Social Construction, Language, and the Authority of Knowledge and a Polemical History of Freshman Composition in Our Time - Comment

Englis

Recommended items to address in a clinical trial protocol and related documents.

Recommended items to address in a clinical trial protocol and related documents.</p

American University of Beirut protocol.

IntroductionElectronic cigarette (EC) use has increased rapidly in the last decade, especially among youth. Regulating nicotine delivery from ECs could help curb youth uptake and leverage EC use in harm reduction yet is complicated by varying device and liquid variables that affect nicotine delivery. Nicotine flux, the nicotine emission rate, is a parameter that incorporates these variables and focuses on the performance rather than the design of an EC. Nicotine flux therefore could be a powerful regulatory tool if it is shown empirically to predict nicotine delivery and subjective effects related to dependence.Methods and analysisThis project consists of two complementary clinical trials. In Trial I, we will examine the relationship between nicotine flux and the rate and dose of nicotine delivery from ECs, hence, impacting abuse liability. It will also examine the extent to which this relationship is mediated by nicotine form (i.e., freebase versus protonated). At Yale School of Medicine (YSM), study participants will puff EC devices under conditions that differ by flux and form, while arterial blood is sampled in high time resolution. In Trial II, we will assess the relationship between nicotine flux, form, and subjective effects. At the American University of Beirut (AUB), participants will use EC devices with varying nicotine fluxes and forms, while dependency measures, such as the urge to use ECs, nicotine craving, and withdrawal symptoms, will be assessed. We will also monitor puffing intensity and real-time exposure to toxicants.Ethics and disseminationThe protocol of Trial I and Trial II was approved by YSM and AUB IRBs, respectively. We will disseminate study results through peer-reviewed publications and conference presentations.Trial registrationNCT05706701 for Trial I and NCT05430334 for Trial II.</div

Standard protocol items: Recommendations for interventional trials (SPIRIT) recommended content for the schedule of enrolment, interventions, and assessments for Trial I.

Standard protocol items: Recommendations for interventional trials (SPIRIT) recommended content for the schedule of enrolment, interventions, and assessments for Trial I.</p

Trial II study design with time points to collect survey data and RealTIME samples.

Trial II study design with time points to collect survey data and RealTIME samples.</p

Yale school of medicine IRB protocol.

IntroductionElectronic cigarette (EC) use has increased rapidly in the last decade, especially among youth. Regulating nicotine delivery from ECs could help curb youth uptake and leverage EC use in harm reduction yet is complicated by varying device and liquid variables that affect nicotine delivery. Nicotine flux, the nicotine emission rate, is a parameter that incorporates these variables and focuses on the performance rather than the design of an EC. Nicotine flux therefore could be a powerful regulatory tool if it is shown empirically to predict nicotine delivery and subjective effects related to dependence.Methods and analysisThis project consists of two complementary clinical trials. In Trial I, we will examine the relationship between nicotine flux and the rate and dose of nicotine delivery from ECs, hence, impacting abuse liability. It will also examine the extent to which this relationship is mediated by nicotine form (i.e., freebase versus protonated). At Yale School of Medicine (YSM), study participants will puff EC devices under conditions that differ by flux and form, while arterial blood is sampled in high time resolution. In Trial II, we will assess the relationship between nicotine flux, form, and subjective effects. At the American University of Beirut (AUB), participants will use EC devices with varying nicotine fluxes and forms, while dependency measures, such as the urge to use ECs, nicotine craving, and withdrawal symptoms, will be assessed. We will also monitor puffing intensity and real-time exposure to toxicants.Ethics and disseminationThe protocol of Trial I and Trial II was approved by YSM and AUB IRBs, respectively. We will disseminate study results through peer-reviewed publications and conference presentations.Trial registrationNCT05706701 for Trial I and NCT05430334 for Trial II.</div

Trial I study design and restricted randomization of conditions.

Trial I study design and restricted randomization of conditions.</p

Nicotine flux from different generations of e-cigarettes (ECs) and other nicotine-delivering products.

Generations of e-cigarettes were determined according to. (TIF)</p