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

NCT00818207 | Completed Phase 4 Results

• 1 other identifier: A3051116
• Study Type: interventional
• Target: 1,380
• Locations: 1 country
• Sites: 56

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.

Conditions

Smoking Cessation; Insurance Coverage

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  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?"

  Week 26

Secondary Outcomes (4)

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

  Week 26

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

  Week 26, Week 39, and Week 52

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

  Week 13

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

  Week 26 to Week 52

Study Arms (2)

Full Smoking Cessation Treatment Coverage (100%)

OTHER

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%)

No Smoking Cessation Treatment Coverage (0%)

OTHER

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%)

Interventions

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.

Full Smoking Cessation Treatment Coverage (100%)

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.

No Smoking Cessation Treatment Coverage (0%)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (56)

Pfizer Investigational Site

Burnaby, British Columbia, V5G 1T4, Canada

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Chilliwack, British Columbia, V2P 4M9, Canada

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Coquitlam, British Columbia, V3K 3P4, Canada

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Kamloops, British Columbia, V2C 1K7, Canada

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Kelowna, British Columbia, V1Y 3G8, Canada

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Langley, British Columbia, V3A 4H9, Canada

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North Vancouver, British Columbia, V7N 4M2, Canada

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Penticton, British Columbia, V2A 5C8, Canada

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Vancouver, British Columbia, V5K 1K3, Canada

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Vancouver, British Columbia, V5Z 1M9, Canada

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Victoria, British Columbia, V8R 1J8, Canada

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Winnipeg, Manitoba, R2H 2A6, Canada

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Winnipeg, Manitoba, R2M 3T2, Canada

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Winnipeg, Manitoba, R2V 4W3, Canada

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Winnipeg, Manitoba, R3A 1R9, Canada

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Winnipeg, Manitoba, R3C 0N2, Canada

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Winnipeg, Manitoba, R3E 3P4, Canada

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Bay Roberts, Newfoundland and Labrador, A0A 1G0, Canada

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Paradise, Newfoundland and Labrador, A1L 1C6, Canada

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St. John's, Newfoundland and Labrador, A1A 3R5, Canada

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St. John's, Newfoundland and Labrador, A1E 2E2, Canada

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Sydney, Nova Scotia, B1P 1C6, Canada

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Windsor, Nova Scotia, B0N 2T0, Canada

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Aylmer, Ontario, N5H 1K9, Canada

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Bolton, Ontario, L7E 1E8, Canada

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Collingwood, Ontario, L9Y 1W3, Canada

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Corunna, Ontario, N0N 1G0, Canada

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Hamilton, Ontario, L8M 1K7, Canada

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Hamilton, Ontario, L8N 4A6, Canada

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London, Ontario, N5W 3C6, Canada

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London, Ontario, N5W 6A2, Canada

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London, Ontario, N5Y 5K7, Canada

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London, Ontario, N6A 5G6, Canada

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London, Ontario, N6A 5W9, Canada

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London, Ontario, N6C 4Y7, Canada

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London, Ontario, N6H 4P2, Canada

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London, Ontario, N6P 1A9, Canada

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Newmarket, Ontario, L3Y 5G8, Canada

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Ottawa, Ontario, K2C 3R2, Canada

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Sarnia, Ontario, N7T 4X3, Canada

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Stayner, Ontario, L0M 1S0, Canada

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Strathroy, Ontario, N7G 1Y7, Canada

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Thornhill, Ontario, L4J 6W6, Canada

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Toronto, Ontario, M3H 5S4, Canada

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Toronto, Ontario, M5G 1N8, Canada

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Toronto, Ontario, M6L 3C9, Canada

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Toronto, Ontario, M8V 3X8, Canada

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Toronto, Ontario, M9V 4B4, Canada

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Toronto, Ontario, M9W 4L6, Canada

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Woodstock, Ontario, N4S 5P5, Canada

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Charlottetown, Prince Edward Island, C1A 1L2, Canada

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Charlottetown, Prince Edward Island, C1A 5Y9, Canada

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Montague, Prince Edward Island, C0A 1R0, Canada

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Regina, Saskatchewan, S4P 3X1, Canada

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Saskatoon, Saskatchewan, S7K 6Y6, Canada

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Saskatoon, Saskatchewan, S7K 7H9, Canada

Location

Related Publications (1)

• Selby P, Brosky G, Oh P, Raymond V, Arteaga C, Ranger S. A pragmatic, randomized, controlled study evaluating the impact of access to smoking cessation pharmacotherapy coverage on the proportion of successful quitters in a Canadian population of smokers motivated to quit (ACCESSATION). BMC Public Health. 2014 May 7;14:433. doi: 10.1186/1471-2458-14-433.

  PMID: 24885542 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2009
• First Posted: January 7, 2009
• Study Start: March 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: September 1, 2010
• Last Updated: March 30, 2012
• Results First Posted: March 30, 2012

Record last verified: 2012-02

Locations

CA (56)