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Published in: BMC Public Health 1/2014

Open Access 01-12-2014 | Research article

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)

Authors: Peter Selby, Gerald Brosky, Paul Oh, Vincent Raymond, Carmen Arteaga, Suzanne Ranger

Published in: BMC Public Health | Issue 1/2014

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Abstract

Background

Many smokers find the cost of smoking cessation medications a barrier. Financial coverage for these medications increases utilization of pharmacotherapies. This study assesses whether financial coverage increases the proportion of successful quitters.

Methods

A pragmatic, open-label, randomized, controlled trial was conducted in 58 Canadian sites between March 2009 and September 2010. Smokers (≥10 cigarettes/day) without insurance coverage who were motivated to quit within 14 days were randomized (1:1) in a blinded manner to receive either full coverage eligibility for 26 weeks or no coverage. Pharmacotherapies covered were varenicline, bupropion, or nicotine patches/gum. Investigators/subjects were unblinded to study group assignment after randomization and prior to choosing a smoking cessation method(s). All subjects received brief smoking cessation counseling. The primary outcome measure was self-reported 7-day point prevalence of abstinence (PPA) at week 26.

Results

Of the 1380 randomized subjects (coverage, 696; no coverage, 684), 682 (98.0%) and 435 (63.6%), respectively, were dispensed at least one smoking cessation medication dose. The 7-day PPA at week 26 was higher in the full coverage versus no coverage group: 20.8% (n = 145) and 13.9% (n = 95), respectively; odds ratio (OR) = 1.64, 95% confidence interval (CI) 1.23–2.18; p = 0.001. Urine cotinine-confirmed 7-day PPA at week 26 was 15.7% (n = 109) and 10.1% (n = 69), respectively; OR = 1.68, 95% CI 1.21–2.33; p = 0.002. After pharmacotherapy, coverage eligibility was withdrawn from the full coverage group, continuous abstinence between weeks 26 and 52 was 6.6% (n = 46) and 5.6% (n = 38), in the full coverage and no coverage groups, respectively; OR = 1.19, 95% CI 0.76–1.87; p = 0.439.

