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

Area of Science:

• Tobacco regulatory science
• Clinical trial methodology
• Public health research

Background:

• Systematic evaluation of electronic cigarettes (ECIGs) via a two-site, four-arm, 6-month randomized controlled trial (RCT).
• RCT design informed by analytical, clinical laboratory, and qualitative/quantitative findings on specific ECIG products.
• Trial registration: NCT02342795.

Purpose of the Study:

• Characterize ECIG influence on toxicants, biomarkers, health indicators, and disease risk.
• Determine the profile of tobacco abstinence symptoms and adverse events associated with ECIG use.
• Examine ECIG use's influence on conventional tobacco product consumption.

Main Methods:

• 520 healthy smokers randomized into four 24-week conditions: non-aerosolizing cigarette substitute or ECIGs with 0, 8, or 36 mg/ml nicotine.
• Blocked randomization with a 1:1:1:1 ratio at each site.
• Participants and research staff blinded to nicotine concentration in ECIG conditions.

Main Results:

• Nicotine concentration differences in ECIGs are predicted to impact study outcomes.
• Study aims to characterize ECIG effects on health indicators and disease risk.
• Analysis will focus on toxicants, biomarkers, and abstinence symptoms.

Conclusions:

• Study results will enhance knowledge regarding ECIG use and novel tobacco product evaluation.
• The model of using prior empirical testing of ECIG devices should be considered for other RCT evaluations.
• Findings will inform regulatory science and public health strategies concerning novel tobacco products.