Smoking CessationPhase 4ACCESSATIONNCT00818207

Impact Of Smoking Cessation Treatment Reimbursement On The Quit Rates In Smokers Motivated To Quit

A Phase 4 study testing Full Smoking Cessation Treatment Coverage (100%) and No Smoking Cessation Treatment Coverage (0%) in people with Smoking Cessation and Insurance Coverage, run by Pfizer at 56 sites in Canada.

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

This study is based on the hypothesis that access to smoking cessation treatment (SCT) reimbursement may significantly increase the number of successful quitters in a population of smokers motivated to quit by: 1) increasing the use of SCTs in quit attempts, and 2) by improving subject adherence to treatment. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Smoking Cessation, Insurance Coverage
What is being tested?: Full Smoking Cessation Treatment Coverage (100%) and No Smoking Cessation Treatment Coverage (0%)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,380 participants
Where: 56 sitesCanada
Study dates: Mar 2009to Sep 2010
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Daily smokers (10 cigarettes per day or more);
Smokers motivated to make a quit attempt within the next 14 days;
Potential subjects must be outpatients;
A subject must have a stable mental and physical medical condition (as per investigator's judgment).

Who cannot join

A subject currently eligible for smoking cessation treatment (SCT) reimbursement, whether from a public or a private drug insurance;
A subject with an unknown drug insurance status;
A subject living in a household where there is someone already recruited in the study;
A subject with an unfilled SCT prescription issued within the past three months or with an unused SCT product;
A subject with a life-threatening illness (ie, known or suspected cancer or other disease with a life expectancy of less than one year).

Trial locations and contacts

56 sites in 1 country.

City, postcode or hospital

56 sites in 1 country

Canada56 sites

Pfizer Investigational Site
Aylmer, Ontario, N5H 1K9
Pfizer Investigational Site
Bay Roberts, Newfoundland and Labrador, A0A 1G0
Pfizer Investigational Site
Bolton, Ontario, L7E 1E8
Pfizer Investigational Site
Burnaby, British Columbia, V5G 1T4
Pfizer Investigational Site
Charlottetown, Prince Edward Island, C1A 1L2
Pfizer Investigational Site
Charlottetown, Prince Edward Island, C1A 5Y9
Pfizer Investigational Site
Chilliwack, British Columbia, V2P 4M9
Pfizer Investigational Site
Collingwood, Ontario, L9Y 1W3
Pfizer Investigational Site
Coquitlam, British Columbia, V3K 3P4
Pfizer Investigational Site
Corunna, Ontario, N0N 1G0
Pfizer Investigational Site
Hamilton, Ontario, L8M 1K7
Pfizer Investigational Site
Hamilton, Ontario, L8N 4A6
Pfizer Investigational Site
Kamloops, British Columbia, V2C 1K7
Pfizer Investigational Site
Kelowna, British Columbia, V1Y 3G8
Pfizer Investigational Site
Langley, British Columbia, V3A 4H9
Pfizer Investigational Site
London, Ontario, N5W 3C6
Pfizer Investigational Site
London, Ontario, N5W 6A2
Pfizer Investigational Site
London, Ontario, N5Y 5K7
Pfizer Investigational Site
London, Ontario, N6A 5G6
Pfizer Investigational Site
London, Ontario, N6A 5W9
Pfizer Investigational Site
London, Ontario, N6C 4Y7
Pfizer Investigational Site
London, Ontario, N6H 4P2
Pfizer Investigational Site
London, Ontario, N6P 1A9
Pfizer Investigational Site
Montague, Prince Edward Island, C0A 1R0
Pfizer Investigational Site
Newmarket, Ontario, L3Y 5G8
Pfizer Investigational Site
North Vancouver, British Columbia, V7N 4M2
Pfizer Investigational Site
Ottawa, Ontario, K2C 3R2
Pfizer Investigational Site
Paradise, Newfoundland and Labrador, A1L 1C6
Pfizer Investigational Site
Penticton, British Columbia, V2A 5C8
Pfizer Investigational Site
Regina, Saskatchewan, S4P 3X1
Pfizer Investigational Site
Sarnia, Ontario, N7T 4X3
Pfizer Investigational Site
Saskatoon, Saskatchewan, S7K 6Y6
Pfizer Investigational Site
Saskatoon, Saskatchewan, S7K 7H9
Pfizer Investigational Site
St. John's, Newfoundland and Labrador, A1A 3R5
Pfizer Investigational Site
St. John's, Newfoundland and Labrador, A1E 2E2
Pfizer Investigational Site
Stayner, Ontario, L0M 1S0
Pfizer Investigational Site
Strathroy, Ontario, N7G 1Y7
Pfizer Investigational Site
Sydney, Nova Scotia, B1P 1C6
Pfizer Investigational Site
Thornhill, Ontario, L4J 6W6
Pfizer Investigational Site
Toronto, Ontario, M3H 5S4
Pfizer Investigational Site
Toronto, Ontario, M5G 1N8
Pfizer Investigational Site
Toronto, Ontario, M6L 3C9
Pfizer Investigational Site
Toronto, Ontario, M8V 3X8
Pfizer Investigational Site
Toronto, Ontario, M9V 4B4
Pfizer Investigational Site
Toronto, Ontario, M9W 4L6
Pfizer Investigational Site
Vancouver, British Columbia, V5K 1K3
Pfizer Investigational Site
Vancouver, British Columbia, V5Z 1M9
Pfizer Investigational Site
Victoria, British Columbia, V8R 1J8
Pfizer Investigational Site
Windsor, Nova Scotia, B0N 2T0
Pfizer Investigational Site
Winnipeg, Manitoba, R2H 2A6
Pfizer Investigational Site
Winnipeg, Manitoba, R2M 3T2
Pfizer Investigational Site
Winnipeg, Manitoba, R2V 4W3
Pfizer Investigational Site
Winnipeg, Manitoba, R3A 1R9
Pfizer Investigational Site
Winnipeg, Manitoba, R3C 0N2
Pfizer Investigational Site
Winnipeg, Manitoba, R3E 3P4
Pfizer Investigational Site
Woodstock, Ontario, N4S 5P5

