A Study To Evaluate The Efficacy And Safety Of Varenicline Compared To Placebo For Smoking Cessation Through Reduction.



Status:Completed
Conditions:Smoking Cessation
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:July 2011
End Date:June 2013
Contact:Pfizer CT.gov Call Center
Phone:1-800-718-1021

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A Phase 4, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of Varenicline Compared To Placebo For Smoking Cessation Through Reduction


This study will determine whether varenicline is safe and helps people to quit smoking
through reduction when they are not willing/able to make an abrupt quit attempt.


Inclusion Criteria:

- Male and female cigarette smokers over the age of 18 years who are not willing/able
to quit smoking within the next month but who are willing to attempt to reduce their
smoking to work toward a quit attempt within the next 3 months.

- Subjects must have smoked an average of at least 10 cigarettes per day during the
past year and during the month prior to the screening visit, with no continuous
period of abstinence greater than 3 months in the past year and who have an exhaled
carbon monoxide (CO) >10 ppm at screening.

- Subjects with mild to moderate depression or anxiety may be included if their
condition is stable.

Exclusion Criteria:

- Subjects with a history of a suicide attempt or any suicidal behavior in the past two
years.

- Subjects with severe depression or anxiety.

- Subjects with psychosis, panic disorder, bipolar disorder, post traumatic stress
disorder (PTSD), or schizophrenia.

- Subjects with alcohol or substance abuse or dependence (except nicotine) unless in
full remission for at least 12 months.
We found this trial at
12
sites
Fort Worth, Texas 76135
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Austin, TX
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Jacksonville, Florida 32216
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Jacksonville, FL
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Kansas City, Missouri 64114
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Kansas City, MO
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Lexington, Kentucky 40509
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Lexington, KY
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Manlius, New York 13104
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Manlius, NY
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Newport Beach, California 92660
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Newport Beach, CA
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Omaha, NE
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Rochester, MN
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San Angelo, Texas 76904
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San Angelo, TX
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Willingboro, New Jersey 08046
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Willingboro, NJ
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Willingboro, New Jersey 08046
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Willingboro, NJ
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