Smoking CessationPhase 2NCT00150254
12 Week Evaluation of the Safety and Efficacy of 4 Dosing Strategies of CP-526,555 and Placebo for Smoking Cessation.
A Phase 2 study testing CP-526,555 (varenicline) in people with Smoking Cessation, run by Pfizer at 13 sites in United States.
Trial summary
The purpose of the study is to measure the safety and efficacy of four dosing strategies of CP-526,555 for 12 weeks compared with placebo for smoking cessation. Post-treatment follow-up of smoking status to one year from randomization was performed in a non-treatment extension Protocol A3051018 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- CP-526,555 (varenicline)
- How many people
- 625 participants
- Where
- 13 sitesUnited States
- Study dates
- Sep 2001to Oct 2002
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have smoked on average of at least ten cigarettes per day during the past year
- Subjects must have no period of abstinence greater than three months in the past year
Who cannot join
- Subjects with any history of clinically significant cardiovascular disease
- Uncontrolled hypertension
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Pfizer Investigational Site
Cincinnati, Ohio
Pfizer Investigational Site
Farmington, Connecticut
Pfizer Investigational Site
Houston, Texas
Pfizer Investigational Site
Jackson, Florida
Pfizer Investigational Site
Jackson, Mississippi
Pfizer Investigational Site
Lexington, Kentucky
Pfizer Investigational Site
Los Angeles, California
Pfizer Investigational Site
New Orleans, Louisiana
Pfizer Investigational Site
Omaha, Nebraska
Pfizer Investigational Site
Portland, Oregon
Pfizer Investigational Site
San Bernardino, California
Pfizer Investigational Site
Upland, California
Pfizer Investigational Site
West Covina, California
About this study
Official title: A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety and Efficacy of Four Dosing Strategies for CP-526,555 ( 0.5 mg BID Titrated, 0.5 mg BID, 1 mg BID, and Titrated 1 mg BID ) in Smoking Cessation
The purpose of the study is to measure the safety and efficacy of four dosing strategies of CP-526,555 for 12 weeks compared with placebo for smoking cessation. Post-treatment follow-up of smoking status to one year from randomization was performed in a non-treatment extension Protocol A3051018
- Conditions
- Smoking Cessation
- Being tested
- CP-526,555 (varenicline)
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-526,555 (varenicline)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
4 week continuous quit rate (CQR) at Weeks 9-12 and Weeks 4-7
Secondary outcomes (6)
Continuous abstinence rate from target quit date to end of treatment (Week 12)
Carbon monoxide(CO)-confirmed 7-day point prevalence of abstinence at Week 12
Number of cigarettes smoked per day
Urge to smoke and withdrawal symptoms assessed by Minnesota Nicotine Withdrawal Scale
Rewarding effects of smoking assessed by Smoking Effects Inventory
Weight change from baselin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startSep 2001
- Study completionOct 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 625 participants
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
- NCT00150254
- Sponsor's protocol ID
- A3051007
- Status last verified
- Jun 2007
- First submitted
- 6 Sep 2005
- Last updated
- 4 Jun 2007
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety and Efficacy of Four Dosing Strategies for CP-526,555 ( 0.5 mg BID Titrated, 0.5 mg BID, 1 mg BID, and Titrated 1 mg BID ) in Smoking Cessation
- ClinicalTrials.gov ID
- NCT00150254
- Acronym / sponsor ID
- A3051007
- Conditions
- Smoking Cessation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 625 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2001
- Study completion
- Oct 2002 (actual)
- First posted
- 8 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to measure the safety and efficacy of four dosing strategies of CP-526,555 for 12 weeks compared with placebo for smoking cessation. Post-treatment follow-up of smoking status to one year from randomization was performed in a non-treatment extension Protocol A3051018
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects must have smoked on average of at least ten cigarettes per day during the past year
- Subjects must have no period of abstinence greater than three months in the past year
Key exclusion criteria (2 listed)
- Subjects with any history of clinically significant cardiovascular disease
- Uncontrolled hypertension
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 |
|---|---|---|
| CP-526,555 (varenicline) | Drug | – |
Primary outcome
4 week continuous quit rate (CQR) at Weeks 9-12 and Weeks 4-7
6 secondary outcomes
Continuous abstinence rate from target quit date to end of treatment (Week 12)
Carbon monoxide(CO)-confirmed 7-day point prevalence of abstinence at Week 12
Number of cigarettes smoked per day
Urge to smoke and withdrawal symptoms assessed by Minnesota Nicotine Withdrawal Scale
Rewarding effects of smoking assessed by Smoking Effects Inventory
Weight change from baselin
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2007.
- 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.
- 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
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CP-526,555 (varenicline) in people with Smoking Cessation, run by Pfizer at 13 sites in United States.
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 2 inclusion and 2 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 4 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
4 week continuous quit rate (CQR) at Weeks 9-12 and Weeks 4-7. 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 NCT00150254, which also lists 1 linked publication.
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 4 Jun 2007.