Other trials in Canada

About this study

Official title: A Pragmatic, Randomized, Controlled Study Evaluating The Impact Of Access To Smoking Cessation Treatment Reimbursement On The Proportion Of Successful Quitters In A Canadian Population Of Smokers Motivated To Quit

Conditions: Smoking Cessation, Insurance Coverage
Being tested: Full Smoking Cessation Treatment Coverage (100%), No Smoking Cessation Treatment Coverage (0%)
Keywords: Smoking cessation, quit rates, reimbursement, drug coverage, effectiveness, cost-effectiveness, health policy, drug utilization, adherence, urine cotinine.
Medical subject headings: Smoking Cessation

What participants receive

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

Full Smoking Cessation Treatment Coverage (100%)Other
This is a pragmatic study in which the intervention is a health policy (SCT reimbursement). Champix (varenicline), Zyban (bupropion) and NRTs (nicotine replacement therapies; patches, gums) are SCT eligible for reimbursement. Prescriptions will be issued as per the most recent version of the Product Monograph of the prescribed SCT or equivalent.
No Smoking Cessation Treatment Coverage (0%)Other
None of the subjects recruited in the study have access to SCT reimbursement in real-life. As such, subjects randomized to the control group represent lack of SCT coverage in real-life and are considered to receive standard of care for smoking cessation.

Study groups in NCT00818207
Study group	Role	What they receive
Full Smoking Cessation Treatment Coverage (100%)	Other	A subject randomized to the intervention group will be eligible for smoking cessation treatment (SCT) reimbursement during the 26-week period following the randomization. Receives: Other: Full Smoking Cessation Treatment Coverage (100%)
No Smoking Cessation Treatment Coverage (0%)	Other	Subjects in the control group choosing to quit using an SCT method will not be eligible for smoking cessation treatment (SCT) reimbursement and, thus, will have to purchase their treatment out of pocket. Receives: Other: No Smoking Cessation Treatment Coverage (0%)

What is being measured

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

Percentage of Participants With 7-Day Point Prevalence (PP) of Abstinence
Percentage of participants who self-reported tobacco abstinence for the previous 7 days (7-day PP) with a negative response to the following questions: "Have you smoked any cigarettes (even a puff) in the last 7 days?" and "Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than a Nicotine Replacement Therapy (NRT) (smoking cessation treatment [SCT]) in the last 7 days?"
Measured: Week 26

