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

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.

Conditions

• Nicotine Vaping
• Nicotine Dependence
• Nicotine Addiction

Interventions

COMBINATION_PRODUCT

e-liquid 1

30/70 PG/VG ratio with nicotine concentration 4mg/ml protonated

COMBINATION_PRODUCT

e-liquid 2

30/70 PG/VG ratio with nicotine concentration 10mg/ml protonated

COMBINATION_PRODUCT

e-liquid 3

30/70 PG/VG ratio with nicotine concentration 4mg/ml free base

COMBINATION_PRODUCT

e-liquid 4

30/70 PG/VG ratio with nicotine concentration 10mg/ml freebase

COMBINATION_PRODUCT

e-liquid 5

30/70 PG/VG ratio with nicotine concentration 0mg/ml (placebo)

COMBINATION_PRODUCT

e-liquid 6

30/70 PG/VG ratio with nicotine concentration 0mg/ml

COMBINATION_PRODUCT

e-liquid 7 and e-liquid 8

e-liquid 7: 30/70 PG/VG ratio with nicotine concentration 4mg/ml protonated e-liquid 8: 30/70 PG/VG ratio with nicotine concentration 8mg/ml protonated

COMBINATION_PRODUCT

e-liquid 9 and e-liquid 10

e-liquid 9: 30/70 PG/VG ratio with nicotine concentration 4mg/ml protonated e-liquid 10: 70/30 PG/VG ratio with nicotine concentration 4mg/ml protonated

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• American University of Beirut Medical Center

  lead OTHER

Principal Investigators

• Soha Talih, PhD · American University of Beirut Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-07-13

Primary Completion

2025-07-11

Completion

2025-07-11

Countries

• Lebanon

Study Locations