A randomized controlled trial of an optimized smoking treatment delivered in primary care

Megan E. Piper, Jessica W. Cook, Tanya R. Schlam, Douglas E. Jorenby, Stevens S. Smith, Linda Marie Collins, Robin Mermelstein, David Fraser, Michael C. Fiore, Timothy B. Baker

Research output: Contribution to journalArticle

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Abstract

Background The effectiveness of smoking cessation treatment is limited in real-world use, perhaps because we have not selected the components of such treatments optimally nor have treatments typically been developed for and evaluated in real-world clinical settings. Purpose To validate an optimized smoking cessation treatment package that comprises intervention components identified as effective in factorial screening experiments conducted as per the Multiphase Optimization Strategy (MOST). Methods Adult smokers motivated to quit were recruited from primary care clinics (N = 623). Participants were randomized to receive either recommended usual care (R-UC; 10 min of in-person counseling, 8 weeks of nicotine patch, and referral to quitline services) or abstinence-optimized treatment (A-OT; 3 weeks of prequit mini-lozenges, 26 weeks of nicotine patch + mini-lozenges, three in-person and eight phone counseling sessions, and 7-11 automated calls to prompt medication use). The key outcomes were self-reported and biochemically confirmed (carbon monoxide, CO <6 ppm) 7-day point-prevalence abstinence. Results A-OT participants had significantly higher self-reported abstinence rates than R-UC participants at 4, 8, 16, and 26 weeks (ORs: 1.91-3.05; p <. 001). The biochemically confirmed 26-week abstinence rates were lower than the self-reported 26-week rates, but revealed a similar treatment effect size (OR = 2.94, p < .001). There was no moderation of treatment effects on 26-week abstinence by demographic, psychiatric, or nicotine dependence variables. A-OT had an incremental cost-effectiveness ratio for 26-week CO-confirmed abstinence of $7,800. Conclusions A smoking cessation treatment that is optimized via MOST development meaningfully enhances cessation rates beyond R-UC smoking treatment in smokers seen in primary care. Clinical Trial Registration NCT02301403.

Original languageEnglish (US)
Pages (from-to)854-864
Number of pages11
JournalAnnals of Behavioral Medicine
Volume52
Issue number10
DOIs
StatePublished - Sep 13 2018

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Primary Health Care
Randomized Controlled Trials
Smoking
Withholding Treatment
Smoking Cessation
Carbon Monoxide
Tobacco Use Cessation Products
Counseling
Therapeutics
Tobacco Use Disorder
Cost-Benefit Analysis
Psychiatry
Referral and Consultation
Demography
Clinical Trials

All Science Journal Classification (ASJC) codes

  • Psychology(all)
  • Psychiatry and Mental health

Cite this

Piper, M. E., Cook, J. W., Schlam, T. R., Jorenby, D. E., Smith, S. S., Collins, L. M., ... Baker, T. B. (2018). A randomized controlled trial of an optimized smoking treatment delivered in primary care. Annals of Behavioral Medicine, 52(10), 854-864. https://doi.org/10.1093/abm/kax059
Piper, Megan E. ; Cook, Jessica W. ; Schlam, Tanya R. ; Jorenby, Douglas E. ; Smith, Stevens S. ; Collins, Linda Marie ; Mermelstein, Robin ; Fraser, David ; Fiore, Michael C. ; Baker, Timothy B. / A randomized controlled trial of an optimized smoking treatment delivered in primary care. In: Annals of Behavioral Medicine. 2018 ; Vol. 52, No. 10. pp. 854-864.
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abstract = "Background The effectiveness of smoking cessation treatment is limited in real-world use, perhaps because we have not selected the components of such treatments optimally nor have treatments typically been developed for and evaluated in real-world clinical settings. Purpose To validate an optimized smoking cessation treatment package that comprises intervention components identified as effective in factorial screening experiments conducted as per the Multiphase Optimization Strategy (MOST). Methods Adult smokers motivated to quit were recruited from primary care clinics (N = 623). Participants were randomized to receive either recommended usual care (R-UC; 10 min of in-person counseling, 8 weeks of nicotine patch, and referral to quitline services) or abstinence-optimized treatment (A-OT; 3 weeks of prequit mini-lozenges, 26 weeks of nicotine patch + mini-lozenges, three in-person and eight phone counseling sessions, and 7-11 automated calls to prompt medication use). The key outcomes were self-reported and biochemically confirmed (carbon monoxide, CO <6 ppm) 7-day point-prevalence abstinence. Results A-OT participants had significantly higher self-reported abstinence rates than R-UC participants at 4, 8, 16, and 26 weeks (ORs: 1.91-3.05; p <. 001). The biochemically confirmed 26-week abstinence rates were lower than the self-reported 26-week rates, but revealed a similar treatment effect size (OR = 2.94, p < .001). There was no moderation of treatment effects on 26-week abstinence by demographic, psychiatric, or nicotine dependence variables. A-OT had an incremental cost-effectiveness ratio for 26-week CO-confirmed abstinence of $7,800. Conclusions A smoking cessation treatment that is optimized via MOST development meaningfully enhances cessation rates beyond R-UC smoking treatment in smokers seen in primary care. Clinical Trial Registration NCT02301403.",
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Piper, ME, Cook, JW, Schlam, TR, Jorenby, DE, Smith, SS, Collins, LM, Mermelstein, R, Fraser, D, Fiore, MC & Baker, TB 2018, 'A randomized controlled trial of an optimized smoking treatment delivered in primary care', Annals of Behavioral Medicine, vol. 52, no. 10, pp. 854-864. https://doi.org/10.1093/abm/kax059

