Randomized Controlled Trial

. 2024 Oct:145:107662.

doi: 10.1016/j.cct.2024.107662. Epub 2024 Aug 12.

Predictors of attrition in a randomized controlled trial of an electronic nicotine delivery system among people interested in cigarette smoking reduction

Collaborators, Affiliations

Collaborators

Randomized Control Trial Methods Workgroup of the Center for the Study of Tobacco Products: Member List:
Thomas Eissenberg⁹, Caroline O Cobb⁹, Phoebe Brosnan⁹, Nadia Chowdhury⁹, Jacob T Graham⁹, Alexa A Lopez⁹, Miao-Shan Yen⁹, Le Kang⁹, Shumei Sun⁹, Thokozeni Lipato⁹, Jonathan Foulds¹⁰, Erin Hammett¹⁰, Sharilee Hrabovsky¹⁰, Breianna L Hummer¹⁰, Courtney Lester¹⁰, John P Richie Jr¹⁰, Susan Veldheer¹⁰, Jessica M Yingst¹⁰, Christopher Sciamanna¹⁰, Sophia I Allen¹⁰, Christopher Bullen¹¹

Affiliations

¹ Department of Psychology, Virginia Commonwealth University, 612 N Lombardy St, Richmond, VA 23284, USA; Center for the Study of Tobacco Products, Virginia Commonwealth University, 100 West Franklin Street, Suite 200, Richmond, VA 23220, USA. Electronic address: cobbco@vcu.edu.
² Department of Biostatistics, Virginia Commonwealth University, One Capital Square 830 East Main Street, Richmond, VA 23219, USA.
³ Department of Psychology, Virginia Commonwealth University, 612 N Lombardy St, Richmond, VA 23284, USA; Center for the Study of Tobacco Products, Virginia Commonwealth University, 100 West Franklin Street, Suite 200, Richmond, VA 23220, USA.
⁴ Center for Research on Tobacco and Health, Penn State University College of Medicine, 30 Long Lane, Hershey, PA 17036, USA; Penn State University College of Medicine, Department of Public Health Sciences, 700 HMC Crescent Road, Hershey, PA 17033, USA.
⁵ Center for the Study of Tobacco Products, Virginia Commonwealth University, 100 West Franklin Street, Suite 200, Richmond, VA 23220, USA; Department of Biostatistics, Virginia Commonwealth University, One Capital Square 830 East Main Street, Richmond, VA 23219, USA.
⁶ Boston University, Department of Psychological and Brain Sciences, 64 Cummington Mall #149, Boston, MA 02215, USA.
⁷ NYU Langone Health, 550 First Avenue, New York, NY 10016, USA.
⁸ Department of Health, Behavior and Society, Institute for Global Tobacco Control, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
⁹ Virginia Commonwealth University, United States.
¹⁰ Penn State University, United States.
¹¹ The University of Auckland, New Zealand.

PMID: 39142511
PMCID: PMC11492368
DOI: 10.1016/j.cct.2024.107662

Randomized Controlled Trial

Predictors of attrition in a randomized controlled trial of an electronic nicotine delivery system among people interested in cigarette smoking reduction

Caroline O Cobb et al. Contemp Clin Trials. 2024 Oct.

. 2024 Oct:145:107662.

doi: 10.1016/j.cct.2024.107662. Epub 2024 Aug 12.

Collaborators

Randomized Control Trial Methods Workgroup of the Center for the Study of Tobacco Products: Member List:
Thomas Eissenberg⁹, Caroline O Cobb⁹, Phoebe Brosnan⁹, Nadia Chowdhury⁹, Jacob T Graham⁹, Alexa A Lopez⁹, Miao-Shan Yen⁹, Le Kang⁹, Shumei Sun⁹, Thokozeni Lipato⁹, Jonathan Foulds¹⁰, Erin Hammett¹⁰, Sharilee Hrabovsky¹⁰, Breianna L Hummer¹⁰, Courtney Lester¹⁰, John P Richie Jr¹⁰, Susan Veldheer¹⁰, Jessica M Yingst¹⁰, Christopher Sciamanna¹⁰, Sophia I Allen¹⁰, Christopher Bullen¹¹