Secondary outcomes (4)

Percentage of Participants With Biochemically Confirmed 7-Day PP Abstinence From Tobacco
PP tobacco abstinence was adjudicated if the following conditions were met:(a) self-reported tobacco abstinence for the previous 7 days with a negative response to the questions "Have you smoked any cigarettes (even a puff) in the last 7 days?" and "Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than an NRT (SCT) in the last 7 days?" confirmed by negative urine cotinine test results (defined as cotinine levels less than [<]200 nanograms per milliliter [ng/mL]).
Measured: Week 26
Percentage of Participants With Continuous Abstinence (CA) at Weeks 26, 39, and 52
CA from smoking was adjudicated if the following conditions were met:(a) self-reported continuous tobacco abstinence during the defined time point with a negative response to the questions "Have you smoked any cigarettes (even a puff) since the last contact/visit?" at every visit from Week 26 through Week 52 (Weeks 26, 39, and 52) and "Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than an NRT (SCT) since the last contact/visit?" and (b) urine cotinine test results were neither positive (greater than or equal to [≥]200 ng/mL) nor missing.
Measured: Week 26, Week 39, and Week 52
Percentage of Participants With 7-Day PP of Abstinence at Week 13
PP tobacco abstinence was adjudicated if the participant self-reported tobacco abstinence for the previous 7 days with a negative response to the following questions: "Have you smoked any cigarettes (even a puff) in the last 7 days?" and "Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than a NRT (SCT) in the last 7 days?"
Measured: Week 13
Percentage of Participants With Long Term Quit Rate (LTQR) Through Weeks 26 to 52
LTQR was adjudicated if the following conditions were met: the participant self-reported tobacco abstinence for the previous 7 days with a negative response to the following questions: "Have you smoked any cigarettes (even a puff) in the last 7 days?" and "Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than a NRT (SCT) in the last 7 days?" and had no more than 6 cumulative days of using nicotine containing products from Weeks 26 to 52
Measured: Week 26 to Week 52

Timeline

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

Mar 2009Sep 2010

First posted7 Jan 2009 (estimated)
Study startMar 2009
Primary completionMar 2010
Study completionSep 2010

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 (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 4
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,380 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00818207
Sponsor's protocol ID: A3051116
Acronym: ACCESSATION
Status last verified: Feb 2012
First submitted: 6 Jan 2009
Last updated: 30 Mar 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Selby P, Brosky G, Oh P, Raymond V, Arteaga C, Ranger S. A pragmatic, randomized, controlled study evaluating the impact of access to smoking cessation pharmacotherapy coverage on the proportion of successful quitters in a Canadian population of smokers motivated to quit (ACCESSATION). BMC Public Health. 2014 May 7;14:433. doi: 10.1186/1471-2458-14-433.
PubMed 24885542

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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Impacto 2.0: Mobile Smoking Cessation Across Texas
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Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pragmatic, Randomized, Controlled Study Evaluating The Impact Of Access To Smoking Cessation Treatment Reimbursement On The Proportion Of Successful Quitters In A Canadian Population Of Smokers Motivated To Quit
ClinicalTrials.gov ID: NCT00818207
Acronym / sponsor ID: ACCESSATION / A3051116
Conditions: Smoking Cessation, Insurance Coverage
Keywords: Smoking cessation, quit rates, reimbursement, drug coverage, effectiveness, cost-effectiveness, health policy, drug utilization
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,380 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Mar 2009
Primary completion: Mar 2010 (actual)
Study completion: Sep 2010 (actual)
First posted: 7 Jan 2009 (estimated)
Results: Posted 30 Mar 2012

Clinical summary

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

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Full Smoking Cessation Treatment Coverage (100%)	Other	Other: Full Smoking Cessation Treatment Coverage (100%)A subject randomized to the intervention group will be eligible for smoking cessation treatment (SCT) reimbursement during the 26-week period following the randomization.
No Smoking Cessation Treatment Coverage (0%)	Other	Other: No Smoking Cessation Treatment Coverage (0%)Subjects in the control group choosing to quit using an SCT method will not be eligible for smoking cessation treatment (SCT) reimbursement and, thus, will have to purchase their treatment out of pocket.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Daily smokers (10 cigarettes per day or more);
Smokers motivated to make a quit attempt within the next 14 days;
Potential subjects must be outpatients;
A subject must have a stable mental and physical medical condition (as per investigator's judgment).

