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

Phase 4

Completed

Conditions: Smoking Cessation
Insurance Coverage

Interventions: Other: Full Smoking Cessation Treatment Coverage (100%)
Other: No Smoking Cessation Treatment Coverage (0%)

Registration Number: NCT00818207

Lead Sponsor: Pfizer

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1380

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Full Smoking Cessation Treatment Coverage (100%)	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.
No Smoking Cessation Treatment Coverage (0%)	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With 7-Day Point Prevalence (PP) of Abstinence	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?"

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Biochemically Confirmed 7-Day PP Abstinence From Tobacco	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 \[ng/mL\]).
Percentage of Participants With Continuous Abstinence (CA) at Weeks 26, 39, and 52	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.
Percentage of Participants With 7-Day PP of Abstinence at Week 13	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?"
Percentage of Participants With Long Term Quit Rate (LTQR) Through Weeks 26 to 52	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