Tobacco Use CessationPhase 4NCT00717093

Study Evaluating The Efficacy Of Varenicline In Cessation Of Oral Smokeless Tobacco Use

A Phase 4 study testing Varenicline Tartrate in people with Tobacco Use Cessation, run by Pfizer at 16 sites in 2 countries.

Completed

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

Official record

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Trial summary

The primary goal of this study is to compare efficacy of varenicline to placebo for cessation of use of smokeless tobacco. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Tobacco Use Cessation
What is being tested?: Varenicline Tartrate
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 432 participants
Where: 16 sitesin 2 countries
Study dates: Aug 2008to Jul 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female daily smokeless tobacco users aged 18 years and older, who are motivated to stop use of all tobacco products.
Subjects must be daily users of nicotine containing smokeless tobacco and using smokeless tobacco on at least 8 occasions per day averaged over a week.
Have used smokeless tobacco for at least 1 year prior to screening with no period of abstinence >3 months in the past year.

Who cannot join

Subjects using nicotine containing products (including smoking tobacco) other than smokeless tobacco for 3 months prior to screening.
Subjects with exhaled Carbon Monoxide (CO) >10 ppm at baseline.
Subjects who have used varenicline, bupropion, or NRT within 3 months of screening.
Subjects currently or within the past 12 months requiring treatment for depression or have a current or prior history of panic disorder, psychosis, bipolar disorder or any other serious mental illness.

Trial locations and contacts

16 sites in 2 countries.

Country

City, postcode or hospital

16 sites in 2 countries

Sweden9 sites

Pfizer Investigational Site
Gothenburg, 413 45
Pfizer Investigational Site
Helsingborg, 254 52
Pfizer Investigational Site
Jarfalla, 177 31
Pfizer Investigational Site
Karlstad, 652 24,
Pfizer Investigational Site
Örebro, 701 85
Pfizer Investigational Site
Södertälje, 151 87
Pfizer Investigational Site
Stockholm, 118 91
Pfizer Investigational Site
Sundsvall, 852 31
Pfizer Investigational Site
Umeå, 901 85

Other trials in Sweden

Norway7 sites

Pfizer Investigational Site
Florø, 6900
Pfizer Investigational Site
Hafrsfjord, 4042
Pfizer Investigational Site
Hamar, 2317
Pfizer Investigational Site
Hønefoss, 3515
Pfizer Investigational Site
Oslo, 0407
Pfizer Investigational Site
Rådal, 5235
Pfizer Investigational Site
Trondheim, 7034

Other trials in Norway

About this study

Official title: A Randomized, Multicenter, Double Blind, Placebo Controlled Study Evaluating The Efficacy Of Varenicline In Cessation Of Oral Smokeless Tobacco Use

The primary goal of this study is to compare efficacy of varenicline to placebo for cessation of use of smokeless tobacco.

Conditions: Tobacco Use Cessation
Being tested: Varenicline Tartrate, Placebo
Medical subject headings: Tobacco Use Cessation

What participants receive

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

Varenicline TartrateDrug
Also called Champix, Chantix, CP-526,555
Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.
PlaceboDrug
Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.

Study groups in NCT00717093
Study group	Role	What they receive
Active	Experimental	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.

Number of Subjects With a 4 Week Continuous Quit Rate (CQR) From Smokeless Tobacco
Number of subjects who reported no use of nicotine-containing products by answering "No" to the nicotine use inventory (NUI) question: Has the subject used any nicotine-containing products in the last 7 days (Week 9) or since last study visit (Week 10 through 12) and confirmed salivary cotinine <= 15 ng/mL.
Measured: Weeks 9 through 12

Secondary outcomes (3)

Number of Subjects With Continuous Abstinence (CA) of Smokeless Tobacco Use
Number of subjects who remainded abstinent from the period defined as start of the primary endpoint (Week 9) through the end of follow up (Week 26) by reporting no use of nicotine-containing products and confirmed salivary cotinine <= 15 ng/mL.
Measured: Week 9 through 12, Week 26
Number of Subjects With Long Term Quit Rate (LTQR) of Smokeless Tobacco
Number of subjects who were responders for the primary endpoint (4-week CQR for Weeks 9 through 12) and who had no more than 6 cumulative days of using nicotine containing products from Week 12 through Week 26.
Measured: Week 26
Number of Subjects With 7-day Point Prevalence (PP) of Abstinence at the End of Treatment (Week 12) and at the End of Study (Week 26)
Number of subjects at Week 12 and Week 26 reporting no use of nicotine-containing products in the last 7 days and confirmed salivary cotinine <= 15 ng/mL.
Measured: Week 12, Week 26

