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

• Status: Recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Acetylcholine; Nicotine

Criteria

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 Coumadin, Heparin, Pradaxa, Xarelto)

• Known hypersensitivity to propylene glycol

• Planning to quit smoking with a set goal or time for quit attempt

• Untreated, unresolved acute pulmonary conditions (recurring bronchitis and Reactive airway disorder, as examples).

• Chronic symptoms on Health Questionnaire that would interfere with monitoring of vaping complication

• Naïve to vaping (vaping for less than 3 months and less than 12 times)