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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00818207
First received: January 6, 2009
Last updated: February 29, 2012
Last verified: February 2012

January 6, 2009
February 29, 2012
March 2009
March 2010   (final data collection date for primary outcome measure)
Percentage of Participants With 7-Day Point Prevalence (PP) of Abstinence [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
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?"
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 ]
Complete list of historical versions of study NCT00818207 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With Biochemically Confirmed 7-Day PP Abstinence From Tobacco [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 26, Week 39, and Week 52 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 13 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 26 to Week 52 ] [ Designated as safety issue: No ]
    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
  • 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 ]
Not Provided
Not Provided
 
Impact Of Smoking Cessation Treatment Reimbursement On The Quit Rates In Smokers Motivated To Quit
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Smoking Cessation
  • Insurance Coverage
  • 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.
  • 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%)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1380
September 2010
March 2010   (final data collection date for primary outcome measure)

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).
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00818207
A3051116
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP