Clinical trial NCT00818207: Impact Of Smoking Cessation Treatment Reimbursement On The Quit Rates In Smokers Motivated To Quit
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking Cessation
Insurance Coverage
Keywords: Smoking cessation
quit rates
reimbursement
drug coverage
effectiveness
cost-effectiveness
health policy
drug utilization
adherence
urine cotinine.
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-01-07
Enrollment: 1380
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Percentage of Participants With 7-Day Point Prevalence (PP) of Abstinence
timeFrame: Week 26
Secondary outcomes:
measure: Percentage of Participants With Biochemically Confirmed 7-Day PP Abstinence From Tobacco
timeFrame: Week 26
measure: Percentage of Participants With Continuous Abstinence (CA) at Weeks 26, 39, and 52
timeFrame: Week 26, Week 39, and Week 52
measure: Percentage of Participants With 7-Day PP of Abstinence at Week 13
timeFrame: Week 13
measure: Percentage of Participants With Long Term Quit Rate (LTQR) Through Weeks 26 to 52
timeFrame: Week 26 to Week 52
Other outcomes:
Locations:
city: Burnaby
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Chilliwack
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Coquitlam
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Kamloops
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Kelowna
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Langley
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: North Vancouver
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Penticton
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Victoria
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Bay Roberts
country: Canada
facility: Pfizer Investigational Site
state: Newfoundland and Labrador
city: Paradise
country: Canada
facility: Pfizer Investigational Site
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: Pfizer Investigational Site
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: Pfizer Investigational Site
state: Newfoundland and Labrador
city: Sydney
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Windsor
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Aylmer
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Bolton
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Collingwood
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Corunna
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Newmarket
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Sarnia
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Stayner
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Strathroy
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Thornhill
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Woodstock
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Charlottetown
country: Canada
facility: Pfizer Investigational Site
state: Prince Edward Island
city: Charlottetown
country: Canada
facility: Pfizer Investigational Site
state: Prince Edward Island
city: Montague
country: Canada
facility: Pfizer Investigational Site
state: Prince Edward Island
city: Regina
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.