Smoking CessationPhase 4NCT01244061
A Multi-National Study To Assess How Effective And Safe The Smoking Cessation Medicine Varenicline Is In Smokers Who Have Already Tried Varenicline In The Past As A Prescription Medicine From Their Usual Healthcare Provider
A Phase 4 study testing Varenicline in people with Smoking Cessation, run by Pfizer at 37 sites in 8 countries.
Trial summary
The main purpose of this study is to compare the effectiveness and safety of the re-treatment of smokers with varenicline with placebo for smoking cessation during the last 4 weeks of a 12 week course of treatment. 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 498 participants
- Where
- 37 sitesin 8 countries
- Study dates
- Dec 2010to Nov 2012
- 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
- Smokers aged 18 years or above and wanting to stop smoking
- Smokers who have smoked an average of at least 10 cigarettes per day over the last 4 weeks
- Smokers who have tried before to stop smoking at least once with varenicline, and who took varenicline for at least 2 weeks
- The last attempt to stop smoking must be at least 3 months before entering the study
Who cannot join
- Individuals who have not tolerated varenicline well previously, or who have a current or prior medical or psychiatric history that would make entry into the trial inadvisable
- Individuals who have previously participated in clinical trials of varenicline
- Individuals who have been participating in another smoking cessation trial within the last 3 months, or other drug trial within the last 30 days
Trial locations and contacts
37 sites in 8 countries.
37 sites in 8 countries
United States8 sites
The University of Maryland
College Park, Maryland, 20742
Avail Clinical Research, LLC
DeLand, Florida, 32720
The Center for Pharmaceutical Research, PC
Kansas City, Missouri, 64114
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, 40509
Ronald Reagan University of California Los Angeles Medical Center
Los Angeles, California, 90095-6984
University of California Los Angeles David Geffen School of Medicine
Los Angeles, California, 90095
Clinical Research Associates, Inc.
Nashville, Tennessee, 37203
Oregon Health and Science University
Portland, Oregon, 97239-3098
Germany5 sites
Klinische Forschung Berlin
Berlin, 10787
Universitaetsklinikum Goettingen Zentrum Innere Medizin Abteilung Kardiologie und Pneumologie
Göttingen, Germany, 37075
Klinische Forschung Hamburg GmbH
Hamburg, 20253
Ludwig Maximilians-Universitaet Muenchen
München, 80336
FOCUS Clinical Drug Development GmbH
Neuss, 41460
United Kingdom5 sites
Synexus Lancashire Clinical Research Centre
Chorley, Lancashire, PR7 7NA
Synexus Scotland Clinical Research Centre
Glasgow, G20 0SP
Synexus, Merseyside Clinical Research Centre
Liverpool, L22 0LG
William Harvey Research Institute,
London, EC1M 6BQ
Synexus Thames Valley Clinical Research Centre
Reading, Berks, RG2 0TG
Australia4 sites
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
Emeritus Research
Malvern, Victoria, 3145
Australian Clinical Research Network
Maroubra, New South Wales, 2035
AusTrials Australia
Sherwood, Queensland, 4075
Belgium4 sites
Universitair Ziekenhuis Antwerpen, Afdeling Pneumologie
Edegem, 2650
Universitaire Ziekenhuizen Leuven/Pneumologie
Leuven, 3000
Centre Hospitalier Universitaire de Liege
Liège, 4000
Cliniques Universitaires U.C.L. de Mont-Godinne/Laboratoire
Yvoir, 5530
Canada4 sites
Office of Dr. Ronald Collette
Burnaby, British Columbia, V5G 1T4
Clinique des maladies Lipidiques de Quebec
Québec, Quebec, G1V 4M6
White Hills Medical Clinic
St. John's, Newfoundland and Labrador, A1A 3R5
Canadian Phase Onward Inc.
Toronto, Ontario, M3H 5S4
Czechia4 sites
Fakultni nemocnice Brno
Brno, 625 00
Krajska nemocnice Liberec a.s., Plicni oddeleni
Liberec, 460 01
Mestska nemocnice Ostrava, Plicni oddeleni
Ostrava, 728 80
Vseobecna fakultni nemocnice v Praze
Prague, 120 00
France3 sites
CHU de la Cavale Blanche
Brest, 29609
CHU Côte de Nacre, Unité de Coordination de Tabacologie
Caen, 14033
Hopital Arnaud de Villeneuve
Montpellier, 34295
About this study
Official title: A Phase 4 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating The Efficacy And Safety Of Re-Treatment With Varenicline In Subjects Who Are Currently Smoking, And Who Have Previously Taken Varenicline
The main purpose of this study is to compare the effectiveness and safety of the re-treatment of smokers with varenicline with placebo for smoking cessation during the last 4 weeks of a 12 week course of treatment. The study will also assess whether smokers remain abstinent at Week 24 (12 weeks after the end of treatment) and Week 52 (40 weeks after the end of treatment).
- Conditions
- Smoking Cessation
- Being tested
- Varenicline, Placebo
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Varenicline 1mg twice daily
PlaceboDrug
Matched placebo twice daily
| Study group | Role | What they receive |
|---|---|---|
| Varenicline | Experimental | Not described Receives: Drug: Varenicline |
| 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.
