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

February 29, 2012 updated by: Pfizer

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1380

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: 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: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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?"
Week 26

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Biochemically Confirmed 7-Day PP Abstinence From Tobacco
Time Frame: Week 26
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]).
Week 26
Percentage of Participants With Continuous Abstinence (CA) at Weeks 26, 39, and 52
Time Frame: Week 26, Week 39, and Week 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.
Week 26, Week 39, and Week 52
Percentage of Participants With 7-Day PP of Abstinence at Week 13
Time Frame: 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?"
Week 13
Percentage of Participants With Long Term Quit Rate (LTQR) Through Weeks 26 to 52
Time Frame: Week 26 to Week 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
Week 26 to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 7, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 29, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A3051116

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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