Timeline

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

Aug 2008Jul 2009

First posted16 Jul 2008 (estimated)
Study startAug 2008
Primary completionApr 2009
Study completionJul 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 (2)Papers the sponsor has linked to this study.
Other trials for Tobacco Use 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: 432 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00717093
Sponsor's protocol ID: A3051104
Status last verified: Jun 2015
First submitted: 15 Jul 2008
Last updated: 23 Jul 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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
Fagerstrom K, Gilljam H, Metcalfe M, Tonstad S, Messig M. Stopping smokeless tobacco with varenicline: randomised double blind placebo controlled trial. BMJ. 2010 Dec 6;341:c6549. doi: 10.1136/bmj.c6549.
PubMed 21134997

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

Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
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All Tobacco Use Cessation trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Multicenter, Double Blind, Placebo Controlled Study Evaluating The Efficacy Of Varenicline In Cessation Of Oral Smokeless Tobacco Use
ClinicalTrials.gov ID: NCT00717093
Acronym / sponsor ID: A3051104
Conditions: Tobacco Use Cessation
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 432 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Aug 2008
Primary completion: Apr 2009 (actual)
Study completion: Jul 2009 (actual)
First posted: 16 Jul 2008 (estimated)
Results: Posted 18 May 2010

Clinical summary

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

The primary goal of this study is to compare efficacy of varenicline to placebo for cessation of use of smokeless tobacco.

Study design

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

Arm	Type	Receives
Active	Experimental	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 or female daily smokeless tobacco users aged 18 years and older, who are motivated to stop use of all tobacco products.
Subjects must be daily users of nicotine containing smokeless tobacco and using smokeless tobacco on at least 8 occasions per day averaged over a week.
Have used smokeless tobacco for at least 1 year prior to screening with no period of abstinence >3 months in the past year.

Key exclusion criteria (4 listed)

Subjects using nicotine containing products (including smoking tobacco) other than smokeless tobacco for 3 months prior to screening.
Subjects with exhaled Carbon Monoxide (CO) >10 ppm at baseline.
Subjects who have used varenicline, bupropion, or NRT within 3 months of screening.
Subjects currently or within the past 12 months requiring treatment for depression or have a current or prior history of panic disorder, psychosis, bipolar disorder or any other serious mental illness.

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 TartrateAlso: Champix, Chantix, CP-526,555Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.	Drug	Active
PlaceboSubjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.	Drug	Placebo

Primary outcome

Number of Subjects With a 4 Week Continuous Quit Rate (CQR) From Smokeless Tobacco
Time frame: Weeks 9 through 12
Number of subjects who reported no use of nicotine-containing products by answering "No" to the nicotine use inventory (NUI) question: Has the subject used any nicotine-containing products in the last 7 days (Week 9) or since last study visit (Week 10 through 12) and confirmed salivary cotinine <= 15 ng/mL.

3 secondary outcomes

Number of Subjects With Continuous Abstinence (CA) of Smokeless Tobacco Use
Time frame: Week 9 through 12, Week 26
Number of Subjects With Long Term Quit Rate (LTQR) of Smokeless Tobacco
Time frame: Week 26
Number of Subjects With 7-day Point Prevalence (PP) of Abstinence at the End of Treatment (Week 12) and at the End of Study (Week 26)
Time frame: Week 12, Week 26

Results and safety

Results posted to the registry on 18 May 2010, 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 Tartrate	214	170
Placebo	218	170

Primary outcome: Number of Subjects With a 4 Week Continuous Quit Rate (CQR) From Smokeless Tobacco

Time frame: Weeks 9 through 12. Number. Unit: participants

Measure	Varenicline Tartrate n = 213	Placebo n = 218
Value	125	85

Varenicline Tartrate vs Placebo: Odds Ratio (OR): 2.39 (95% CI 1.59 to 3.58), p <0.0001, Regression, Logistic

Population analysed: Intent to treat (ITT)

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Varenicline Tartrate	2 of 213 (0.9%)	151 of 213 (70.9%)	Not reported
Placebo	3 of 218 (1.4%)	107 of 218 (49.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 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 21134997Fagerstrom K, Gilljam H, Metcalfe M, Tonstad S, Messig M. Stopping smokeless tobacco with varenicline: randomised double blind placebo controlled trial. BMJ. 2010 Dec 6;341:c6549. doi: 10.1136/bmj.c6549.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Tobacco Use Cessation

Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Active, not recruiting
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Recruiting
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Recruiting
Social Media Support Groups for Adolescent Vaping Cessation
Vaping, Vaping Cessation

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

16 sites in 2 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 Tobacco Use Cessation, run by Pfizer at 16 sites in 2 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 23 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Sweden, Norway. 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 18 May 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?

Number of Subjects With a 4 Week Continuous Quit Rate (CQR) From Smokeless Tobacco (time frame: Weeks 9 through 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 NCT00717093, 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 23 Jul 2015.