Continuous Abstinence Rate (CAR) From Week 9 Through Week 12
The percentage of participants who, from Week 9 through Week 12, reported no smoking and no use of other nicotine-containing products since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO)> 10ppm at any visits during this time frame.
Measured: Week 9 through Week 12
Secondary outcomes (3)
CAR From Week 9 Through Week 52
The percentage of participants who, from Week 9 through Week 52, reported no smoking (Weeks 9 through 52) and no use of other nicotine-containing products (Weeks 9 through 12), or no use of other tobacco products (Weeks 13 through 52), since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have CO >10 ppm at any of these visits during this time frame.
Measured: Week 9 through Week 52
CAR From Week 9 Through Week 24
The percentage of participants who, from Week 9 through Week 24, reported no smoking (Weeks 9 through 24) and no use of other nicotine-containing products (Weeks 9 through 12), or no use of other tobacco products (Weeks 13 through 24), since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have CO >10 ppm at any of these visits during this time frame.
Measured: Week 9 through Week 24
7-day Point Prevalence (PP) of Abstinence at Weeks 12, 24, and 52
The secondary endpoint of 7-day point prevalence of smoking cessation was determined by evaluating a participant's cigarette smoking status, and other nicotine (and/or other tobacco) use, based on the "last 7 days" questions in the Nicotine Use Inventory. Additionally, a participant was not considered a responder if the expired CO was >10 ppm at the time point being summarized. Participants were considered responders independently at each visit.
Measured: Weeks 12, 24 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2010 (estimated)
- Study startDec 2010
- Primary completionNov 2012
- Study completionNov 2012
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 (2)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 498 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01244061
- Sponsor's protocol ID
- A3051139
- Status last verified
- May 2014
- First submitted
- 17 Nov 2010
- Last updated
- 9 Jun 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 37142273Gonzales D, Hajek P, Pliamm L, Nackaerts K, Tseng LJ, McRae TD, Treadow J. Retreatment with varenicline for smoking cessation in smokers who have previously taken varenicline: a randomized, placebo-controlled trial. Clin Pharmacol Ther. 2014 Sep;96(3):390-6. doi: 10.1038/clpt.2014.124. Epub 2014 Jun 9.
PubMed 24911368
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating The Efficacy And Safety Of Re-Treatment With Varenicline In Subjects Who Are Currently Smoking, And Who Have Previously Taken Varenicline
- ClinicalTrials.gov ID
- NCT01244061
- Acronym / sponsor ID
- A3051139
- Conditions
- Smoking Cessation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 498 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 19 Nov 2010 (estimated)
- Results
- Posted 9 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to compare the effectiveness and safety of the re-treatment of smokers with varenicline with placebo for smoking cessation during the last 4 weeks of a 12 week course of treatment. The study will also assess whether smokers remain abstinent at Week 24 (12 weeks after the end of treatment) and Week 52 (40 weeks after the end of treatment).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Varenicline | Experimental | Drug: Varenicline |
| 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 (4 listed)
- Smokers aged 18 years or above and wanting to stop smoking
- Smokers who have smoked an average of at least 10 cigarettes per day over the last 4 weeks
- Smokers who have tried before to stop smoking at least once with varenicline, and who took varenicline for at least 2 weeks
- The last attempt to stop smoking must be at least 3 months before entering the study
Key exclusion criteria (3 listed)
- Individuals who have not tolerated varenicline well previously, or who have a current or prior medical or psychiatric history that would make entry into the trial inadvisable
- Individuals who have previously participated in clinical trials of varenicline
- Individuals who have been participating in another smoking cessation trial within the last 3 months, or other drug trial within the last 30 days
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 |
|---|---|---|
| VareniclineVarenicline 1mg twice daily | Drug | Varenicline |
| PlaceboMatched placebo twice daily | Drug | Placebo |
Primary outcome
Continuous Abstinence Rate (CAR) From Week 9 Through Week 12
Time frame: Week 9 through Week 12
The percentage of participants who, from Week 9 through Week 12, reported no smoking and no use of other nicotine-containing products since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO)> 10ppm at any visits during this time frame.
3 secondary outcomes
CAR From Week 9 Through Week 52
Time frame: Week 9 through Week 52
CAR From Week 9 Through Week 24
Time frame: Week 9 through Week 24
7-day Point Prevalence (PP) of Abstinence at Weeks 12, 24, and 52
Time frame: Weeks 12, 24 and 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 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 24911368Gonzales D, Hajek P, Pliamm L, Nackaerts K, Tseng LJ, McRae TD, Treadow J. Retreatment with varenicline for smoking cessation in smokers who have previously taken varenicline: a randomized, placebo-controlled trial. Clin Pharmacol Ther. 2014 Sep;96(3):390-6. doi: 10.1038/clpt.2014.124. Epub 2014 Jun 9.
- 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
37 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Varenicline in people with Smoking Cessation, run by Pfizer at 37 sites in 8 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 4 inclusion and 3 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 9 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Germany, United Kingdom, Australia, Belgium and 3 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 9 Jun 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?
Continuous Abstinence Rate (CAR) From Week 9 Through Week 12 (time frame: Week 9 through Week 12). 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 NCT01244061, which also lists 2 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 9 Jun 2014.