An Early Phase 1 interventional study of Lower nicotine e-liquid and Higher nicotine eliquid in Healthy, Nicotine Addiction and Electronic Cigarette Use, sponsored by Rochester Institute of Technology. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2024-09-27.
Sponsored by Rochester Institute of Technology · Early Phase 1, Interventional, and Treatment
The goal of this clinical trial is to learn if low nicotine eliquids work to reduce exposure to nicotine, in addicted ecig users, without increasing consumption of other harmful constituents.
The main questions it aims to answer are:
Participants will:
For one full day under each nicotine condition, participants will:
This project will investigate whether and how e-cig users compensate puff topography, lung inhalation, and cumulative consumption in response to reduced nicotine eliquid. The project is conducted in the natural environment to objectively measure if users adapt their behavior to maintain their desired level of nicotine.
The project employs a novel behavior-based exposure model that leverages the unique abilities of the investigative team to objectively capture real world behavior. The study employs a novel wPUM™ monitor to record puffing topography and a sensorized shirt to record respiratory parameters for every vaping session.
This study is conducted in the natural environment over 17 days. We will recruit N=80 current established adult ecig users, currently using eliquids with nicotine strengths greater than or equal to 5%, with no intention to quit e-cig use, and no use of combustible or other tobacco products. Participants will be randomized by age, gender, usual brand nicotine strength, and nicotine dependence score into a control arm (non-switching) and a test arm (switching). All participants will be baselined with 5% Juul ecigs and Juul pods containing Virginia Tobacco at 5% nicotine strength. The test arm will be switched to a 3% Juul pods containing Virginia Tobacco at 3% nicotine strength eliquid, while the control arm will continue to use 5% nicotine strength.
Participants will use the RIT wPUM monitor with a Juul ecig and a wearable sensorized garment to record their e-cigarette use topography and inhalation behavior ad-lib in their natural environment at the baseline and intervention conditions for one day each. Biosamples for nicotine exposure in saliva, NNAL in urine and CO will be collected, along with questionnaires to assess product use, compliance, and psychosocial outcomes such as craving, withdrawal and positive/negative emotional state.
Aim 1. Quantify changes in Total Particulate Matter (TPM) exposure among e-cig users adapting to low nicotine eliquids through compensatory changes in puffing, inhalation, and consumption behavior.
TPM exposure will be quantified in the natural environment by recording the topography (puff flow rate, duration, volume) of every puff taken along with respiratory behavior (inhalation/exhalation volume and time and breath hold). This novel outcome measure of exposure is used as a proxy to indicate the impact of behavior on increasing harm potential. We will test hypothesis (H1) that upon changing to a lower nicotine eliquid, users will adapt their behavior (i.e. increase breath hold, adjust puff flow rate, etc.), and in doing so will increase their TPM exposure.
Aim 2. Quantify changes in salivary among e-cig users adapting to low nicotine eliquids.
Salivary cotinine will be measured as a proxy to indicate efficacy of compensatory behavior. A Generalized Linear Mixed-Effects Model (GLME) analysis will be used to investigate how the ability of users to compensate for low nicotine e-liquids is affected by the presence of random effects including sex, age, nicotine dependence score, usual brand nicotine strength, and subjective effects including craving, withdrawal symptoms, and positive/negative emotional state. We will test the hypothesis (H2) that users are able to maintain desired nicotine levels while using a lower nicotine eliquid.
Relationship to Tobacco Regulation: Knowledge gained will support development of effective tobacco product regulations by informing three research questions of regulatory interest: (a) Will limiting the eliquid nicotine concentration reduce harm at the population level? (b) Is there evidence of compensatory behavior exhibited by e-cig users in response to reduced nicotine concentration, and (c) Can we conduct meaningful behavior-based e-cig use risk assessment at the individual level?
968 studies on the registry are indexed under Tobacco Use Disorder; 128 are open to participants now.
This study's enrollment of 72 is below the median of 90 across 851 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →Rochester Institute of Technology is the lead sponsor of 6 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Baselined with a high nicotine eliquid and switched to a low nicotine eliquid.
Drug: Lower nicotine e-liquid
Baselined with a high nicotine eliquid and continue with the same high nicotine eliquid.
Drug: Higher nicotine eliquid
A 3% nicotine concentration eliquid.
A 5% nicotine concentration eliquid.
Change in the Total Particular Mass (TPM) exposure when switching from the baseline to the intervention condition (high to low nicotine), based on the novel behavior-based yield model.
A behavior-based yield model, which combines product emissions with real-world user topography, is used to estimate the Change in Cumulative TPM exposure between low and high nicotine products. Total Particulate Mass (TPM) exposure of nicotine or other Harmful and Potentially Harmful Constituents (HPHCs) increases as a joint function of (1) the TPM delivered from the e-cig to the mouth, (2) the volume of diluting 'clean air' inhaled with the e-cig puff, and (3) the duration of time the emissions are in the lung. TPM exposure is proportional to the product of the TPM, which is the particulate mass contained in each puff delivered to the mouth (quantified by recording the volume of every puff and measuring the associated mass concentration in the emissions), v-inhale, which is the volume of air and entrained ecig aerosol inhaled into the lung with each puff (quantified with a senorized shirt), and t-cycle, which is the total time for the user to inhale each puff, hold their breath an
Time frame: From enrollment to the end of 17 days.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Rochester Institute of Technology