Conclusions

In this study, the adoption of a smoking cessation medication coverage drug policy was an effective intervention to improve 26-week quit rates in Canada. The advantages were lost once coverage was discontinued. Further study is required on the duration of coverage to prevent relapse to smoking. (clinicaltrials.gov identifier: NCT00818207; the study was sponsored by Pfizer Inc.).
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Literature
2.
go back to reference Stead LF, Perera R, Bullen C, Mant D, Lancaster T: Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2008, 1: CD000146 Stead LF, Perera R, Bullen C, Mant D, Lancaster T: Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2008, 1: CD000146
3.
go back to reference Hughes JR, Stead LF, Lancaster T: Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2007, 1: CD000031 Hughes JR, Stead LF, Lancaster T: Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2007, 1: CD000031
4.
go back to reference Cahill K, Stead LF, Lancaster T: Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2012, 4: CD006103 Cahill K, Stead LF, Lancaster T: Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2012, 4: CD006103
6.
go back to reference Eisenberg MJ, Filion KB, Yavin D, Bélisle P, Mottillo S, Joseph L, Gervais A, O'Loughlin J, Paradis G, Rinfret S, Pilote L: Pharmacotherapies for smoking cessation: a meta-analysis of randomized controlled trials. CMAJ. 2008, 179 (2): 135-144. 10.1503/cmaj.070256.CrossRefPubMedPubMedCentral Eisenberg MJ, Filion KB, Yavin D, Bélisle P, Mottillo S, Joseph L, Gervais A, O'Loughlin J, Paradis G, Rinfret S, Pilote L: Pharmacotherapies for smoking cessation: a meta-analysis of randomized controlled trials. CMAJ. 2008, 179 (2): 135-144. 10.1503/cmaj.070256.CrossRefPubMedPubMedCentral
7.
go back to reference Le Foll B, George TP: Treatment of tobacco dependence: integrating recent progress into practice. CMAJ. 2007, 177 (11): 1373-1380. 10.1503/cmaj.070627.CrossRefPubMedPubMedCentral Le Foll B, George TP: Treatment of tobacco dependence: integrating recent progress into practice. CMAJ. 2007, 177 (11): 1373-1380. 10.1503/cmaj.070627.CrossRefPubMedPubMedCentral
9.
go back to reference Reda AA, Kotz D, Evers SM, van Schayck CP: Healthcare financing systems for increasing the use of tobacco dependence treatment. Cochrane Database Syst Rev. 2012, 6: CD004305 Reda AA, Kotz D, Evers SM, van Schayck CP: Healthcare financing systems for increasing the use of tobacco dependence treatment. Cochrane Database Syst Rev. 2012, 6: CD004305
10.
go back to reference Le Strat Y, Rehm J, Le Foll B: How generalisable to community samples are clinical trial results for treatment of nicotine dependence: a comparison of common eligibility criteria with respondents of a large representative general population survey. Tob Control. 2011, 20 (5): 338-343. 10.1136/tc.2010.038703.CrossRefPubMed Le Strat Y, Rehm J, Le Foll B: How generalisable to community samples are clinical trial results for treatment of nicotine dependence: a comparison of common eligibility criteria with respondents of a large representative general population survey. Tob Control. 2011, 20 (5): 338-343. 10.1136/tc.2010.038703.CrossRefPubMed
11.
go back to reference Selby P, Brosky G, Oh P, Raymond V, Ranger S: How pragmatic or explanatory is the randomized, controlled trial? The application and enhancement of the PRECIS tool to the evaluation of a smoking cessation trial. BMC Med Res Methodol. 2012, 12: 101-10.1186/1471-2288-12-101.CrossRefPubMedPubMedCentral Selby P, Brosky G, Oh P, Raymond V, Ranger S: How pragmatic or explanatory is the randomized, controlled trial? The application and enhancement of the PRECIS tool to the evaluation of a smoking cessation trial. BMC Med Res Methodol. 2012, 12: 101-10.1186/1471-2288-12-101.CrossRefPubMedPubMedCentral
12.
