Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
Query!
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
Query!
Secondary ID [1]
0
0
REDUCE TO QUIT
Query!
Secondary ID [2]
0
0
A3051075
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Smoking Cessation
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
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)
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking
Query!
Assessment method [1]
0
0
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).
Query!
Timepoint [1]
0
0
Week 15 - 24
Query!
Secondary outcome [1]
0
0
Percentage of Participants With CO Confirmed 4-Week CA From Smoking
Query!
Assessment method [1]
0
0
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).
Query!
Timepoint [1]
0
0
Week 21 - 24
Query!
Secondary outcome [2]
0
0
Percentage of Participants With CO Confirmed Long Term CA From Smoking
Query!
Assessment method [2]
0
0
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).
Query!
Timepoint [2]
0
0
Weeks 21 - 52
Query!
Secondary outcome [3]
0
0
Percentage of Participants With 7-Day Point Prevalence of Smoking Cessation
Query!
Assessment method [3]
0
0
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).
Query!
Timepoint [3]
0
0
Week 12, 24, and 52
Query!
Secondary outcome [4]
0
0
Percentage of Participants With 4-Week Point Prevalence of Smoking Cessation
Query!
Assessment method [4]
0
0
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).
Query!
Timepoint [4]
0
0
Week 52
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Other
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 4
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/07/2011
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/07/2013
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1510
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Query!
Recruitment hospital [1]
0
0
Australian Clinical Research Network - Maroubra
Query!
Recruitment hospital [2]
0
0
Brisbane South Clinical Research Centre - Carina Heights
Query!
Recruitment hospital [3]
0
0
Royal Brisbane and Women's Hospital - Herston
Query!
Recruitment hospital [4]
0
0
Emeritus Research - Malvern
Query!
Recruitment postcode(s) [1]
0
0
2035 - Maroubra
Query!
Recruitment postcode(s) [2]
0
0
4152 - Carina Heights
Query!
Recruitment postcode(s) [3]
0
0
4029 - Herston
Query!
Recruitment postcode(s) [4]
0
0
3145 - Malvern
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Florida
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Kentucky
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Minnesota
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Missouri
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Nebraska
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
New Jersey
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
New York
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Texas
Query!
Country [10]
0
0
Canada
Query!
State/province [10]
0
0
British Columbia
Query!
Country [11]
0
0
Canada
Query!
State/province [11]
0
0
Newfoundland and Labrador
Query!
Country [12]
0
0
Canada
Query!
State/province [12]
0
0
Ontario
Query!
Country [13]
0
0
Canada
Query!
State/province [13]
0
0
Quebec
Query!
Country [14]
0
0
Czech Republic
Query!
State/province [14]
0
0
Brno
Query!
Country [15]
0
0
Czech Republic
Query!
State/province [15]
0
0
Liberec 1
Query!
Country [16]
0
0
Czech Republic
Query!
State/province [16]
0
0
Ostrava 1
Query!
Country [17]
0
0
Czech Republic
Query!
State/province [17]
0
0
Praha 2
Query!
Country [18]
0
0
Czech Republic
Query!
State/province [18]
0
0
Praha 6
Query!
Country [19]
0
0
Egypt
Query!
State/province [19]
0
0
Alexandria
Query!
Country [20]
0
0
Egypt
Query!
State/province [20]
0
0
Cairo
Query!
Country [21]
0
0
Egypt
Query!
State/province [21]
0
0
El Fayoum
Query!
Country [22]
0
0
Germany
Query!
State/province [22]
0
0
Berlin
Query!
Country [23]
0
0
Germany
Query!
State/province [23]
0
0
Goettingen
Query!
Country [24]
0
0
Germany
Query!
State/province [24]
0
0
Hamburg
Query!
Country [25]
0
0
Germany
Query!
State/province [25]
0
0
Leipzig
Query!
Country [26]
0
0
Germany
Query!
State/province [26]
0
0
Neuss
Query!
Country [27]
0
0
Japan
Query!
State/province [27]
0
0
Kanagawa
Query!
Country [28]
0
0
Japan
Query!
State/province [28]
0
0
Saitama
Query!
Country [29]
0
0
Japan
Query!
State/province [29]
0
0
Tokyo
Query!
Country [30]
0
0
Mexico
Query!
State/province [30]
0
0
D.f.
Query!
Country [31]
0
0
Mexico
Query!
State/province [31]
0
0
Michoacan
Query!
Country [32]
0
0
Mexico
Query!
State/province [32]
0
0
Nuevo Leon
Query!
Country [33]
0
0
Taiwan
Query!
State/province [33]
0
0
Taoyuan County
Query!
Country [34]
0
0
Taiwan
Query!
State/province [34]
0
0
Kaohsiung
Query!
Country [35]
0
0
Taiwan
Query!
State/province [35]
0
0
Taichung
Query!
Country [36]
0
0
Taiwan
Query!
State/province [36]
0
0
Tainan
Query!
Country [37]
0
0
Taiwan
Query!
State/province [37]
0
0
Taipei
Query!
Country [38]
0
0
United Kingdom
Query!
State/province [38]
0
0
Cornwall
Query!
Country [39]
0
0
United Kingdom
Query!
State/province [39]
0
0
Devon
Query!
Country [40]
0
0
United Kingdom
Query!
State/province [40]
0
0
Glasgow
Query!
Country [41]
0
0
United Kingdom
Query!
State/province [41]
0
0
Llanelli
Query!
Country [42]
0
0
United Kingdom
Query!
State/province [42]
0
0
Wilts
Query!
Country [43]
0
0
United Kingdom
Query!
State/province [43]
0
0
London
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Pfizer
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT01370356
Query!
Trial related presentations / publications
Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4. Nakamura M, Abe M, Ohkura M, Treadow J, Yu CR, Park PW. Efficacy of Varenicline for Cigarette Reduction Before Quitting in Japanese Smokers: A Subpopulation Analysis of the Reduce to Quit Trial. Clin Ther. 2017 Apr;39(4):863-872. doi: 10.1016/j.clinthera.2017.03.007. Epub 2017 Mar 30. 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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
Query!
Address
0
0
Pfizer
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01370356
Download to PDF