A randomized controlled trial of an optimized smoking treatment delivered in primary care. / Piper, Megan E.; Cook, Jessica W.; Schlam, Tanya R.; Jorenby, Douglas E.; Smith, Stevens S.; Collins, Linda Marie; Mermelstein, Robin; Fraser, David; Fiore, Michael C.; Baker, Timothy B.

In: Annals of Behavioral Medicine, Vol. 52, No. 10, 13.09.2018, p. 854-864.

Research output: Contribution to journalArticle

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T1 - A randomized controlled trial of an optimized smoking treatment delivered in primary care

AU - Piper, Megan E.

AU - Cook, Jessica W.

AU - Schlam, Tanya R.

AU - Jorenby, Douglas E.

AU - Smith, Stevens S.

AU - Collins, Linda Marie

AU - Mermelstein, Robin

AU - Fraser, David

AU - Fiore, Michael C.

AU - Baker, Timothy B.

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N2 - Background The effectiveness of smoking cessation treatment is limited in real-world use, perhaps because we have not selected the components of such treatments optimally nor have treatments typically been developed for and evaluated in real-world clinical settings. Purpose To validate an optimized smoking cessation treatment package that comprises intervention components identified as effective in factorial screening experiments conducted as per the Multiphase Optimization Strategy (MOST). Methods Adult smokers motivated to quit were recruited from primary care clinics (N = 623). Participants were randomized to receive either recommended usual care (R-UC; 10 min of in-person counseling, 8 weeks of nicotine patch, and referral to quitline services) or abstinence-optimized treatment (A-OT; 3 weeks of prequit mini-lozenges, 26 weeks of nicotine patch + mini-lozenges, three in-person and eight phone counseling sessions, and 7-11 automated calls to prompt medication use). The key outcomes were self-reported and biochemically confirmed (carbon monoxide, CO <6 ppm) 7-day point-prevalence abstinence. Results A-OT participants had significantly higher self-reported abstinence rates than R-UC participants at 4, 8, 16, and 26 weeks (ORs: 1.91-3.05; p <. 001). The biochemically confirmed 26-week abstinence rates were lower than the self-reported 26-week rates, but revealed a similar treatment effect size (OR = 2.94, p < .001). There was no moderation of treatment effects on 26-week abstinence by demographic, psychiatric, or nicotine dependence variables. A-OT had an incremental cost-effectiveness ratio for 26-week CO-confirmed abstinence of $7,800. Conclusions A smoking cessation treatment that is optimized via MOST development meaningfully enhances cessation rates beyond R-UC smoking treatment in smokers seen in primary care. Clinical Trial Registration NCT02301403.

AB - Background The effectiveness of smoking cessation treatment is limited in real-world use, perhaps because we have not selected the components of such treatments optimally nor have treatments typically been developed for and evaluated in real-world clinical settings. Purpose To validate an optimized smoking cessation treatment package that comprises intervention components identified as effective in factorial screening experiments conducted as per the Multiphase Optimization Strategy (MOST). Methods Adult smokers motivated to quit were recruited from primary care clinics (N = 623). Participants were randomized to receive either recommended usual care (R-UC; 10 min of in-person counseling, 8 weeks of nicotine patch, and referral to quitline services) or abstinence-optimized treatment (A-OT; 3 weeks of prequit mini-lozenges, 26 weeks of nicotine patch + mini-lozenges, three in-person and eight phone counseling sessions, and 7-11 automated calls to prompt medication use). The key outcomes were self-reported and biochemically confirmed (carbon monoxide, CO <6 ppm) 7-day point-prevalence abstinence. Results A-OT participants had significantly higher self-reported abstinence rates than R-UC participants at 4, 8, 16, and 26 weeks (ORs: 1.91-3.05; p <. 001). The biochemically confirmed 26-week abstinence rates were lower than the self-reported 26-week rates, but revealed a similar treatment effect size (OR = 2.94, p < .001). There was no moderation of treatment effects on 26-week abstinence by demographic, psychiatric, or nicotine dependence variables. A-OT had an incremental cost-effectiveness ratio for 26-week CO-confirmed abstinence of $7,800. Conclusions A smoking cessation treatment that is optimized via MOST development meaningfully enhances cessation rates beyond R-UC smoking treatment in smokers seen in primary care. Clinical Trial Registration NCT02301403.

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