go back to reference Thorpe KE, Zwarenstein M, Oxman AD, Treweek S, Furberg CD, Altman DG, Tunis S, Bergel E, Harvey I, Magid DJ, Chalkidou K: A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. CMAJ. 2009, 180 (10): E47-E57. 10.1503/cmaj.090523.CrossRefPubMedPubMedCentral Thorpe KE, Zwarenstein M, Oxman AD, Treweek S, Furberg CD, Altman DG, Tunis S, Bergel E, Harvey I, Magid DJ, Chalkidou K: A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. CMAJ. 2009, 180 (10): E47-E57. 10.1503/cmaj.090523.CrossRefPubMedPubMedCentral
13.
go back to reference Fagerstrom KO, Heatherton TF, Kozlowski LT: Nicotine addiction and its assessment. Ear Nose Throat J. 1990, 69 (11): 763-765.PubMed Fagerstrom KO, Heatherton TF, Kozlowski LT: Nicotine addiction and its assessment. Ear Nose Throat J. 1990, 69 (11): 763-765.PubMed
14.
go back to reference Heatherton TF, Kozlowski LT, Frecker RC, Fagerström KO: The Fagerström Test for Nicotine Dependence: a revision of the Fagerström Tolerance Questionnaire. Br J Addict. 1991, 86 (9): 1119-1127. 10.1111/j.1360-0443.1991.tb01879.x.CrossRefPubMed Heatherton TF, Kozlowski LT, Frecker RC, Fagerström KO: The Fagerström Test for Nicotine Dependence: a revision of the Fagerström Tolerance Questionnaire. Br J Addict. 1991, 86 (9): 1119-1127. 10.1111/j.1360-0443.1991.tb01879.x.CrossRefPubMed
15.
go back to reference Posner K, Oquendo MA, Gould M, Stanley B, Davies M: Columbia Classification Algorithm of Suicide Assessment (C-CASA): classification of suicidal events in the FDA's pediatric suicidal risk analysis of antidepressants. A J Psychiatry. 2007, 164 (7): 1035-1043. 10.1176/appi.ajp.164.7.1035.CrossRef Posner K, Oquendo MA, Gould M, Stanley B, Davies M: Columbia Classification Algorithm of Suicide Assessment (C-CASA): classification of suicidal events in the FDA's pediatric suicidal risk analysis of antidepressants. A J Psychiatry. 2007, 164 (7): 1035-1043. 10.1176/appi.ajp.164.7.1035.CrossRef
16.
go back to reference Fiore FC, Jaén CR, Baker TB, Bailey WC, Benowitz NL, Curry SJ: Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. 2008, Rockville, MD: U.S. Department of Health and Human Services Public Health Service Fiore FC, Jaén CR, Baker TB, Bailey WC, Benowitz NL, Curry SJ: Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. 2008, Rockville, MD: U.S. Department of Health and Human Services Public Health Service
17.
go back to reference Hughes JR, Keely JP, Niaura RS, Ossip-Klein DJ, Richmond RL, Swan GE: Measures of abstinence in clinical trials: issues and recommendations. Nicotine Tob Res. 2003, 5 (1): 13-25. 10.1093/ntr/5.1.13.CrossRefPubMed Hughes JR, Keely JP, Niaura RS, Ossip-Klein DJ, Richmond RL, Swan GE: Measures of abstinence in clinical trials: issues and recommendations. Nicotine Tob Res. 2003, 5 (1): 13-25. 10.1093/ntr/5.1.13.CrossRefPubMed
18.
go back to reference Wong SL, Shields M, Leatherdale S, Malaison E, Hammond D: Assessment of validity of self-reported smoking status. Health Rep. 2012, 23 (1): 47-53.PubMed Wong SL, Shields M, Leatherdale S, Malaison E, Hammond D: Assessment of validity of self-reported smoking status. Health Rep. 2012, 23 (1): 47-53.PubMed
19.
go back to reference Gonzales D, Rennard SI, Nides M, Oncken C, Azoulay S, Billing CB, Watsky EJ, Gong J, Williams KE, Reeves KR: Varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs sustained-release bupropion and placebo for smoking cessation: a randomized controlled trial. JAMA. 2006, 296 (1): 47-55. 10.1001/jama.296.1.47.CrossRefPubMed Gonzales D, Rennard SI, Nides M, Oncken C, Azoulay S, Billing CB, Watsky EJ, Gong J, Williams KE, Reeves KR: Varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs sustained-release bupropion and placebo for smoking cessation: a randomized controlled trial. JAMA. 2006, 296 (1): 47-55. 10.1001/jama.296.1.47.CrossRefPubMed
20.
go back to reference Jorenby DE, Hays JT, Rigotti NA, Azoulay S, Watsky EJ, Williams KE, Billing CB, Gong J, Reeves KR: Efficacy of varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation: a randomized controlled trial. JAMA. 2006, 296 (1): 56-63. 10.1001/jama.296.1.56.CrossRefPubMed Jorenby DE, Hays JT, Rigotti NA, Azoulay S, Watsky EJ, Williams KE, Billing CB, Gong J, Reeves KR: Efficacy of varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation: a randomized controlled trial. JAMA. 2006, 296 (1): 56-63. 10.1001/jama.296.1.56.CrossRefPubMed
