NCT05430334

Assess the Influence of Nicotine Flux and Nicotine Form on Subjective Effects Related to Dependency

Completed NA Last updated 17 July 2025

What this trial tests

NA trial testing e-liquid 1 in Nicotine Vaping in 130 participants. Completed in 11 July 2025.

Timeline

13 July 2022

Primary endpoint
11 July 2025

11 July 2025

Quick facts

Lead sponsor	American University of Beirut Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	other
Enrollment	130
Start date	13 July 2022
Primary completion	11 July 2025
Estimated completion	11 July 2025
Sites	1 location across Lebanon

Drugs / interventions tested

• e-liquid 1
• e-liquid 2
• e-liquid 3
• e-liquid 4
• e-liquid 5
• e-liquid 6
• e-liquid 7 and e-liquid 8
• e-liquid 9 and e-liquid 10

Conditions studied

• Nicotine Vaping — all drugs for Nicotine Vaping →
• Nicotine Dependence — all drugs for Nicotine Dependence →
• Nicotine Addiction — all drugs for Nicotine Addiction →

Sponsor

American University of Beirut Medical Center

Who can join

18 and older, any sex, with Nicotine Vaping or Nicotine Dependence. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Interventions to prevent or cease electronic cigarette use in children and adolescents.
   Barnes C, Turon H, McCrabb S, Hodder RK, et al · · 2023 · cited 14× · PMID 37965949 · DOI 10.1002/14651858.cd015511.pub2
2. Influence of nicotine form and nicotine flux on puffing behavior and mouth-level exposure to nicotine from electronic nicotine delivery systems.
   Talih S, Hanna E, Salman R, Salam S, et al · · 2024 · cited 5× · PMID 38103538 · DOI 10.1016/j.drugalcdep.2023.111052
3. Nicotine flux as a powerful tool for regulating nicotine delivery from e-cigarettes: Protocol of two complimentary randomized crossover clinical trials.
   El-Hellani A, Hanna E, Sharma M, Blohowiak R, et al · · 2023 · cited 1× · PMID 37733666 · DOI 10.1371/journal.pone.0291786