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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
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
Timepoint [1] 0 0
Week 15 - 24
Secondary outcome [1] 0 0
Percentage of Participants With CO Confirmed 4-Week CA From Smoking
Timepoint [1] 0 0
Week 21 - 24
Secondary outcome [2] 0 0
Percentage of Participants With CO Confirmed Long Term CA From Smoking
Timepoint [2] 0 0
Weeks 21 - 52
Secondary outcome [3] 0 0
Percentage of Participants With 7-Day Point Prevalence of Smoking Cessation
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
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
Sex
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
Other
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
1/07/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2013
Sample size
Target
Accrual to date
Final
1510
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
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Kentucky
Country [4] 0 0
United States of America
State/province [4] 0 0
Minnesota
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
Nebraska
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
Canada
State/province [10] 0 0
British Columbia
Country [11] 0 0
Canada
State/province [11] 0 0
Newfoundland and Labrador
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
Canada
State/province [13] 0 0
Quebec
Country [14] 0 0
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
Country [17] 0 0
Czech Republic
State/province [17] 0 0
Praha 2
Country [18] 0 0
Czech Republic
State/province [18] 0 0
Praha 6
Country [19] 0 0
Egypt
State/province [19] 0 0
Alexandria
Country [20] 0 0
Egypt
State/province [20] 0 0
Cairo
Country [21] 0 0
Egypt
State/province [21] 0 0
El Fayoum
Country [22] 0 0
Germany
State/province [22] 0 0
Berlin
Country [23] 0 0
Germany
State/province [23] 0 0
Goettingen
Country [24] 0 0
Germany
State/province [24] 0 0
Hamburg
Country [25] 0 0
Germany
State/province [25] 0 0
Leipzig
Country [26] 0 0
Germany
State/province [26] 0 0
Neuss
Country [27] 0 0
Japan
State/province [27] 0 0
Kanagawa
Country [28] 0 0
Japan
State/province [28] 0 0
Saitama
Country [29] 0 0
Japan
State/province [29] 0 0
Tokyo
Country [30] 0 0
Mexico
State/province [30] 0 0
D.f.
Country [31] 0 0
Mexico
State/province [31] 0 0
Michoacan
Country [32] 0 0
Mexico
State/province [32] 0 0
Nuevo Leon
Country [33] 0 0
Taiwan
State/province [33] 0 0
Taoyuan County
Country [34] 0 0
Taiwan
State/province [34] 0 0
Kaohsiung
Country [35] 0 0
Taiwan
State/province [35] 0 0
Taichung
Country [36] 0 0
Taiwan
State/province [36] 0 0
Tainan
Country [37] 0 0
Taiwan
State/province [37] 0 0
Taipei
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Cornwall
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Devon
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Glasgow
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Llanelli
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Wilts
Country [43] 0 0
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/study/NCT01370356
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.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01370356