A naturalistic, randomized pilot trial of e-cigarettes: uptake, exposure, and behavioral effects.
Open accessAbstract
Background: Most studies of electronic nicotine delivery systems (ENDS) compare self-selected users versus nonusers. The few randomized studies to date generally support a positive impact on reducing smoking behavior, but these studies are focused on guided ENDS use. This study presents a randomized, naturalistic trial of ENDS with prospective outcomes of uptake and behavioral changes in smoking. Methods: Adult smokers with minimal ENDS history were randomized in a 2:1 ratio to receive product for 3 weeks (n = 46), or not (n = 22). Changes in nicotine delivery (16 vs. 24 mg), midway through the study allowed a compelling opportunity to examine two ENDS products compared with the control group. Primary outcomes, assessed via daily diaries during sampling period and in-person laboratory visits over 4 months, included uptake and usage of ENDS, cessation-related outcomes, and exposure to smoke constituents. Results: All ENDS participants tried product at least once, with 48% of 24 mg and 30% of 16 mg using their assigned product for the entire sampling period. Within the 24 mg ENDs group, 57% made an independent purchase of ENDS, versus 28% of 16 mg, and 14% of control participants (P = 0.01). Smokers in both ENDS groups significantly reduced their smoking, whereas control participants did not (P = 0.03). Cessation behaviors (quit attempts, biologically verified abstinence) numerically but not statistically favored ENDS participants. Conclusions: Results suggest that cigarette smokers are willing to use ENDS with trends toward reduced cigarette smoking and positive changes in cessation-related behaviors. Impact: Randomized, naturalistic trials such as presented herein are needed to understand the population impact of e-cigarettes. Cancer Epidemiol Biomarkers Prev; 26(12); 1795–803. ©2017 AACR.
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Five trials (N=3,117) were included that evaluated the effectiveness of using e-cigarettes to help current conventional smokers stop or reduce smoking compared with placebo or nicotine replacement therapy.
“Five trials (N=3,117) were included that evaluated the effectiveness of using e-cigarettes to help current conventional smokers stop or reduce smoking compared with placebo or nicotine replacement therapy ([eTable 3](#SD1)).[76](#R76),[77](#R77),[86](#R86),[87](#R87),[89](#R89)”
From Interventions for Tobacco Cessation in Adults, Including Pregnant Persons (2021) · cites this paper as [77]
The paper’s Methods describe a randomized trial in 68 adult smokers that assessed e-cigarette use and cessation-related outcomes. But the Discussion says its comparator was a non-sampling control, not a placebo e-cigarette or nicotine replacement therapy. The paper also does not establish the citing document’s aggregate of five trials (N=3,117). (LLM, conf=0.90)
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- Authors
- Carpenter, M. J., Heckman, B. W., Wahlquist, A. E., Wagener, T. L., Goniewicz, M. L., Gray, K. M., Froeliger, B., & Cummings, K. M.
- Affiliations
- Medical University of South Carolina (US)
- University of Oklahoma Health Sciences Center (US)
- Roswell Park Comprehensive Cancer Center (US)
- Corresponding author
- Carpenter, Matthew J.
- ORCID
- Venue
- Cancer Epidemiology, Biomarkers & Prevention
- Published
- 2017-11-30
- Volume
- 26
- Issue
- 12
- Pages
- 1795-1803
- ISSN
- 1055-9965 (ISSN-L)
- 1538-7755
- PMC
- PMC5713898
- OpenAlex
- W2767521941
- Semantic Scholar
- 2afb2a4cc3bf7be166676337d83a12b37bfe1dfb
- Cited by
- 93
- References
- 58
- Citations by year
- 2026: 3 · 2025: 7 · 2024: 20 · 2023: 5 · 2022: 8 · 2021: 16 · 2020: 14 · 2019: 12 · 2018: 6 · 2016: 1 · 2012: 1
- FWCI
- 6.48
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Cancer Epidemiology Biomarkers & Prevention (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- NIH (R21 DA037407, P01 CA200512, UL1 TR001450, and P30 CA138313)
- Topics
- Health Sciences › Medicine › Physiology › Smoking Behavior and Cessation
- Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Inhalation and Respiratory Drug Delivery
- Keywords
- electronic cigarettes, smoking cessation, quit attempts, abstinence
- MeSH terms
- Adult, Female, Humans, Male, Middle Aged, Nicotine, Pilot Projects, Prospective Studies, Smoking Cessation, Tobacco Use Cessation Devices, Electronic Nicotine Delivery Systems
About these checks
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