A transdisciplinary model to inform randomized clinical trial methods for electronic cigarette evaluation

Abstract

BackgroundThis study is a systematic evaluation of a novel tobacco product, electronic cigarettes (ECIGs) using a two-site, four-arm, 6-month, parallel-group randomized controlled trial (RCT) with a follow-up to 9 months. Virginia Commonwealth University is the primary site and Penn State University is the secondary site. This RCT design is important because it is informed by analytical work, clinical laboratory results, and qualitative/quantitative findings regarding the specific ECIG products used.MethodsParticipants (N = 520) will be randomized across sites and must be healthy smokers of >9 cigarettes for at least one year, who have not had a quit attempt in the prior month, are not planning to quit in the next 6 months, and are interested in reducing cigarette intake. Participants will be randomized into one of four 24-week conditions: a cigarette substitute that does not produce an inhalable aerosol; or one of three ECIG conditions that differ by nicotine concentration 0, 8, or 36 mg/ml. Blocked randomization will be accomplished with a 1:1:1:1 ratio of condition assignments at each site. Specific aims are to: characterize ECIG influence on toxicants, biomarkers, health indicators, and disease risk; determine tobacco abstinence symptom and adverse event profile associated with real-world ECIG use; and examine the influence of ECIG use on conventional tobacco product use. Liquid nicotine concentration-related differences on these study outcomes are predicted. Participants and research staff in contact with participants will be blinded to the nicotine concentration in the ECIG conditions.DiscussionResults from this study will inform knowledge concerning ECIG use as well as demonstrate a model that may be applied to other novel tobacco products. The model of using prior empirical testing of ECIG devices should be considered in other RCT evaluations.Trial registrationTRN: NCT02342795, registered December 16, 2014.

E-cigarettes for the management of nicotine addiction

“…A number of RCTs are currently underway investigating the efficacy of second-generation products 57,58. Data from these studies will not be available for several years.…”

“…A number of RCTs are currently underway investigating the efficacy of second-generation products. 57 , 58 Data from these studies will not be available for several years. The onus will be on researchers to consider how they interpret their findings in the context of the EC landscape of the future.…”

Measurement of Electronic Cigarette Frequency of Use Among Smokers Participating in a Randomized Controlled Trial

“…Data were collected from a large US two-site randomized controlled trial evaluating the effects of e-cigs on toxicant exposure in smokers attempting to reduce their cigarette consumption (Clinical Trials identifier: NCT02342795). Details of the study can be found in Lopez et al 19 Only participants randomized to an e-cig condition were included in this analysis.…”

Effect of Electronic Nicotine Delivery Systems on Cigarette Abstinence in Smokers with no Plans to Quit: Exploratory Analysis of a Randomized Placebo-Controlled Trial

“…pregnancy, unstable serious medical or psychiatric conditions, or weekly or greater use of illegal drugs). Full inclusion/exclusion criteria have been published 11,12 and are available in the Supplement 1.…”

“…This report is based on exploratory analyses of a randomized placebo-controlled trial that was primarily designed to examine the effects of ENDS use on toxicant exposure in smokers. The methods and results for the primary toxicant outcome (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol, NNAL) have been reported elsewhere 11,12 .…”