Impact Of Smoking Cessation Treatment Reimbursement On The Quit Rates In Smokers Motivated To Quit - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00818207

Purpose

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.

Condition	Intervention	Phase
Insurance Coverage Smoking Cessation	Other: Full Smoking Cessation Treatment Coverage (100%) Other: No Smoking Cessation Treatment Coverage (0%)	Phase IV

MedlinePlus related topics: Quitting Smoking Smoking Urine and Urination

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Open Label, Parallel Assignment, Randomized
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

Further study details as provided by Pfizer:

Primary Outcome Measures:

Self-reported seven-day point prevalence of abstinence at the end of the 26 week reimbursement period (ie, 26 weeks after subject randomization). [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Self-reported seven-day point prevalence of abstinence at the end of the 26 week reimbursement period (ie, 26 weeks after subject randomization), confirmed by urine cotinine test at Week 26 [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Self-reported continuous abstinence (not a single puff) between weeks 25 and 52 (ie, in the 26 weeks following the end of the SCT reimbursement eligibility period), confirmed by urine cotinine tests at Weeks 26, 39, and 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Self-reported continuous abstinence (not a single puff) between weeks 25 and 39 (ie, in the three months following the end of the SCT reimbursement eligibility period), confirmed by urine cotinine tests at Weeks 26 and 39 [ Time Frame: 39 weeks ] [ Designated as safety issue: No ]
Self-reported seven-day point prevalence of abstinence at Week 13 (ie, 13 weeks after subject randomization in the study) [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
Long-term quit rate through Weeks 26 to 52 (defined as the proportion of subjects who have self-reportedly quit at Week 26 and who have had no more than six days of smoking between Weeks 26 and 52) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	1352
Study Start Date:	March 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.
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 subjected 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.

Arms

Assigned Interventions

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.

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 subjected 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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00818207

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Locations

Canada, Newfoundland and Labrador
Pfizer Investigational Site
Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3051116
Study First Received:	January 6, 2009
Last Updated:	February 25, 2009
ClinicalTrials.gov Identifier:	NCT00818207 History of Changes
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Pfizer:

Smoking cessation, quit rates, reimbursement, drug coverage, effectiveness, cost-effectiveness, health policy, drug utilization, adherence, urine cotinine.

Study placed in the following topic categories:

Nicotine polacrilex
Smoking
Nicotine
Bupropion

Additional relevant MeSH terms:

Habits
Smoking

ClinicalTrials.gov processed this record on March 13, 2009