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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pharmacology Research Institute
Encino, California, 91316 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Smoking Cessation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01370356
Pfizer
Completed
A Study To Evaluate The Efficacy And Safety Of Varenicline Compared To Placebo For Smoking Cessation Through Reduction

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A Study To Evaluate The Efficacy And Safety Of Varenicline Compared To Placebo For Smoking Cessation Through Reduction
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Smoking Cessation
  • Drug: Varenicline Tartrate
    Varenicline Tartrate oral tablets 2 (0.5mg) tablets twice a day for 24 weeks (first week titration)
  • Drug: Placebo
    Matching placebo 2 oral tablets twice a day for 24 weeks (first week titration)
  • Active Comparator: Varenicline Tartrate
    Intervention: Drug: Varenicline Tartrate
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Ebbert JO, Hughes JR, West RJ, Rennard SI, Russ C, McRae TD, Treadow J, Yu CR, Dutro MP, Park PW. Effect of varenicline on smoking cessation through smoking reduction: a randomized clinical trial. JAMA. 2015 Feb 17;313(7):687-94. doi: 10.1001/jama.2015.280.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1510
July 2013
July 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   Czech Republic,   Egypt,   Germany,   Japan,   Mexico,   Taiwan,   United Kingdom,   United States
 
 
NCT01370356
A3051075
REDUCE TO QUIT
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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