anticipated to provide the data needed to develop a larger randomized controlled clinical trial submitted through the R01 funding mechanism.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Nicotine

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000284 Role of Metabolites in Nicotine Dependence (1) - 1 Completed University of Minnesota - Clinical and Translational Science Institute Phase 2 1995-02-01 The purpose of this study is to determine the effects of cotinine with or without a transdermal nicotine replacement on tobacco withdrawal symptoms.
NCT00000284 Role of Metabolites in Nicotine Dependence (1) - 1 Completed National Institute on Drug Abuse (NIDA) Phase 2 1995-02-01 The purpose of this study is to determine the effects of cotinine with or without a transdermal nicotine replacement on tobacco withdrawal symptoms.
NCT00000288 Role of Metabolites in Nicotine Dependence (2) - 5 Completed University of Minnesota - Clinical and Translational Science Institute Phase 2 1995-12-01 The purpose of this study is to determine the effects of varying doses of cotinine on cigarette self-administration.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Nicotine

Condition Name

Condition Name for Nicotine
Intervention Trials
Smoking Cessation 177
Nicotine Dependence 117
Smoking 104
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Condition MeSH

Condition MeSH for Nicotine
Intervention Trials
Tobacco Use Disorder 257
Schizophrenia 51
Disease 27
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Clinical Trial Locations for Nicotine

Trials by Country

Trials by Country for Nicotine
Location Trials
United States 816
Canada 48
Sweden 28
Germany 17
France 17
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Trials by US State

Trials by US State for Nicotine
Location Trials
California 77
Minnesota 57
Connecticut 55
Pennsylvania 54
Texas 51
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Clinical Trial Progress for Nicotine

Clinical Trial Phase

Clinical Trial Phase for Nicotine
Clinical Trial Phase Trials
Phase 4 149
Phase 3 79
Phase 2/Phase 3 26
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Clinical Trial Status

Clinical Trial Status for Nicotine
Clinical Trial Phase Trials
Completed 426
Recruiting 139
Not yet recruiting 96
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Clinical Trial Sponsors for Nicotine

Sponsor Name

Sponsor Name for Nicotine
Sponsor Trials
National Institute on Drug Abuse (NIDA) 168
National Cancer Institute (NCI) 59
Yale University 47
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Sponsor Type

Sponsor Type for Nicotine
Sponsor Trials
Other 848
NIH 316
Industry 181
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