WithdrawnNot Applicable

Understanding Factors That Influence Electronic Cigarette Nicotine Delivery Through PET Imaging of Beta-2 Nicotinic Acetylcholine Receptors

Stopped: Recruitment halted by pandemic

United States0Started 2022-12-30

Plain-language summary

The goal of this proposal is to test the overall hypothesis that e-cigarettes (ECs) provide efficient nicotine delivery to the brain and arterial blood in non-EC-naïve smokers and e-cigarette users and that EC liquid characteristics modulate this effect. This study will test the hypothesis through complementary methods that include \[ \[18F\]NCFHEB (aka \[18F\]Flubatine) PET neuroimaging, arterial blood nicotine measurements, and subjective drug effects assessments.

Who can participate

Age range

21 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Men and women, aged 21-55 years * Able to read and write English * Able to give voluntary, written informed consent * Current cigarette smoking or e-cigarette use * Non-treatment seeking * Exhaled CO \> 10 ppm or urine cotinine \> 50 ng/ml * Agreement to only use e-cigarette products provided in the study * Not naïve to vaping (3 or more months and 12 or more times). Exclusion Criteria: * Current medical condition such as neurological, pulmonary, cardiovascular, endocrine, renal, liver, or thyroid pathology * History of or current neurological or psychiatric disorder including drug or alcohol dependence (as per SCID for DSM-5) except Nicotine Dependence * Regular or current use of any prescription, herbal or illegal psychotropic medications in the past 1 year, with no current illegal drug use confirmed by urine toxicology (including cannabis) * Drink more than 14 drinks per week for women or 21 drinks per week for men; * Women who are pregnant or nursing * Individuals who are currently taking medication that may affect cholinergic system or nicotine replacement therapy prescribed for smoking cessation; * Contraindications to MRI such as claustrophobia or metal in their body, or to PET such as history of cancer Patient unlikely to be able to complete the study as determined by the PI or research assistants * Blood donation within eight weeks of the start of the study * History of a bleeding disorder or are currently taking anticoagulants (such as Couma…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Brain beta-2 nicotinic acetylcholine receptor occupancy

Timeframe: 210 minutes

Trial details

NCT IDNCT04258852

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-01

View on ClinicalTrials.gov More Electronic Cigarette Use trials