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
  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
Smoking Cessation
Insurance Coverage
Other: Full Smoking Cessation Treatment Coverage (100%)
Other: No Smoking Cessation Treatment Coverage (0%)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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?"


Secondary Outcome Measures:
  • 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


Enrollment: 1380
Study Start Date: March 2009
Study Completion Date: September 2010
Primary Completion Date: March 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 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 56 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00818207     History of Changes
Other Study ID Numbers: A3051116
Study First Received: January 6, 2009
Results First Received: February 29, 2012
Last Updated: February 29, 2012
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.

ClinicalTrials.gov processed this record on October 19, 2014