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Randomized Controlled Trial
. 2018 Sep 13;52(10):854-864.
doi: 10.1093/abm/kax059.

A Randomized Controlled Trial of an Optimized Smoking Treatment Delivered in Primary Care

Megan E Piper  1   2 , Jessica W Cook  1   2   3 , Tanya R Schlam  1   2 , Douglas E Jorenby  1   2 , Stevens S Smith  1   2 , Linda M Collins  4   5 , Robin Mermelstein  6 , David Fraser  1 , Michael C Fiore  1   2 , Timothy B Baker  1   2
Affiliations
Randomized Controlled Trial

A Randomized Controlled Trial of an Optimized Smoking Treatment Delivered in Primary Care

Megan E Piper et al. Ann Behav Med. .

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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Figures

Fig. 1
Fig. 1
CONSORT diagram.
Fig. 2
Fig. 2
Mean self-reported 7-day point-prevalence abstinence rates at Weeks 4, 8, 16, 26, 39, and 52, and carbon monoxide (CO)-confirmed point-prevalence abstinence at Week 26 for the recommended usual care and abstinence-optimized treatments.
Fig. 3
Fig. 3
Participant flow for establishing biochemically confirmed abstinence at Week 26.
See this image and copyright information in PMC

References

    1. U.S. Department of Health and Human Services. In: National Center for Chronic Disease Prevention and Health Promotion (US) Office on Smoking and Health. Source, ed. The Health Consequences of Smoking—50 Years of Progress: A Report of the Surgeon General. Atlanta, GA:Centers for Disease Control and Prevention (US)2014.
    1. Centers for Disease Control and Prevention. Current Cigarette Smoking Among Adults in the United States, 2016http://www.cdc.gov/tobacco/data_statistics/fact_sheets/adult_data/cig_sm....Accessibility verified September 15, 2017.
    1. Fiore MC, Jaen CR, Baker TB, et al. . Treating Tobacco Use and Dependence: 2008 Update. Rockville, MD: U.S. Department of Health and Human Services, U.S. Public Health Service; 2008.
    1. Babb S, Malarcher A, Schauer G, Asman K, Jamal A. Quitting smoking among adults – United States, 2000–2015. MMWR Morb Mortal Wkly Rep. 2017;65(52):1457–1464. - PubMed
    1. Stead LF, Koilpillai P, Fanshawe TR, Lancaster T. Combined pharmacotherapy and behavioural interventions for smoking cessation. Cochrane Database Syst Rev. 2016;3:CD008286. - PMC - PubMed

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