Smoking CessationPhase 4NCT01370356

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

A Phase 4 study testing Varenicline Tartrate in people with Smoking Cessation, run by Pfizer at 65 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Smoking Cessation
What is being tested?: Varenicline Tartrate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,510 participants
Where: 65 sitesin 10 countries
Study dates: Jul 2011to Jul 2013
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

65 sites in 10 countries.

Country

City, postcode or hospital

65 sites in 10 countries

United States14 sites

FutureSearch Clinical Trials, L.P.
Austin, Texas, 78731
Pharmacology Research Institute
Encino, California, 91316
Benchmark Research
Fort Worth, Texas, 76135
Healthfirst Medical Group
Fort Worth, Texas, 76135
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32216
The Center for Pharmaceutical Research, P.C.
Kansas City, Missouri, 64114
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, 40509
Central New York Clinical Research
Manlius, New York, 13104
CRI Worldwide, LLC
Marlton, New Jersey, 08053
Pharmacology Research Institute
Newport Beach, California, 92660
University of Nebraska Medical Center
Omaha, Nebraska, 68198-5910
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32806
Mayo Clinic
Rochester, Minnesota, 55905
Clinical Research Integrity(CRI) Worldwide, LLC
Willingboro, New Jersey, 08046

Other trials in United States

Czechia7 sites

SurGal Clinic s.r.o.
Brno, 602 00
Fakultni nemocnice u sv. Anny v Brne
Brno, 656 91
Krajska nemocnice Liberec a.s., Plicni oddeleni
Liberec, 460 01
Mestska nemocnice Ostrava, Plicni oddeleni
Ostrava, 728 80
Vseobecna fakultni nemocnice v Praze, III. interni klinika
Prague, 120 00
Vseobecna fakultni nemocnice v Praze
Prague, 120 00
Ustredni vojenska nemocnice Praha
Prague, 169 02

Other trials in Czechia

Germany7 sites

Klinische Forschung Berlin
Berlin, 10787
Klinische Forschung Berlin-Buch GmbH
Berlin, 13125
Universitaetsklinikum Goettingen Zentrum Innere Medizin Abteilung Kardiologie und Pneumologie
Göttingen, 37075
Universitaetsklinikum Goettingen, Zentrum Innere Medizin, Abteilung Kardiologie und Pneumologie
Göttingen, 37075
Klinische Forschung Hamburg GmbH
Hamburg, 20253
Medamed- Studienambulanz
Leipzig, 04109
FOCUS Clinical Drug Development GmbH
Neuss, 41460

Other trials in Germany

Taiwan7 sites

Kaohsiung Veterans General Hosptial
Kaohsiung City, 813
Chang Gung Medical Foundation-Linkou Branch
Kweishan Town, Taoyuan County, 333
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
China Medical University Hospital
Taichung, 404
National Cheng Kung University Hospital
Tainan, 704
National Taiwan University Hospital, Department of Family Medicine
Taipei, 100
Taipei Veterans General Hospital
Taipei, 112

Other trials in Taiwan

United Kingdom7 sites

Castlemilk Health Centre
Castlemilk, Glasgow, G45 9EW
Hathaway Medical Centre
Chippenham, Wilts, SN14 8GT
Prince Philip Hospital
Dafen, Llanelli, SA14 8QF
Enchord Limited
Fowey, Cornwall, PL23 1DT
The Jenner Practice
London, SE23 1HU
The Alverton Practice
Penzance, Cornwall, TR18 4JH
Knowle House Surgery
Plymouth, Devon, PL5 3JB

Other trials in United Kingdom

Canada6 sites

Office of Dr. Ronald Collette
Burnaby, British Columbia, V5G 1T4
Clinique des Maladies Lipidiques de Quebec (CMLQ)
Québec, Quebec, G1V 4M6
White Hills Medical Clinic
St. John's, Newfoundland and Labrador, A1A 3R5
Canadian Phase Onward Inc.
Toronto, Ontario, M3H 5S4
Manna Research
Toronto, Ontario, M9W 4L6
James K. Lai, MD., Inc.
Vancouver, British Columbia, V5K 1K3

Other trials in Canada

Japan6 sites

Tajima Clinic
Edogawa-ku, Tokyo
Hachiouji Junkanki clinic
Hachiōji, Tokyo
Saino Clinic
Tokorozawa, Saitama
Kubo Clinic
Yokohama, Kanagawa
Nagatsuta family clinic
Yokohama, Kanagawa
Sakakibara Clinic, Wakaumekai Medical Corporation
Yokohama, Kanagawa

Other trials in Japan

Australia4 sites

Brisbane South Clinical Research Centre
Carina Heights, Queensland, 4152
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
Emeritus Research
Malvern, Victoria, 3145
Australian Clinical Research Network
Maroubra, New South Wales, 2035

Other trials in Australia

Mexico4 sites

Arke Estudios Clinicos S.A.
México, D.f., 06700
Centro Respiratorio de Mexico S.C.
México, D.f., 14050
Centro de Estudios Clinicos y Especialidades Medicas SC
Monterrey, Nuevo León, 64620
Clinica de Enfermedades Cronicas y de Procedimientos Especiales S.C.
Morelia, Michoacán, 58249

Other trials in Mexico

Egypt3 sites

Alexandria University
Alexandria
Ain Shams University Hospital
Cairo
El Fayoum university hospital
El Fayoum Qesm

Other trials in Egypt

About this study

Official 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

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.

