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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01370356




Registration number
NCT01370356
Ethics application status
Date submitted
8/06/2011
Date registered
9/06/2011
Date last updated
1/09/2014

Titles & IDs
Public title
A Study To Evaluate The Efficacy And Safety Of Varenicline Compared To Placebo For Smoking Cessation Through Reduction
Scientific title
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
Secondary ID [1] 0 0
REDUCE TO QUIT
Secondary ID [2] 0 0
A3051075
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking Cessation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Varenicline Tartrate
Treatment: Drugs - Placebo

Active Comparator: Varenicline Tartrate -

Placebo Comparator: Placebo -


Treatment: Drugs: Varenicline Tartrate
Varenicline Tartrate oral tablets 2 (0.5mg) tablets twice a day for 24 weeks (first week titration)

Treatment: Drugs: Placebo
Matching placebo 2 oral tablets twice a day for 24 weeks (first week titration)

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking - 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).
Timepoint [1] 0 0
Week 15 - 24
Secondary outcome [1] 0 0
Percentage of Participants With CO Confirmed 4-Week CA From Smoking - 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).
Timepoint [1] 0 0
Week 21 - 24
Secondary outcome [2] 0 0
Percentage of Participants With CO Confirmed Long Term CA From Smoking - 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).
Timepoint [2] 0 0
Weeks 21 - 52
Secondary outcome [3] 0 0
Percentage of Participants With 7-Day Point Prevalence of Smoking Cessation - 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).
Timepoint [3] 0 0
Week 12, 24, and 52
Secondary outcome [4] 0 0
Percentage of Participants With 4-Week Point Prevalence of Smoking Cessation - 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).
Timepoint [4] 0 0
Week 52

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Health Services Research
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Australian Clinical Research Network - Maroubra
Recruitment hospital [2] 0 0
Brisbane South Clinical Research Centre - Carina Heights
Recruitment hospital [3] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [4] 0 0
Emeritus Research - Malvern
Recruitment postcode(s) [1] 0 0
2035 - Maroubra
Recruitment postcode(s) [2] 0 0
4152 - Carina Heights
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
3145 - Malvern
Recruitment outside Australia
Country [1] 0 0
United States of America
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California
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United States of America
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Florida
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Kentucky
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Minnesota
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Missouri
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Nebraska
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New Jersey
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United States of America
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New York
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United States of America
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Texas
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Canada
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British Columbia
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Canada
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Newfoundland and Labrador
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Canada
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Ontario
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Canada
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Quebec
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Czech Republic
State/province [14] 0 0
Brno
Country [15] 0 0
Czech Republic
State/province [15] 0 0
Liberec 1
Country [16] 0 0
Czech Republic
State/province [16] 0 0
Ostrava 1
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Czech Republic
State/province [17] 0 0
Praha 2
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Czech Republic
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Praha 6
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Egypt
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Alexandria
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Egypt
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Cairo
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Egypt
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El Fayoum
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Germany
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Berlin
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Germany
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Goettingen
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Germany
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Hamburg
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Germany
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Leipzig
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Germany
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Neuss
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Japan
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Kanagawa
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Japan
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Saitama
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Japan
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Tokyo
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Mexico
State/province [30] 0 0
D.f.
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Mexico
State/province [31] 0 0
Michoacan
Country [32] 0 0
Mexico
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Nuevo Leon
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Taiwan
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Taoyuan County
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
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United Kingdom
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Cornwall
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United Kingdom
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Devon
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United Kingdom
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Glasgow
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United Kingdom
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Llanelli
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United Kingdom
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Wilts
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United Kingdom
State/province [43] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01370356
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications