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Last Updated: June 26, 2022

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.
NCT00492349 ↗ Varenicline Adjunctive Treatment in Schizophrenia Completed Stanley Medical Research Institute Phase 4 2007-05-01 The principal aim of the project is to conduct an off-label adjunctive clinical trial evaluating varenicline as a treatment for core neurobiological and clinical deficits in schizophrenia, in addition to evaluating for smoking cessation in schizophrenia patients.
NCT00492349 ↗ Varenicline Adjunctive Treatment in Schizophrenia Completed University of Maryland Phase 4 2007-05-01 The principal aim of the project is to conduct an off-label adjunctive clinical trial evaluating varenicline as a treatment for core neurobiological and clinical deficits in schizophrenia, in addition to evaluating for smoking cessation in schizophrenia patients.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Chantix

Condition Name

Condition Name for Chantix
Intervention Trials
Smoking Cessation 42
Nicotine Dependence 38
Smoking 20
Tobacco Use Disorder 15
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Condition MeSH

Condition MeSH for Chantix
Intervention Trials
Tobacco Use Disorder 62
Alcoholism 14
Schizophrenia 11
Disease 9
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Clinical Trial Locations for Chantix

Trials by Country

Trials by Country for Chantix
Location Trials
United States 164
Canada 7
Israel 3
Netherlands 2
United Kingdom 2
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Trials by US State

Trials by US State for Chantix
Location Trials
Pennsylvania 21
Minnesota 16
Connecticut 15
New York 15
North Carolina 12
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Clinical Trial Progress for Chantix

Clinical Trial Phase

Clinical Trial Phase for Chantix
Clinical Trial Phase Trials
Phase 4 42
Phase 3 19
Phase 2/Phase 3 11
[disabled in preview] 48
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Clinical Trial Status

Clinical Trial Status for Chantix
Clinical Trial Phase Trials
Completed 114
Recruiting 13
Withdrawn 10
[disabled in preview] 17
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Clinical Trial Sponsors for Chantix

Sponsor Name

Sponsor Name for Chantix
Sponsor Trials
National Institute on Drug Abuse (NIDA) 45
Pfizer 33
University of Pennsylvania 16
[disabled in preview] 29
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Sponsor Type

Sponsor Type for Chantix
Sponsor Trials
Other 206
NIH 86
Industry 43
[disabled in preview] 14
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