Conditions: Smoking Cessation
Being tested: Varenicline Tartrate, Placebo
Keywords: smoking reduction, smoking cessation
Medical subject headings: Smoking Cessation, Smoking Reduction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Varenicline TartrateDrug
Varenicline Tartrate oral tablets 2 (0.5mg) tablets twice a day for 24 weeks (first week titration)
PlaceboDrug
Matching placebo 2 oral tablets twice a day for 24 weeks (first week titration)

Study groups in NCT01370356
Study group	Role	What they receive
Varenicline Tartrate	Active comparator	Not described Receives: Drug: Varenicline Tartrate
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Week 15 - 24

Secondary outcomes (4)

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).
Measured: Week 21 - 24
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).
Measured: Weeks 21 - 52
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).
Measured: Week 12, 24, and 52
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).
Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2011Jul 2013

First posted9 Jun 2011 (estimated)
Study startJul 2011
Primary completionJul 2013
Study completionJul 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Smoking CessationStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,510 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01370356
Sponsor's protocol ID: A3051075
Other IDs: REDUCE TO QUIT
Status last verified: Aug 2014
First submitted: 8 Jun 2011
Last updated: 1 Sep 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
PubMed 37142273
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.
PubMed 34611902
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.
PubMed 28365035
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.
PubMed 25688780

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT01370356
Acronym / sponsor ID: A3051075
Conditions: Smoking Cessation
Keywords: smoking reduction, smoking cessation
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,510 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jul 2011
Primary completion: Jul 2013 (actual)
Study completion: Jul 2013 (actual)
First posted: 9 Jun 2011 (estimated)
Results: Posted 1 Sep 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Varenicline Tartrate	Active comparator	Drug: Varenicline Tartrate
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Varenicline TartrateVarenicline Tartrate oral tablets 2 (0.5mg) tablets twice a day for 24 weeks (first week titration)	Drug	Varenicline Tartrate
PlaceboMatching placebo 2 oral tablets twice a day for 24 weeks (first week titration)	Drug	Placebo

Primary outcome

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).

4 secondary outcomes

Percentage of Participants With CO Confirmed 4-Week CA From Smoking
Time frame: Week 21 - 24
Percentage of Participants With CO Confirmed Long Term CA From Smoking
Time frame: Weeks 21 - 52
Percentage of Participants With 7-Day Point Prevalence of Smoking Cessation
Time frame: Week 12, 24, and 52
Percentage of Participants With 4-Week Point Prevalence of Smoking Cessation
Time frame: Week 52

Results and safety

Results posted to the registry on 1 Sep 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Varenicline	751	559
Placebo	742	515

Primary outcome: Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking

Time frame: Week 15 - 24. Number. Unit: percentage of participants

Measure	Varenicline n = 760	Placebo n = 750
Value	32.1	6.9

Varenicline vs Placebo: Odds Ratio (OR): 8.74 (95% CI 6.09 to 12.53), p <0.0001, Regression, Logistic

Population analysed: The Full Analysis Set was referred to as the Intent-to-Treat (ITT) population and was defined as all randomized participants. The ITT population was the primary analysis set for the efficacy analyses in this study.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: All AEs (serious and nonserious) were recorded from the date of first dose of study drug (Baseline) up to 30 days after the date of last dose of study drug.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Varenicline	28 of 751 (3.7%)	467 of 751 (62.2%)	Not reported
Placebo	16 of 742 (2.2%)	339 of 742 (45.7%)	Not reported

Limitations and caveats (from the sponsor): Two cases of fetal exposure during pregnancy occurred but are not included in the SAE section as they did not meet the criteria of serious in the safety database. One of them relates to a non-study participant who was the study participant's partner.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37142273Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
Derived from this study: PubMed 34611902Hartmann-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.
Derived from this study: PubMed 28365035Nakamura 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.
Derived from this study: PubMed 25688780Ebbert 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.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

65 sites in 10 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Varenicline Tartrate in people with Smoking Cessation, run by Pfizer at 65 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in United States, Czechia, Germany, Taiwan, United Kingdom and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking (time frame: Week 15 - 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01370356, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2014.