Examining how nicotine delivery affects dependence and cravings
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
NA · American University of Beirut Medical Center · NCT05430334
This study is testing how different ways of delivering nicotine in e-cigarettes affect cravings and dependence in users.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | American University of Beirut Medical Center (other) |
| Locations | 1 site (Beirut) |
| Trial ID | NCT05430334 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of different nicotine delivery rates and forms on subjective experiences related to nicotine dependence among users of electronic nicotine delivery systems (ENDS). A total of 130 participants will engage in five sessions where they will use ENDS with varying nicotine flux levels and forms, while their cravings and puffing behaviors are monitored. The study aims to determine how these variables influence nicotine craving and exposure to harmful substances. By analyzing the relationship between nicotine delivery and dependence, the research seeks to inform public health regulations regarding ENDS.
Who should consider this trial
Good fit: Ideal candidates are healthy adults over 18 who are dual users of ENDS and tobacco, with a history of regular nicotine use.
Not a fit: Patients with chronic diseases, uncontrolled psychiatric conditions, or those intending to quit nicotine use may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective regulations that reduce nicotine dependence among users, particularly youth.
How similar studies have performed: While there is ongoing research into nicotine delivery systems, this specific approach focusing on nicotine flux and form is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beirut
- American University of Beirut — Beirut, Lebanon (RECRUITING)
Study contacts
- Principal investigator: Soha Talih, PhD — American University of Beirut Medical Center
- Study coordinator: Soha Talih, PhD
- Email: st38@aub.edu.lb
- Phone: +961-1-350000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Nicotine Vaping, Nicotine Dependence, Nicotine Addiction, Nicotine, Nicotine Flux, Vaping, ENDS, Aerosol