Affiliations

¹ Department of Psychology, Virginia Commonwealth University, 612 N Lombardy St, Richmond, VA 23284, USA; Center for the Study of Tobacco Products, Virginia Commonwealth University, 100 West Franklin Street, Suite 200, Richmond, VA 23220, USA. Electronic address: cobbco@vcu.edu.
² Department of Biostatistics, Virginia Commonwealth University, One Capital Square 830 East Main Street, Richmond, VA 23219, USA.
³ Department of Psychology, Virginia Commonwealth University, 612 N Lombardy St, Richmond, VA 23284, USA; Center for the Study of Tobacco Products, Virginia Commonwealth University, 100 West Franklin Street, Suite 200, Richmond, VA 23220, USA.
⁴ Center for Research on Tobacco and Health, Penn State University College of Medicine, 30 Long Lane, Hershey, PA 17036, USA; Penn State University College of Medicine, Department of Public Health Sciences, 700 HMC Crescent Road, Hershey, PA 17033, USA.
⁵ Center for the Study of Tobacco Products, Virginia Commonwealth University, 100 West Franklin Street, Suite 200, Richmond, VA 23220, USA; Department of Biostatistics, Virginia Commonwealth University, One Capital Square 830 East Main Street, Richmond, VA 23219, USA.
⁶ Boston University, Department of Psychological and Brain Sciences, 64 Cummington Mall #149, Boston, MA 02215, USA.
⁷ NYU Langone Health, 550 First Avenue, New York, NY 10016, USA.
⁸ Department of Health, Behavior and Society, Institute for Global Tobacco Control, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
⁹ Virginia Commonwealth University, United States.
¹⁰ Penn State University, United States.
¹¹ The University of Auckland, New Zealand.

PMID: 39142511
PMCID: PMC11492368
DOI: 10.1016/j.cct.2024.107662

Abstract

Background: Mitigating attrition is a key component to reduce selection bias in longitudinal randomized controlled trials (RCTs). Few studies of electronic nicotine delivery systems (ENDS) allow for the examination of long-term retention. This analysis explores the relationship between attrition, baseline measures, and condition assigned for a RCT involving ENDS differing in nicotine delivery over a 24-week intervention period.

Methods: Participants (N = 520) who smoked ≥10 cigarettes per day [CPD] for ≥1 year and reported interest in reducing but not quitting were randomized to 1 of 4 conditions: an ENDS containing 0, 8, or 36 mg/ml liquid nicotine (administered double-blind) or a cigarette-shaped plastic tube. Cox proportional hazards regression models were fit to examine attrition over time and predictors of attrition including baseline characteristics and condition. A stepwise approach was used to determine the final model; alpha was set at 0.05.

Results: Attrition did not differ significantly by condition (223/520), and most (69%) were lost-to-follow-up. Only age, education level, and household income were significantly predictive of attrition. For every additional year of age, attrition risk fell by 3%. Holding a bachelor's degree or higher was associated with reduced attrition risk. Those with the lowest income (<$10 K) were more likely to be withdrawn compared to those earning $10 K-39 K, and those with the highest income ($100 K+) were more likely to be withdrawn compared with the latter bracket and those earning $70-99 K.

Conclusion: ENDS nicotine content did not drive differential attrition in this trial, and targeted retention efforts are needed for specific subgroups. Trial Registration #: NCT02342795.

Keywords: Attrition; Clinical trial; Electronic nicotine delivery system; Retention; Smoking.

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Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: JF has done paid consulting for pharmaceutical companies involved in producing smoking cessation medications, including Johnson & Johnson in the past 3 years, and has received a research grant and study drug (varenicline) from Pfizer prior to that, all of which are unrelated to the current study.

Figures

**Figure 1.**
Directed adjusted survival functions by study condition Log-rank test of equality over strata: χ²(3, N = 520) = 7.08, p = .070

See this image and copyright information in PMC

References

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Predictors of attrition in a randomized controlled trial of an electronic nicotine delivery system among people interested in cigarette smoking reduction

Collaborators

Affiliations

Predictors of attrition in a randomized controlled trial of an electronic nicotine delivery system among people interested in cigarette smoking reduction

Authors

Collaborators

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Substances

Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

Medical