Smoking CessationPhase 4NCT00691483
Randomized Study Comparing the Efficacy and Safety of Varenicline Tartrate to Placebo in Smoking Cessation When Subjects Are Allowed to Set Their Own Quit Date
A Phase 4 study testing varenicline in people with Smoking Cessation, run by Pfizer at 33 sites in 14 countries.
Trial summary
The hypothesis is that varenicline will be effective (compared with placebo) for smoking cessation when subjects are allowed to set their own quit date within the first 5 weeks of treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- varenicline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 659 participants
- Where
- 33 sitesin 14 countries
- Study dates
- Sep 2008to Dec 2009
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women
- 18 to 75 yrs old
- Motivated to stop smoking
- Smoke at least 10 cigarettes/day
Who cannot join
- Active psychiatric disease
- Severe or unstable cardiovascular or pulmonary disease
- Current or recent treatment to stop smoking
- Previous use of varenicline
Trial locations and contacts
33 sites in 14 countries.
33 sites in 14 countries
United States12 sites
Pfizer Investigational Site
Bridgeville, Pennsylvania, 15017
Pfizer Investigational Site
Endwell, New York, 13760
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Lexington, Kentucky, 40509
Pfizer Investigational Site
Litchfield Park, Arizona, 85340
Pfizer Investigational Site
Los Angeles, California, 90095
Pfizer Investigational Site
Milford, Massachusetts, 01757
Pfizer Investigational Site
Nashville, Tennessee, 37203
Pfizer Investigational Site
Omaha, Nebraska, 68116-2004
Pfizer Investigational Site
Overland Park, Kansas, 66212
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19146
Pfizer Investigational Site
Santa Ana, California, 92705
China3 sites
Pfizer Investigational Site
Beijing, 100020
Pfizer Investigational Site
Guangzhou, 510120
Pfizer Investigational Site
Shenyang, Liaoning, 110016
Canada2 sites
Pfizer Investigational Site
Calgary, Alberta, T1Y 6J4
Pfizer Investigational Site
Québec, Quebec, G1V 4M6
Czechia2 sites
Pfizer Investigational Site
Brno, 656 91
Pfizer Investigational Site
Prague, 120 00
Germany2 sites
Pfizer Investigational Site
Berlin, 10787
Pfizer Investigational Site
Göttingen, 37075
Hungary2 sites
Pfizer Investigational Site
Budapest, 1525
Pfizer Investigational Site
Debrecen, 4012
South Korea2 sites
Pfizer Investigational Site
Seoul, 110-744
Pfizer Investigational Site
Seoul, 135-710
Taiwan2 sites
Pfizer Investigational Site
Gwei Shan Township, Taoyuan County, 333
Pfizer Investigational Site
Kaohsiung City, 813
About this study
Official title: A Phase 4, Prospective, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate Smoking Cessation With Varenicline Tartrate Compared With Placebo In The Setting Of Patient Self-Selected (Flexible) Quit Date
The hypothesis is that varenicline will be effective (compared with placebo) for smoking cessation when subjects are allowed to set their own quit date within the first 5 weeks of treatment.
- Conditions
- Smoking Cessation
- Being tested
- placebo, varenicline
- Keywords
- smoking cessation, smoking treatment, patient self-selected quit date
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
placebo tablet taken orally twice daily for 12 weeks
vareniclineDrug
Also called Chantix, Champix
varenicline tablets, 1 mg taken orally twice daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
| varenicline | Experimental | Not described Receives: Drug: varenicline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With 4-week Continuous Abstinence (CA)
The percentage of participants who reported complete abstinence from cigarette smoking and other nicotine use (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO) >10 parts per million (ppm) at any visits Week 9 through Week 12. A participant was considered a responder if they met the following criterion: said they had not smoked or used nicotine products 'since the last visit' and did not have CO >10 ppm.
Measured: Week 9 through Week 12
Secondary outcomes (4)
Percentage of Participants With Continuous Abstinence (CA) From Smoking Weeks 9-24
Percentage of participants with CA from cigarette smoking and other nicotine-containing (treatment phase) or tobacco (non-treatment phase) products use, who did not have CO >10 ppm at any visits Week 9 through Week 24. A participant was considered a responder if they met the following criterion: said they had not smoked or used nicotine products 'since the last visit' and did not have CO >10 ppm.
Measured: Week 9 through Week 24
Percentage of Participants With Long Term Quit Through Week 24
Responder for the primary endpoint of CA from Week 9 through Week 12 and who had no more than 6 days of smoking during the non-treatment phase of the study. For Weeks 13, 16, 20, and 24, long term quit was determined by CO-confirmed in-clinic visit.