21.
go back to reference Kaper J, Wagena EJ, Severens JL, Van Schayck CP: Healthcare financing systems for increasing the use of tobacco dependence treatment. Cochrane Database Syst Rev. 2005, 1: CD004305 Kaper J, Wagena EJ, Severens JL, Van Schayck CP: Healthcare financing systems for increasing the use of tobacco dependence treatment. Cochrane Database Syst Rev. 2005, 1: CD004305
22.
go back to reference Kaper J, Wagena EJ, Willemsen MC, van Schayck CP: A randomized controlled trial to assess the effects of reimbursing the costs of smoking cessation therapy on sustained abstinence. Addiction. 2006, 101 (11): 1656-1661. 10.1111/j.1360-0443.2006.01578.x.CrossRefPubMed Kaper J, Wagena EJ, Willemsen MC, van Schayck CP: A randomized controlled trial to assess the effects of reimbursing the costs of smoking cessation therapy on sustained abstinence. Addiction. 2006, 101 (11): 1656-1661. 10.1111/j.1360-0443.2006.01578.x.CrossRefPubMed
23.
go back to reference Hughes JR, Keely J, Naud S: Shape of the relapse curve and long-term abstinence among untreated smokers. Addiction. 2004, 99 (1): 29-38. 10.1111/j.1360-0443.2004.00540.x.CrossRefPubMed Hughes JR, Keely J, Naud S: Shape of the relapse curve and long-term abstinence among untreated smokers. Addiction. 2004, 99 (1): 29-38. 10.1111/j.1360-0443.2004.00540.x.CrossRefPubMed
24.
go back to reference Kaper J, Wagena EJ, Willemsen MC, van Schayck CP: Reimbursement for smoking cessation treatment may double the abstinence rate: results of a randomized trial. Addiction. 2005, 100 (7): 1012-1020. 10.1111/j.1360-0443.2005.01097.x.CrossRefPubMed Kaper J, Wagena EJ, Willemsen MC, van Schayck CP: Reimbursement for smoking cessation treatment may double the abstinence rate: results of a randomized trial. Addiction. 2005, 100 (7): 1012-1020. 10.1111/j.1360-0443.2005.01097.x.CrossRefPubMed
25.
go back to reference West R: The clinical significance of "small" effects of smoking cessation treatments. Addiction. 2007, 102 (4): 506-509.CrossRefPubMed West R: The clinical significance of "small" effects of smoking cessation treatments. Addiction. 2007, 102 (4): 506-509.CrossRefPubMed
26.
go back to reference Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D: Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008, 337: a2390-10.1136/bmj.a2390.CrossRefPubMedPubMedCentral Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D: Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008, 337: a2390-10.1136/bmj.a2390.CrossRefPubMedPubMedCentral
27.
go back to reference Schauffler HH, McMenamin S, Olson K, Boyce-Smith G, Rideout JA, Kamil J: Variations in treatment benefits influence smoking cessation: results of a randomised controlled trial. Tob Control. 2001, 10 (2): 175-180. 10.1136/tc.10.2.175.CrossRefPubMedPubMedCentral Schauffler HH, McMenamin S, Olson K, Boyce-Smith G, Rideout JA, Kamil J: Variations in treatment benefits influence smoking cessation: results of a randomised controlled trial. Tob Control. 2001, 10 (2): 175-180. 10.1136/tc.10.2.175.CrossRefPubMedPubMedCentral
28.
go back to reference Baker TB, Mermelstein R, Collins LM, Piper ME, Jorenby DE, Smith SS, Christiansen BA, Schlam TR, Cook JW, Fiore MC: New methods for tobacco dependence treatment research. Ann Behav Med. 2011, 41 (2): 192-207. 10.1007/s12160-010-9252-y.CrossRefPubMedPubMedCentral Baker TB, Mermelstein R, Collins LM, Piper ME, Jorenby DE, Smith SS, Christiansen BA, Schlam TR, Cook JW, Fiore MC: New methods for tobacco dependence treatment research. Ann Behav Med. 2011, 41 (2): 192-207. 10.1007/s12160-010-9252-y.CrossRefPubMedPubMedCentral
Metadata
Title
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)
Authors
Peter Selby
Gerald Brosky
Paul Oh
Vincent Raymond
Carmen Arteaga
Suzanne Ranger
Publication date
01-12-2014
Publisher
BioMed Central
Published in
BMC Public Health / Issue 1/2014
Electronic ISSN: 1471-2458
DOI
https://doi.org/10.1186/1471-2458-14-433

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