Clinical trial NCT06602492: Compensatory Behavior of E-cig Users in Response to Reduced Nicotine E-liquids
Official title: Compensatory Behavior of E-cig Users in Response to Reduced Nicotine E-liquids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Nicotine Addiction
Electronic Cigarette Use
Keywords: reduced nicotine eliquid
reduced exposure
cessation
Lead sponsor: Rochester Institute of Technology
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 72
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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:

* Does switching to lower nicotine eliquids change the vaping behavior of addicted ecig users?
* Does switching to lower nicotine eliquids reduce the amount of nicotine consumed? Researchers will compare ecig users who switch from a higher to lower nicotine eliquid to a control group that does not switch.

Participants will:

* Complete history of tobacco use and nicotine addiction questionnaires
* Switch from higher to lower nicotine product or control for 15 days
* Complete daily questionnaires to report craving, mood and nicotine withdraw

For one full day under each nicotine condition, participants will:

* record puffing behavior using a topography monitor
* wear a sensorized shirt that measures the depth and duration of inhalation, and
* collect a saliva sample at the end of each day

Detailed description: 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?

Eligibility criteria: Inclusion Criteria:

* 21 years or older
* Regular 30-day e-cig users

Exclusion Criteria:

* Intention to quit using e-cigs within the next 30 days
* Use of other tobacco products in addition to e-cigs on more than 9 of the previous 30 days
* History of acute or chronic asthma
* Previous diagnosis of cancer
* Other chronic medical conditions
* Use of chronic prescription medications
* Pneumonia in prior six weeks
* Upper respiratory tract infection or other febrile illness in previous 2 weeks
* Smokers on antioxidants, or anti-inflammatory therapy
* Pregnant women or women who intend to become pregnant or breast-feeding
* Had Covid-19 in the past 2 months or still feeling effects from a Covid-19 illness

Primary outcomes:
measure: 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.
timeFrame: From enrollment to the end of 17 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Rochester Institute of Technology
state: New York
Study officials:
affiliation: Rochester Institute of Technology
name: Risa J Robinson, PhD in Mechanical Engineering
role: PRINCIPAL_INVESTIGATOR
affiliation: Rochester Institute of Technology
name: Edward C Hensel, PhD in Mechanical Engineering
role: STUDY_DIRECTOR
affiliation: Rochester Institute of Technology
name: Stephanie Godleski, PhD in Clinical Psychology
role: STUDY_DIRECTOR
affiliation: Rochester Institute of Technology
name: Nathan Eddingsaas, PhD in Chemistry
role: STUDY_DIRECTOR
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