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Last Updated: May 16, 2021

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CLINICAL TRIALS PROFILE FOR CHANTIX

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505(b)(2) Clinical Trials for Chantix

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 NCT03557294 Varenicline OTC Trial on Efficacy and Safety Recruiting Los Angeles Clinical Trials Phase 4 2018-05-07 The primary goal of the proposed research is to test whether varenicline (Chantix) is safe and effective as an over-the-counter (OTC) medication.
OTC NCT03557294 Varenicline OTC Trial on Efficacy and Safety Recruiting National Institute on Drug Abuse (NIDA) Phase 4 2018-05-07 The primary goal of the proposed research is to test whether varenicline (Chantix) is safe and effective as an over-the-counter (OTC) medication.
OTC NCT03557294 Varenicline OTC Trial on Efficacy and Safety Recruiting Pfizer Phase 4 2018-05-07 The primary goal of the proposed research is to test whether varenicline (Chantix) is safe and effective as an over-the-counter (OTC) medication.
OTC NCT03557294 Varenicline OTC Trial on Efficacy and Safety Recruiting University of Nevada, Reno Phase 4 2018-05-07 The primary goal of the proposed research is to test whether varenicline (Chantix) is safe and effective as an over-the-counter (OTC) medication.
OTC NCT03557294 Varenicline OTC Trial on Efficacy and Safety Recruiting Arizona State University Phase 4 2018-05-07 The primary goal of the proposed research is to test whether varenicline (Chantix) is safe and effective as an over-the-counter (OTC) medication.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Chantix

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00455650 Study of the Effects of Mecamylamine and Varenicline in Schizophrenia Completed National Alliance for Research on Schizophrenia and Depression N/A 2007-03-01 We are conducting this study to find out if blocking or partially stimulating the effects of nicotine in the brain can affect memory and concentration. Nicotine is the addictive drug found in tobacco products. Our subjects will be people with and without mental illness (schizophrenia), smokers and non-smokers. We will use a medication called mecamylamine (Inversine) to block the effects of nicotine on the brains of our subjects. We will also use a medication called varenicline (Chantix) to partially increase the effects of nicotine on the brains of our subjects. This study also uses a placebo, a pill that does not have any active ingredients but looks exactly like the mecamylamine and varenicline pills. We will compare the effects of giving mecamylamine or placebo to people who have schizophrenia and people who do not have schizophrenia. We know that people with schizophrenia smoke heavily and find it harder to stop smoking than most other people do. Studies have shown that people with schizophrenia may smoke more because nicotine helps their concentration and memory. We are interested in helping people with schizophrenia smoke less. Mecamylamine blocks the parts of the brain that react to nicotine and varenicline partially stimulates and partially blocks the parts of the brain that react to nicotine. Both medications may decrease the effects that smoking has on the body.
NCT00455650 Study of the Effects of Mecamylamine and Varenicline in Schizophrenia Completed The Bowman Family Foundation N/A 2007-03-01 We are conducting this study to find out if blocking or partially stimulating the effects of nicotine in the brain can affect memory and concentration. Nicotine is the addictive drug found in tobacco products. Our subjects will be people with and without mental illness (schizophrenia), smokers and non-smokers. We will use a medication called mecamylamine (Inversine) to block the effects of nicotine on the brains of our subjects. We will also use a medication called varenicline (Chantix) to partially increase the effects of nicotine on the brains of our subjects. This study also uses a placebo, a pill that does not have any active ingredients but looks exactly like the mecamylamine and varenicline pills. We will compare the effects of giving mecamylamine or placebo to people who have schizophrenia and people who do not have schizophrenia. We know that people with schizophrenia smoke heavily and find it harder to stop smoking than most other people do. Studies have shown that people with schizophrenia may smoke more because nicotine helps their concentration and memory. We are interested in helping people with schizophrenia smoke less. Mecamylamine blocks the parts of the brain that react to nicotine and varenicline partially stimulates and partially blocks the parts of the brain that react to nicotine. Both medications may decrease the effects that smoking has on the body.
NCT00455650 Study of the Effects of Mecamylamine and Varenicline in Schizophrenia Completed Massachusetts General Hospital N/A 2007-03-01 We are conducting this study to find out if blocking or partially stimulating the effects of nicotine in the brain can affect memory and concentration. Nicotine is the addictive drug found in tobacco products. Our subjects will be people with and without mental illness (schizophrenia), smokers and non-smokers. We will use a medication called mecamylamine (Inversine) to block the effects of nicotine on the brains of our subjects. We will also use a medication called varenicline (Chantix) to partially increase the effects of nicotine on the brains of our subjects. This study also uses a placebo, a pill that does not have any active ingredients but looks exactly like the mecamylamine and varenicline pills. We will compare the effects of giving mecamylamine or placebo to people who have schizophrenia and people who do not have schizophrenia. We know that people with schizophrenia smoke heavily and find it harder to stop smoking than most other people do. Studies have shown that people with schizophrenia may smoke more because nicotine helps their concentration and memory. We are interested in helping people with schizophrenia smoke less. Mecamylamine blocks the parts of the brain that react to nicotine and varenicline partially stimulates and partially blocks the parts of the brain that react to nicotine. Both medications may decrease the effects that smoking has on the body.
NCT00502216 Naltrexone and Varenicline: Weight Gain and Tolerability in Cigarette Smokers Completed National Institute on Alcohol Abuse and Alcoholism (NIAAA) Phase 1/Phase 2 2007-07-01 The purpose of this study is to determine whether the combination of naltrexone (Depade) and varenicline (Chantix) minimizes post-smoking cessation weight gain and how well the combination is tolerated.
NCT00502216 Naltrexone and Varenicline: Weight Gain and Tolerability in Cigarette Smokers Completed National Institute on Drug Abuse (NIDA) Phase 1/Phase 2 2007-07-01 The purpose of this study is to determine whether the combination of naltrexone (Depade) and varenicline (Chantix) minimizes post-smoking cessation weight gain and how well the combination is tolerated.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Chantix

Condition Name

Condition Name for Chantix
Intervention Trials
Smoking Cessation 27
Nicotine Dependence 16
Smoking 12
Tobacco Dependence 7
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Condition MeSH

Condition MeSH for Chantix
Intervention Trials
Tobacco Use Disorder 27
Alcohol Drinking 5
Disease 5
Substance-Related Disorders 4
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Clinical Trial Locations for Chantix

Trials by Country

Trials by Country for Chantix
Location Trials
United States 77
Canada 2
United Kingdom 2
Lebanon 1
Sweden 1
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Trials by US State

Trials by US State for Chantix
Location Trials
North Carolina 8
Pennsylvania 8
Connecticut 6
California 6
Minnesota 5
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Clinical Trial Progress for Chantix

Clinical Trial Phase

Clinical Trial Phase for Chantix
Clinical Trial Phase Trials
Phase 4 24
Phase 3 11
Phase 2/Phase 3 6
[disabled in preview] 23
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Clinical Trial Status

Clinical Trial Status for Chantix
Clinical Trial Phase Trials
Completed 34
Not yet recruiting 20
Recruiting 11
[disabled in preview] 12
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Clinical Trial Sponsors for Chantix

Sponsor Name

Sponsor Name for Chantix
Sponsor Trials
Pfizer 21
National Institute on Drug Abuse (NIDA) 19
National Cancer Institute (NCI) 7
[disabled in preview] 13
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Sponsor Type

Sponsor Type for Chantix
Sponsor Trials
Other 98
NIH 38
Industry 29
[disabled in preview] 3
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