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

Completed · Phase 4 · Has a placebo group

Conditions studied: Smoking Cessation

In brief

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.

Key facts

Study ID

NCT01370356

Run by

Pfizer

People needed

1510

Starts

2011-07-01

Expected to finish

2013-07-01

Last updated by the study team

2014-09-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pharmacology Research Institute — Newport Beach, California, United States
• Clinical Neuroscience Solutions, Inc. — Jacksonville, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Orlando, Florida, United States
• Central Kentucky Research Associates, Inc. — Lexington, Kentucky, United States
• Mayo Clinic — Rochester, Minnesota, United States
• The Center for Pharmaceutical Research, P.C. — Kansas City, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• CRI Worldwide, LLC — Marlton, New Jersey, United States
• Clinical Research Integrity(CRI) Worldwide, LLC — Willingboro, New Jersey, United States
• Central New York Clinical Research — Manlius, New York, United States
• FutureSearch Clinical Trials, L.P. — Austin, Texas, United States
• Benchmark Research — Fort Worth, Texas, United States
• Healthfirst Medical Group — Fort Worth, Texas, United States
• Australian Clinical Research Network — Maroubra, New South Wales, Australia
• Brisbane South Clinical Research Centre — Carina Heights, Queensland, Australia
• Royal Brisbane and Women's Hospital — Herston, Queensland, Australia
• Emeritus Research — Malvern, Victoria, Australia
• Office of Dr. Ronald Collette — Burnaby, British Columbia, Canada
• James K. Lai, MD., Inc. — Vancouver, British Columbia, Canada
• White Hills Medical Clinic — St. John's, Newfoundland and Labrador, Canada
• Canadian Phase Onward Inc. — Toronto, Ontario, Canada
• Manna Research — Toronto, Ontario, Canada
• Clinique des Maladies Lipidiques de Quebec (CMLQ) — Québec, Quebec, Canada
• SurGal Clinic s.r.o. — Brno, Czechia
• Pharmacology Research Institute — Encino, California, United States

Full record on ClinicalTrials.gov

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