Clinical trial

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

Name
American University Of Beirut
Description
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.
Trial arms
Trial start
2022-07-13
Estimated PCD
2024-09-13
Trial end
2025-01-31
Status
Recruiting
Treatment
e-liquid 1
30/70 PG/VG ratio with nicotine concentration 4mg/ml protonated
Arms:
Combination One - 16μg/s protonated nicotine flux
e-liquid 2
30/70 PG/VG ratio with nicotine concentration 10mg/ml protonated
Arms:
Combination Two - 32μg/s protonated nicotine flux
e-liquid 3
30/70 PG/VG ratio with nicotine concentration 4mg/ml free base
Arms:
Combination Three - 16μg/s free base nicotine flux
e-liquid 4
30/70 PG/VG ratio with nicotine concentration 10mg/ml freebase
Arms:
Combination Four - 32μg/s free base nicotine flux
e-liquid 5
30/70 PG/VG ratio with nicotine concentration 0mg/ml (placebo)
Arms:
Placebo - Combination Five - 0μg/s nicotine flux
Size
130
Primary endpoint
Subjective Measures of Nicotine Abstinence Symptoms - PROMIS-10 Global Health measures
Visit 1 - Before starting the first session
Subjective Measures of Nicotine Abstinence Symptoms - The corresponding 4-item E-Cigarette Dependence
Visit 1 - Before starting the first session
Subjective Measures of Nicotine Abstinence Symptoms - The corresponding 4-item Combustible cigarette Dependence
Visit 1 - Before starting the first session
Nicotine Dependence questionnaires - The Fagerstrom Test of Nicotine Dependence
Visit 1 - Before starting the first session
Subjective Measures of Nicotine Abstinence Symptoms - Product liking magnitude scale
Up to 180 minutes
Subjective Measures of Nicotine Abstinence Symptoms - Product liking hedonic scale
Up to 180 minutes
Subjective Measures of Nicotine Abstinence Symptoms - Drug Effect
Up to 180 minutes
Subjective Measures of Nicotine Abstinence Symptoms - Smoking urges
Up to 180 minutes
Subjective Measures of Nicotine Abstinence Symptoms - Hughes and Hatsukami
Up to 180 minutes
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Each participant will attend the lab for five different visits that differ by nicotine flux and/or form in random order.', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Each participant will attend the lab for five different visits that differ by nicotine flux and/or form in random order. All sessions will be double-blind (Participant / Investigator). The analytical chemist will be providing the investigator with e-liquid in a random order in each session for each participant.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 130, 'type': 'ESTIMATED'}}
Updated at
2023-12-08

1 organization

4 products

3 indications

Product
e-liquid
Indication
Nicotine Vaping
Product
E-Liquid
Product
E-liquid 3
Product
E-Liquid 4