CLINICAL TRIALS PROFILE FOR CHANTIX

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.

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.

Clinical Trial Conditions for CHANTIX

Condition Name

Condition Name for CHANTIX
Intervention	Trials
Smoking Cessation	44
Nicotine Dependence	38
Smoking	20
Tobacco Use Disorder	15

Condition MeSH

Condition MeSH for CHANTIX
Intervention	Trials
Tobacco Use Disorder	62
Alcoholism	14
Schizophrenia	11
Disease	9

Clinical Trial Locations for CHANTIX

Trials by Country

Trials by Country for CHANTIX
Location	Trials
United States	166
Canada	7
Israel	3
Netherlands	2
United Kingdom	2

Trials by US State

Trials by US State for CHANTIX
Location	Trials
Pennsylvania	21
Minnesota	16
New York	15
Connecticut	15
North Carolina	13

Clinical Trial Progress for CHANTIX

Clinical Trial Phase

Clinical Trial Phase for CHANTIX
Clinical Trial Phase	Trials
Phase 4	43
Phase 3	20
Phase 2/Phase 3	11

Clinical Trial Status

Clinical Trial Status for CHANTIX
Clinical Trial Phase	Trials
Completed	114
Recruiting	13
Withdrawn	10

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

Sponsor Type

Sponsor Type for CHANTIX
Sponsor	Trials
Other	208
NIH	87
Industry	43