Understanding Factors That Influence Electronic Cigarette Nicotine Delivery Through PET Imaging of Beta-2 Nicotinic Acetylcholine Receptors
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- STATUS
- Recruiting
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- days left to enroll
- 21
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- participants needed
- 20
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- sponsor
- Yale University
Summary
The goal of this proposal is to test the overall hypothesis that e-cigarettes (ECs) provide
efficient nicotine
Description
C.2 Subject Inclusion and Assessments Overall study design: Non-EC-nave smokers or
e-cigarette users (n=20) will abstain from tobacco smoking/nicotine products for 5 days prior
to each
C.2.b Subjects: Twenty non-EC-nave tobacco dependent smokers or e-cigarette users will be
recruited for the study. All research subjects will be recruited under guidelines of the Yale
University Institutional Review Board (Human Investigation Committee). Smokers will be
recruited from the community via IRB-approved advertising. After completing informed consent,
subjects will have a psychiatric, physical and
C.2.c Clinical Assessments: A standardized battery will be administered to all subjects at
intake including Health Questionnaire, the
Baseline and after each
- Health Questionnaire
- PROMIS
Dyspnea Severity Item Pool - PROMIS
Dyspnea Characteristics - PROMIS
Fatigue Short Form Functional Assessment ofChronic Illness Therapy (FACIT) Cough item- The health questionnaire titled 'assessment of health problems' (and provided as an attachment via a comment in IRES) will be added to the protocol and will be completed at intake and before each exposure. Note that potential subjects with chronic symptoms that would interfere with monitoring of vaping complications, will not be enrolled.
Positive findings of a change in symptom or single severe symptom would trigger clinical referral to a treating physician or the emergency room.
C.2.d
C.2.e - MRI/cognitive testing Subjects will be asked to go to the MRRC at The Anlyan Center
for Medical Research & Education (TAC, 300 Cedar Street) to have an MRI (
The
Two sessions of testing of their memory, attention, and concentration may take place. This
will take approximately 1hr total. They will be given a break between these sessions. This
may take place on the same day as the
During this visit, they may play a computer game called the Face Game. The goal of the Face Game is to win as much money as possible. They may earn money by quickly and correctly pressing one of two keys on the keyboard, each time they see a face on the screen. They will press one key if they think that the mouth on the face is long, and the other if they think it is short.
Impulsivity Subjects may be asked to play a game in which they will use a computer mouse to
click a balloon pump that inflates a balloon on the screen. The objective of the task is to
get the largest amount of the money possible while avoiding balloon explosions. This
assessment tests their impulsivity. They may be asked to play this game on the day of their
C.3.
[18F]NCFHEB will be synthesized and administered on
Use of EC: Subjects will receive 2 different scans and will puff one of two EC products (in
random order, counterbalanced): "JUUL" 5% (50 mg/ml), a common commercially available
unmodified nicotine salt EC, and (2) JUUL 3% (30 mg/ml), a lower nicotine strength product.
Only tobacco flavor will be used. A training session to familiarize smokers with the EC
product used in the study will be conducted at an appointment prior to the
Use of Regular Cigarette: A third
Blood Samples: On
Image Analysis and Outcome Measure: List-mode PET data will be reconstructed with OSEM with
built-in corrections for attenuation, normalization, scatter, randoms, deadtime and subject
motion.53,54 Following image reconstruction, a summed image will be registered to the
subject's MRI. Regions of interest (ROIs) will be anatomically defined using a template
[Anatomical Automatic Labeling (AAL)] coregistered to the subject's MRI image. ROIs used for
calculation of receptor occupancy will be: cerebellum, frontal, parietal, temporal, and
occipital cortices, caudate, putamen, hippocampus, and amygdala. These regions are chosen
because they were previously examined in 2*-nAChR studies, have significant density in the
human brain, and are relevant to the craving and withdrawal properties of nicotine. The
thalamus will not be included because equilibrium is not reached in this region with the
bolus-infusion paradigm. The volume of distribution VT will be estimated using the
equilibrium ratio between total radioactivity concentration in tissue and parent
concentration in arterial plasma. Baseline VT will be estimated from 90-120 min after
Details
Condition | Electronic Cigarette Use |
---|---|
Age | 21years - 55years |
Treatment | Low strength nicotine e-liquid, High strength nicotine e-liquid |
Clinical Study Identifier | NCT04258852 |
Sponsor | Yale University |
Last Modified on | 19 February 2024 |
How to participate?
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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