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 |
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
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Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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