Clinical trial NCT05430334: Assess the Influence of Nicotine Flux and Nicotine Form on Subjective Effects Related to Dependency
Official title: Nicotine Flux, a Potentially Powerful Tool for Regulating Nicotine Delivery From Electronic Cigarettes: Significance of Nicotine Flux to the Rate of Nicotine Delivery and Subjective Effect
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nicotine Vaping
Nicotine Dependence
Nicotine Addiction
Keywords: Nicotine
Nicotine Flux
Vaping
ENDS
Aerosol
Combustible
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Drug Abuse (NIDA)
First posted: 2022-06-24
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each participant will attend the lab for five different visits that differ by nicotine flux and/or form in random order.
Primary purpose: OTHER

Brief summary: Electronic nicotine delivery systems (ENDS) heat and vaporize a nicotine-containing liquid to produce an aerosol that can deliver nicotine to the blood and the brain. ENDS use has increased rapidly in the last decade, especially among youth: over 20% of US high school students are current ENDS users, and there is evidence of nicotine dependence in this population. Federal legislation has been proposed that would restrict ENDS liquid nicotine concentration to make ENDS "significantly less addictive and appealing to youth." However, these and other efforts to curb addiction by limiting nicotine liquid concentration are unlikely to succeed because nicotine emissions from ENDS depend on multiple variables. To achieve the intended public health aims, regulations targeting addiction must focus on nicotine delivery, not nicotine concentration. While nicotine delivery cannot be regulated directly, the rate at which an ENDS emits nicotine, the "nicotine flux", can be regulated and, importantly, predicted based on a few device design and operating variables. However, to date there is no empirical evidence demonstrating the relationship between flux and delivery, nor between flux and the subjective effects that support nicotine dependence. Closing this gap is essential for providing an effective framework for regulating ENDS. At the American University of Beirut, the investigators will assess the relationship between nicotine flux, form, and subjective effects. Participants will use ENDS devices with varying nicotine fluxes and forms. Dependency measures, such as urge to smoke, craving, and abstinence, will be assessed. The outcome will indicate the degree to which nicotine flux/form influence subjective effects related to dependency, puffing intensity, and exposure to toxicants. In summary, this project will provide the empirical evidence needed for public health agencies to use nicotine flux as an encompassing and convenient construct to regulate nicotine delivery from ENDS.

Detailed description: Assess the influence of nicotine flux and nicotine form on subjective effects. At AUB, the investigators will assess subjective effects (e.g. product liking, nicotine craving) and puffing topography for 130 participants who will undergo 5 ENDS use sessions consisting of 2 bouts (10 puffs + 60min ad libitum) with 2 fluxes (16 and 32μg/s) x 2 forms (protonated, freebase) and a 0 nicotine condition. In addition, the investigators will use a state-of-the-art device to sample in situ a fraction of the aerosol generated during each puff to verify actual nicotine flux and form, and measure exposure to pulmonary toxicants (carbonyls). The investigators hypothesize that increasing nicotine flux and protonated nicotine will result in greater reductions of nicotine craving, and lower puffing intensity and carbonyl exposure.

Eligibility criteria: Inclusion Criteria:

* Must be healthy and above 18 years of age
* Must be willing to provide informed consent, attend the lab, and abstain from tobacco/nicotine as required (participants will be instructed to abstain from nicotine/tobacco and/or ENDS use for ≥12h)
* A dual ENDS and tobacco user who reports daily use of ENDS (≥ 3 mg/ml nicotine) or cigarettes (any frequency) AND someday use (≥ 3 days/week) of ENDS (≥ 3 mg/ml nicotine) or cigarettes (any frequency) for the past 3 months or longer

Exclusion Criteria:

* History of chronic disease or an uncontrolled psychiatric condition
* History of or active cardiovascular disease, low/high blood pressure, seizures, regular use of a prescription medication (except vitamins/birth control)
* Past month use of cocaine, opioids, benzodiazepines, or methamphetamines
* Individuals who report using marijuana \>15/30 days
* Women will be excluded if they are breast-feeding or pregnant
* Participants intending to quit tobacco/nicotine use in the next 30 days and referred to cessation treatment

Primary outcomes:
measure: Subjective Measures of Nicotine Abstinence Symptoms - PROMIS-10 Global Health measures
timeFrame: Visit 1 - Before starting the first session
measure: Subjective Measures of Nicotine Abstinence Symptoms - The corresponding 4-item E-Cigarette Dependence
timeFrame: Visit 1 - Before starting the first session
measure: Subjective Measures of Nicotine Abstinence Symptoms - The corresponding 4-item Combustible cigarette Dependence
timeFrame: Visit 1 - Before starting the first session
measure: Nicotine Dependence questionnaires - The Fagerstrom Test of Nicotine Dependence
timeFrame: Visit 1 - Before starting the first session
measure: Subjective Measures of Nicotine Abstinence Symptoms - Product liking magnitude scale
timeFrame: Up to 180 minutes
measure: Subjective Measures of Nicotine Abstinence Symptoms - Product liking hedonic scale
timeFrame: Up to 180 minutes
measure: Subjective Measures of Nicotine Abstinence Symptoms - Drug Effect
timeFrame: Up to 180 minutes
measure: Subjective Measures of Nicotine Abstinence Symptoms - Smoking urges
timeFrame: Up to 180 minutes
measure: Subjective Measures of Nicotine Abstinence Symptoms - Hughes and Hatsukami
timeFrame: Up to 180 minutes
Secondary outcomes:
measure: Puff Duration
timeFrame: Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
measure: Flow rate
timeFrame: Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
measure: Puff Interval
timeFrame: Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
measure: Number of Puffs
timeFrame: Will be measured during the approximately 60-minute, ad lib use bout
measure: Liquid consumed
timeFrame: Will be measured after the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
measure: Carbonyl compound yield
timeFrame: Will be measured after the 60-minute, ad lib use bout
measure: Nicotine flux
timeFrame: Will be measured after the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut
Study officials:
affiliation: American University of Beirut Medical Center
name: Soha Talih, PhD
role: PRINCIPAL_INVESTIGATOR
References: