A Naturalistic, Randomized Pilot Trial of E-Cigarettes: Uptake, Exposure, and Behavioral Effects

Abstract

Background Most studies of electronic nicotine delivery systems (ENDS) compare self-selected users vs. non-users. 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 (16mg vs. 24mg), midway through the study allowed a compelling opportunity to examine two ENDS products compared to control group. Primary outcomes, assessed via daily diaries during sampling period and in-person lab 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 24mg and 30% of 16mg using their assigned product for the entire sampling period. Within 24mg ENDs group, 57% made an independent purchase of ENDS, vs. 28% of 16mg, and 14% of control participants (p=.01). Smokers in both ENDS groups significantly reduced their smoking, whereas control participants did not (p=.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 towards 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.

Nicotine patches used in combination with e-cigarettes (with and without nicotine) for smoking cessation: a pragmatic, randomised trial

“…This change did not affect adherence (because product use at quit date was very high), but might limit the generalisable of the findings to policy environments where precessation use of NRT is not supported. Finally, serious adverse events were self-reported and similar to those reported in previous e-cigarette [3][4][5][6][7]9 and NRT trials. 16 However, the sample size was not sufficient to assess uncommon serious adverse events, nor was followup long enough to identify serious adverse events with a long lead-time.…”

“…1 E-cigarettes, mostly with nicotine, are used by smokers in many countries as an aid to quit smoking. 2 To date, seven clinical trials [3][4][5][6][7][8][9] (total N=8222; range n=68 to 6006) have investigated the efficacy and effectiveness of e-cigarettes for smoking cessation and overall suggest a net benefit. However, only four trials (N=7849; n=300 to 6006) had 6-month abstinence as a primary outcome 3,4,8,9 and only two trials (total N=6892) 8,9 tested a second-generation e-cigarette (capable of delivering nicotine more effectively than first-generation devices).…”

Prices, use restrictions and electronic cigarette use—evidence from wave 1 (2016) US data of the ITC Four Country Smoking and Vaping Survey

“…Fourthly, using the cross‐sectional data, we cannot make any causal inferences on the relationships between prices, use restrictions and behaviors of concurrent use and complete switch. Further, using cross‐sectional data, we cannot explain whether and to what extent concurrent use will ultimately lead to complete switch . Finally, a smaller sample size of the survey data may provide insufficient power to detect price effects on NVP use, concurrent use and complete switch.…”

Cigarrillo electrónico y otros sistemas electrónicos de liberación de nicotinarevisión de evidencias sobre un tema controversial

“…Otro estudio más pequeño, realizado en 2017 por Carpenter y colaboradores, en cambio, no logró demostrar que los CE fueran superiores a un grupo control en el logro de abstinencia, ni en el número de intentos de cesar. Nuevamente, sí se evidenció una reducción del número de cigarrillos al día en el grupo que usó CE (34) .…”