Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01370356
Recruitment Status : Completed
First Posted : June 9, 2011
Results First Posted : September 1, 2014
Last Update Posted : September 1, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE June 8, 2011
First Posted Date  ICMJE June 9, 2011
Results First Submitted Date  ICMJE July 2, 2014
Results First Posted Date  ICMJE September 1, 2014
Last Update Posted Date September 1, 2014
Study Start Date  ICMJE July 2011
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2014)
Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking [ Time Frame: Week 15 - 24 ]
Percentage of participants who remained abstinent from Week 15 to Week 24, inclusive, reporting no smoking and no use of nicotine-containing products since the last study visit or contact on the Nicotine Use Inventory (NUI) and confirmed by expired CO < 10 ppm at any time point (CO measurements conducted at the clinic visits) during Weeks 15 through 24, inclusive. Missing CO was imputed as negative (CO ≤ 10 ppm).
Original Primary Outcome Measures  ICMJE
 (submitted: June 8, 2011)
Carbon Monoxide (CO) confirmed Continuous Abstinence (CA) during the last 10 weeks of treatment Weeks 15-24 [ Time Frame: Weeks 15-24 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2014)
  • Percentage of Participants With CO Confirmed 4-Week CA From Smoking [ Time Frame: Week 21 - 24 ]
    Percentage of participants who remained abstinent from Week 21 to Week 24, inclusive, reporting no smoking and no use of nicotine-containing products since the last study visit or contact on the NUI and confirmed by expired CO < 10 ppm at any time point (CO measurements conducted at the clinic visits) during Weeks 21 through 24, inclusive. Missing CO was imputed as negative (CO ≤ 10 ppm).
  • Percentage of Participants With CO Confirmed Long Term CA From Smoking [ Time Frame: Weeks 21 - 52 ]
    Percentage of participants who remained abstinent from Week 21 to Week 52, inclusive, reporting no smoking and no use of nicotine-containing products since the last study visit or contact on the NUI and confirmed by expired CO < 10 ppm at any time point (CO measurements conducted at the clinic visits) during Weeks 21 through 52, inclusive. Missing CO was imputed as negative (CO ≤ 10 ppm).
  • Percentage of Participants With 7-Day Point Prevalence of Smoking Cessation [ Time Frame: Week 12, 24, and 52 ]
    The 7-day point prevalence of abstinence was defined as being abstinent from smoking and using tobacco products during the last 7 days at Week 12, 24, and 52. The participant's smoking status and other nicotine use was evaluated based on the "last 7 days" questions on the NUI and confirmed by CO expiration. Responders were defined as those, who answered "no" to both questions ("Has the subject smoked any cigarettes (even a puff) in the last 7 days?"; and "Has the subject used any nicotine products and/or other tobacco.... in the last 7 days?") and whose expired CO < 10 ppm. Missing CO was imputed as negative (CO ≤ 10 ppm).
  • Percentage of Participants With 4-Week Point Prevalence of Smoking Cessation [ Time Frame: Week 52 ]
    The 4-week point prevalence of abstinence was defined as being abstinent from smoking and using tobacco products during the last 4 weeks of the study. The participant's smoking status and other nicotine use was evaluated based on the "last 4 weeks" questions on the NUI and confirmed by CO expiration. Responders were defined as those, who answered "no" to both questions ("Has the subject smoked any cigarettes (even a puff) in the last 4 weeks?"; and "Has the subject used any nicotine products and/or other tobacco.... in the last 4 weeks?") and whose expired CO < 10 ppm. Missing CO was imputed as negative (CO ≤ 10 ppm).
Original Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2011)
  • Carbon Monoxide (CO) confirmed Continuous Abstinence (CA) Weeks 21-24 [ Time Frame: Weeks 21-24 ]
  • Carbon Monoxide (CO) confirmed Continuous Abstinence (CA) Weeks 21-52 [ Time Frame: Weeks 21-52 ]
  • 7 day point prevalence of smoking cessation at Weeks 12, 24, and 52 [ Time Frame: Week 12, 24, and 52 ]
  • 4 week point prevalence of smoking cessation at Week 52 [ Time Frame: Week 52 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study To Evaluate The Efficacy And Safety Of Varenicline Compared To Placebo For Smoking Cessation Through Reduction
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Condition  ICMJE Smoking Cessation
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • Active Comparator: Varenicline Tartrate
    Intervention: Drug: Varenicline Tartrate
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 29, 2014)
1510
Original Estimated Enrollment  ICMJE
 (submitted: June 8, 2011)
1404
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Czech Republic,   Egypt,   Germany,   Japan,   Mexico,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01370356
Other Study ID Numbers  ICMJE A3051075
REDUCE TO QUIT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP