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Completed

NCT Number: NCT00818207

Impact Of Smoking Cessation Treatment Reimbursement On The Quit Rates In 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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior Insurance Coverage

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Burnaby, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Full Smoking Cessation Treatment Coverage (100%)

Other

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%)

Other

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.

Primary outcomes

  1. Percentage of Participants With 7-Day Point Prevalence (PP) of Abstinence

    Time frame: 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 outcomes

  1. Percentage of Participants With Biochemically Confirmed 7-Day PP Abstinence From Tobacco

    Time frame: 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]).

  2. Percentage of Participants With Continuous Abstinence (CA) at Weeks 26, 39, and 52

    Time frame: 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.

  3. Percentage of Participants With 7-Day PP of Abstinence at Week 13

    Time frame: 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?"

  4. Percentage of Participants With Long Term Quit Rate (LTQR) Through Weeks 26 to 52

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Acronym: ACCESSATION

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 7, 2009
Registry last updated
Mar 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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