Measured: Week 9 through Week 24
Percentage of Participants With 7-day Point Prevalence of Nonsmoking (Smoking Cessation)
Percentage of participants with complete abstinence from cigarette smoking or other nicotine-containing (treatment phase) or tobacco (non-treatment phase) products use for the 7 days prior to Week 12 and Week 24, respectively, who did not have CO >10 ppm at any visits. CO-confirmed in-clinic visit.
Measured: Week 12 and Week 24
Percentage of Participants With 4-week Point Prevalence of Nonsmoking
Percentage of participants with complete abstinence from cigarette smoking or use of tobacco products for the 4 weeks prior to Week 24 who did not have CO >10 ppm at any visits.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2009
- Study completionDec 2009
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 (3)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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 659 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00691483
- Sponsor's protocol ID
- A3051095
- Status last verified
- Oct 2015
- First submitted
- 3 Jun 2008
- Last updated
- 20 Nov 2015
- 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 37142273Hughes JR, Russ C, Messig MA. Association of deferring a quit attempt with smoking cessation success: a secondary analysis. J Subst Abuse Treat. 2014 Feb;46(2):264-7. doi: 10.1016/j.jsat.2013.08.015. Epub 2013 Sep 24.
PubMed 24074849Rennard S, Hughes J, Cinciripini PM, Kralikova E, Raupach T, Arteaga C, St Aubin LB, Russ C; Flexible Quit Date Study Group. A randomized placebo-controlled trial of varenicline for smoking cessation allowing flexible quit dates. Nicotine Tob Res. 2012 Mar;14(3):343-50. doi: 10.1093/ntr/ntr220. Epub 2011 Nov 11.
PubMed 22080588
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Prospective, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate Smoking Cessation With Varenicline Tartrate Compared With Placebo In The Setting Of Patient Self-Selected (Flexible) Quit Date
- ClinicalTrials.gov ID
- NCT00691483
- Acronym / sponsor ID
- A3051095
- Conditions
- Smoking Cessation
- Keywords
- smoking cessation, smoking treatment, patient self-selected quit date
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 659 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 5 Jun 2008 (estimated)
- Results
- Posted 30 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis is that varenicline will be effective (compared with placebo) for smoking cessation when subjects are allowed to set their own quit date within the first 5 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placebo |
| varenicline | Experimental | Drug: varenicline |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women
- 18 to 75 yrs old
- Motivated to stop smoking
- Smoke at least 10 cigarettes/day
Key exclusion criteria (4 listed)
- Active psychiatric disease
- Severe or unstable cardiovascular or pulmonary disease
- Current or recent treatment to stop smoking
- Previous use of varenicline
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 |
|---|---|---|
| placeboplacebo tablet taken orally twice daily for 12 weeks | Drug | placebo |
| vareniclineAlso: Chantix, Champixvarenicline tablets, 1 mg taken orally twice daily for 12 weeks | Drug | varenicline |
Primary outcome
Percentage of Participants With 4-week Continuous Abstinence (CA)
Time frame: Week 9 through Week 12
The percentage of participants who reported complete abstinence from cigarette smoking and other nicotine use (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO) >10 parts per million (ppm) at any visits Week 9 through Week 12. A participant was considered a responder if they met the following criterion: said they had not smoked or used nicotine products 'since the last visit' and did not have CO >10 ppm.
4 secondary outcomes
Percentage of Participants With Continuous Abstinence (CA) From Smoking Weeks 9-24
Time frame: Week 9 through Week 24
Percentage of Participants With Long Term Quit Through Week 24
Time frame: Week 9 through Week 24
Percentage of Participants With 7-day Point Prevalence of Nonsmoking (Smoking Cessation)
Time frame: Week 12 and Week 24
Percentage of Participants With 4-week Point Prevalence of Nonsmoking
Time frame: Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
- 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 24074849Hughes JR, Russ C, Messig MA. Association of deferring a quit attempt with smoking cessation success: a secondary analysis. J Subst Abuse Treat. 2014 Feb;46(2):264-7. doi: 10.1016/j.jsat.2013.08.015. Epub 2013 Sep 24.
- Derived from this study: PubMed 22080588Rennard S, Hughes J, Cinciripini PM, Kralikova E, Raupach T, Arteaga C, St Aubin LB, Russ C; Flexible Quit Date Study Group. A randomized placebo-controlled trial of varenicline for smoking cessation allowing flexible quit dates. Nicotine Tob Res. 2012 Mar;14(3):343-50. doi: 10.1093/ntr/ntr220. Epub 2011 Nov 11.
- 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
33 sites in 14 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 33 sites in 14 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 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 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, China, Canada, Czechia, Germany and 9 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 30 Sep 2010). 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 4-week Continuous Abstinence (CA) (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 NCT00691483, which also lists 3 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 20 Nov 2015.