You are here

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

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Burnaby, British Columbia, V5G 1T4 Canada
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Smoking Cessation, Insurance Coverage
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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).

NCT00818207
Pfizer
Completed
Impact Of Smoking Cessation Treatment Reimbursement On The Quit Rates In Smokers Motivated To Quit

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Descriptive Information
Brief Title  ICMJE Impact Of Smoking Cessation Treatment Reimbursement On The Quit Rates In Smokers Motivated To Quit
Official Title  ICMJE 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
Brief SummaryThis 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Smoking Cessation
  • Insurance Coverage
Intervention  ICMJE
  • 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%)
    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 Arms  ICMJE
  • 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.
    Intervention: Other: Full Smoking Cessation Treatment Coverage (100%)
  • 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.
    Intervention: Other: No Smoking Cessation Treatment Coverage (0%)
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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 8, 2010)
1380
Original Estimated Enrollment  ICMJE
 (submitted: January 6, 2009)
1352
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion DateMarch 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00818207
Other Study ID Numbers  ICMJE A3051116
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateFebruary 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now