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Last Updated: June 6, 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.
OTC NCT00405912 St. John's Wort for Tobacco Cessation Completed Mayo Clinic 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.
OTC NCT00722124 S-Adenosyl-L-Methionine (SAMe) for Smoking Abstinence Completed Pharmavite Phase 2/Phase 3 2008-09-01 Cigarette smoking is of great public health importance and is the single most important preventable cause of morbidity, mortality and excess health care costs in the United States. After a steady decline for the last 50 years, the prevalence of tobacco use in the United States has reached a plateau of approximately 21%. Currently available treatments among adults are not efficacious for all tobacco users. New pharmacologic agents thus need to be continually developed and tested. The release of dopamine in the nucleus accumbens is one of the key components of the pleasurable and rewarding effects of nicotine. Drugs that increase monoamine neurotransmitter availability (particularly dopamine and norepinephrine) are likely to increase the reward function and thus ameliorate withdrawal symptoms. S-Adenosyl-L-Methionine (SAMe), the primary methyl donor for the central nervous system (CNS), donates methyl groups towards presynaptic synthesis of CNS monoamine neurotransmitters. By facilitating the synthesis of dopamine and norepinephrine in the brain, SAMe is likely to ameliorate the symptoms of nicotine withdrawal, thus improving tobacco abstinence rates in smokers who are trying to stop smoking. SAMe is well tolerated and is available over-the-counter. To date, no prospective clinical trial evaluating the efficacy of SAMe for the treatment of tobacco dependence has been published. We propose to evaluate the efficacy of SAMe for increasing smoking abstinence and decreasing nicotine withdrawal symptoms in a randomized, blinded, placebo-controlled, three-arm, parallel-group, dose-ranging phase II clinical trial. Participants (N=120) will be randomly assigned to one of the three groups, and will receive an 8-week course of SAMe 800-mg per day, 1600-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, if the results appear promising.
OTC NCT00722124 S-Adenosyl-L-Methionine (SAMe) for Smoking Abstinence Completed Mayo Clinic Phase 2/Phase 3 2008-09-01 Cigarette smoking is of great public health importance and is the single most important preventable cause of morbidity, mortality and excess health care costs in the United States. After a steady decline for the last 50 years, the prevalence of tobacco use in the United States has reached a plateau of approximately 21%. Currently available treatments among adults are not efficacious for all tobacco users. New pharmacologic agents thus need to be continually developed and tested. The release of dopamine in the nucleus accumbens is one of the key components of the pleasurable and rewarding effects of nicotine. Drugs that increase monoamine neurotransmitter availability (particularly dopamine and norepinephrine) are likely to increase the reward function and thus ameliorate withdrawal symptoms. S-Adenosyl-L-Methionine (SAMe), the primary methyl donor for the central nervous system (CNS), donates methyl groups towards presynaptic synthesis of CNS monoamine neurotransmitters. By facilitating the synthesis of dopamine and norepinephrine in the brain, SAMe is likely to ameliorate the symptoms of nicotine withdrawal, thus improving tobacco abstinence rates in smokers who are trying to stop smoking. SAMe is well tolerated and is available over-the-counter. To date, no prospective clinical trial evaluating the efficacy of SAMe for the treatment of tobacco dependence has been published. We propose to evaluate the efficacy of SAMe for increasing smoking abstinence and decreasing nicotine withdrawal symptoms in a randomized, blinded, placebo-controlled, three-arm, parallel-group, dose-ranging phase II clinical trial. Participants (N=120) will be randomly assigned to one of the three groups, and will receive an 8-week course of SAMe 800-mg per day, 1600-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, if the results appear promising.
OTC NCT01537471 The Effects of Antihistamines on Pre-Pulse Inhibition Completed Wallace H. Coulter Foundation Phase 1 2012-01-01 The purpose of the investigators research is to test whether problems people have with processing their senses (feeling overwhelmed, distracted or upset by sounds and other stimuli) can be lessened by meclizine, a drug found in many over the counter antihistamines, which are medicines used for things like allergies, sleep problems, or the common cold.
>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.
NCT00000288 Role of Metabolites in Nicotine Dependence (2) - 5 Completed National Institute on Drug Abuse (NIDA) Phase 2 1995-12-01 The purpose of this study is to determine the effects of varying doses of cotinine on cigarette self-administration.
NCT00000289 Role of Metabolites in Nicotine Dependence (3) - 6 Completed University of Minnesota - Clinical and Translational Science Institute Phase 2 1998-05-01 The purpose of this study is to determine the effects of various doses of ondansetron transdermal nicotine replacement on tobacco withdrawal symptoms.
NCT00000289 Role of Metabolites in Nicotine Dependence (3) - 6 Completed National Institute on Drug Abuse (NIDA) Phase 2 1998-05-01 The purpose of this study is to determine the effects of various doses of ondansetron transdermal nicotine replacement on tobacco withdrawal symptoms.
NCT00000295 Progesterone Treatment in Female Smokers - 12 Completed University of Minnesota - Clinical and Translational Science Institute Phase 2 1999-04-01 The purpose of this study is to investigate progesterone effects in female smokers
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Nicotine

Condition Name

Condition Name for Nicotine
Intervention Trials
Smoking Cessation 179
Nicotine Dependence 118
Smoking 104
Tobacco Use Disorder 86
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Condition MeSH

Condition MeSH for Nicotine
Intervention Trials
Tobacco Use Disorder 258
Schizophrenia 51
Alcoholism 27
Disease 27
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Clinical Trial Locations for Nicotine

Trials by Country

Trials by Country for Nicotine
Location Trials
United States 821
Canada 49
Sweden 28
Germany 17
France 17
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Trials by US State

Trials by US State for Nicotine
Location Trials
California 78
Minnesota 58
Connecticut 55
Pennsylvania 54
Texas 52
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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 142
Not yet recruiting 101
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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) 60
Yale University 49
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Sponsor Type

Sponsor Type for Nicotine
Sponsor Trials
Other 856
NIH 318
Industry 181
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Serving leading biopharmaceutical companies globally:

Mallinckrodt
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Harvard Business School
AstraZeneca
Johnson and Johnson

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