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

Smoking Cessation Clinical Trial

— ACCESSATION  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00818207
• Other study ID #: A3051116
• Status: Completed
• Phase: Phase 4
• First received: January 6, 2009
• Last updated: February 29, 2012
• Start date: March 2009
• Est. completion date: September 2010

Study information

• Verified date: February 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1380
• Est. completion date: September 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Insurance Coverage
• Smoking Cessation

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Pfizer Investigational Site	Aylmer	Ontario
Canada	Pfizer Investigational Site	Bay Roberts	Newfoundland and Labrador
Canada	Pfizer Investigational Site	Bolton	Ontario
Canada	Pfizer Investigational Site	Burnaby	British Columbia
Canada	Pfizer Investigational Site	Charlottetown	Prince Edward Island
Canada	Pfizer Investigational Site	Charlottetown	Prince Edward Island
Canada	Pfizer Investigational Site	Chilliwack	British Columbia
Canada	Pfizer Investigational Site	Collingwood	Ontario
Canada	Pfizer Investigational Site	Coquitlam	British Columbia
Canada	Pfizer Investigational Site	Corunna	Ontario
Canada	Pfizer Investigational Site	Hamilton	Ontario
Canada	Pfizer Investigational Site	Hamilton	Ontario
Canada	Pfizer Investigational Site	Kamloops	British Columbia
Canada	Pfizer Investigational Site	Kelowna	British Columbia
Canada	Pfizer Investigational Site	Langley	British Columbia
Canada	Pfizer Investigational Site	London	Ontario
Canada	Pfizer Investigational Site	London	Ontario
Canada	Pfizer Investigational Site	London	Ontario
Canada	Pfizer Investigational Site	London	Ontario
Canada	Pfizer Investigational Site	London	Ontario
Canada	Pfizer Investigational Site	London	Ontario
Canada	Pfizer Investigational Site	London	Ontario
Canada	Pfizer Investigational Site	London	Ontario
Canada	Pfizer Investigational Site	Montague	Prince Edward Island
Canada	Pfizer Investigational Site	Newmarket	Ontario
Canada	Pfizer Investigational Site	North Vancouver	British Columbia
Canada	Pfizer Investigational Site	Ottawa	Ontario
Canada	Pfizer Investigational Site	Paradise	Newfoundland and Labrador
Canada	Pfizer Investigational Site	Penticton	British Columbia
Canada	Pfizer Investigational Site	Regina	Saskatchewan
Canada	Pfizer Investigational Site	Sarnia	Ontario
Canada	Pfizer Investigational Site	Saskatoon	Saskatchewan
Canada	Pfizer Investigational Site	Saskatoon	Saskatchewan
Canada	Pfizer Investigational Site	St. John's	Newfoundland and Labrador
Canada	Pfizer Investigational Site	St. John's	Newfoundland and Labrador
Canada	Pfizer Investigational Site	Stayner	Ontario
Canada	Pfizer Investigational Site	Strathroy	Ontario
Canada	Pfizer Investigational Site	Sydney	Nova Scotia
Canada	Pfizer Investigational Site	Thornhill	Ontario
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Vancouver	British Columbia
Canada	Pfizer Investigational Site	Vancouver	British Columbia
Canada	Pfizer Investigational Site	Victoria	British Columbia
Canada	Pfizer Investigational Site	Windsor	Nova Scotia
Canada	Pfizer Investigational Site	Winnipeg	Manitoba
Canada	Pfizer Investigational Site	Winnipeg	Manitoba
Canada	Pfizer Investigational Site	Winnipeg	Manitoba
Canada	Pfizer Investigational Site	Winnipeg	Manitoba
Canada	Pfizer Investigational Site	Winnipeg	Manitoba
Canada	Pfizer Investigational Site	Winnipeg	Manitoba
Canada	Pfizer Investigational Site	Woodstock	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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?"	Week 26	No
Secondary	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]).	Week 26	No
Secondary	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.	Week 26, Week 39, and Week 52	No
Secondary	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?"	Week 13	No
Secondary	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	Week 26 to Week 52	No

External Links

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