Key exclusion criteria (5 listed)

A subject currently eligible for smoking cessation treatment (SCT) reimbursement, whether from a public or a private drug insurance;
A subject with an unknown drug insurance status;
A subject living in a household where there is someone already recruited in the study;
A subject with an unfilled SCT prescription issued within the past three months or with an unused SCT product;
A subject with a life-threatening illness (ie, known or suspected cancer or other disease with a life expectancy of less than one year).

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
Full Smoking Cessation Treatment Coverage (100%)This is a pragmatic study in which the intervention is a health policy (SCT reimbursement). Champix (varenicline), Zyban (bupropion) and NRTs (nicotine replacement therapies; patches, gums) are SCT eligible for reimbursement. Prescriptions will be issued as per the most recent version of the Product Monograph of the prescribed SCT or equivalent.	Other	Full Smoking Cessation Treatment Coverage (100%)
No Smoking Cessation Treatment Coverage (0%)None of the subjects recruited in the study have access to SCT reimbursement in real-life. As such, subjects randomized to the control group represent lack of SCT coverage in real-life and are considered to receive standard of care for smoking cessation.	Other	No Smoking Cessation Treatment Coverage (0%)

Primary outcome

Percentage of Participants With 7-Day Point Prevalence (PP) of Abstinence
Time frame: Week 26
Percentage of participants who self-reported tobacco abstinence for the previous 7 days (7-day PP) with a negative response to the following questions: "Have you smoked any cigarettes (even a puff) in the last 7 days?" and "Have you used any nicotine-containing product (such as chew, snuff, pipe, cigar) other than a Nicotine Replacement Therapy (NRT) (smoking cessation treatment [SCT]) in the last 7 days?"

4 secondary outcomes

Percentage of Participants With Biochemically Confirmed 7-Day PP Abstinence From Tobacco
Time frame: Week 26
Percentage of Participants With Continuous Abstinence (CA) at Weeks 26, 39, and 52
Time frame: Week 26, Week 39, and Week 52
Percentage of Participants With 7-Day PP of Abstinence at Week 13
Time frame: Week 13
Percentage of Participants With Long Term Quit Rate (LTQR) Through Weeks 26 to 52
Time frame: Week 26 to Week 52

Results and safety

Results posted to the registry on 30 Mar 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Reimbursement for Smoking Cessation Therapy (SCT)	696	474
No Reimbursement for SCT	684	417

Primary outcome: Percentage of Participants With 7-Day Point Prevalence (PP) of Abstinence

Time frame: Week 26. Number. Unit: Percentage of Participants

Measure	Reimbursement for Smoking Cessation Therapy (SCT) n = 696	No Reimbursement for SCT n = 684
Value	20.8	13.9

Reimbursement for Smoking Cessation Therapy (SCT) vs No Reimbursement for SCT: Odds Ratio (OR): 1.64 (95% CI 1.23 to 2.18), p = 0.0007, Regression, Logistic

Population analysed: Intent to Treat (ITT) Population: all randomized participants

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Reimbursement for Smoking Cessation Therapy (SCT)	35 of 696 (5%)	335 of 696 (48.1%)	Not reported
No Reimbursement for SCT	25 of 684 (3.7%)	246 of 684 (36%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24885542Selby P, Brosky G, Oh P, Raymond V, Arteaga C, Ranger S. A pragmatic, randomized, controlled study evaluating the impact of access to smoking cessation pharmacotherapy coverage on the proportion of successful quitters in a Canadian population of smokers motivated to quit (ACCESSATION). BMC Public Health. 2014 May 7;14:433. doi: 10.1186/1471-2458-14-433.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Smoking Cessation

Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
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Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
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Impacto 2.0: Mobile Smoking Cessation Across Texas
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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

56 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 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 30 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in Canada. 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 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 Mar 2012). 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 7-Day Point Prevalence (PP) of Abstinence (time frame: Week 26). 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 NCT00818207, 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 30 Mar 2012.