Establishing the Effect of Flavor on the Addictive Potential of Electronic Cigarettes (NCT03905928) | Clinical Trial Compass
CompletedNot Applicable
Establishing the Effect of Flavor on the Addictive Potential of Electronic Cigarettes
United States19 participantsStarted 2019-11-04
Plain-language summary
The current study aims to establish proof-of-concept that neural cue-reactivity can serve as an early, objective marker of electronic cigarette (ECIG) addictive potential. Further, this study will examine the effect of flavor and nicotine concentration on the addictive potential of ECIGs to aid research informing U.S. Food and Drug Administration (FDA) flavor regulations and smoking cessation.
Who can participate
Age range21 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Aged 21-60
✓. Smoke filtered cigarettes/machine-rolled cigarettes (≥5 cigarettes per day) or daily e-cigarette use for past year.
✓. No serious quit attempt in prior month. This includes use of any FDA approved smoking cessation medication (varenicline, bupropion \[used specifically as a quitting aid\], patch, gum, lozenge, inhaler, and nasal spray) in the past 1 month as an indication of treatment seeking.
✓. Willing to supplement cigarette smoking with ECIG use for 4 weeks or replace e-cigarette with study product for 4 weeks
✓. Willing to attend regular visits over a 4-week period (not planning to move, not planning extended vacation, no planned surgeries)
✓. Willing to undergo two fMRI scans
✓. Able to read and write in English
✓. Able to understand and consent to study procedures
Exclusion criteria
✕. Impaired smell function as measured via a standardized screening assessment
✕. Unstable or significant medical condition in the past 12 months (recent heart attack or some other heart conditions, stroke, severe angina including high blood pressure)
✕. Severe immune system disorders (uncontrolled Human Immunodeficiency virus infection; unstable multiple sclerosis symptoms), respiratory diseases (exacerbations of asthma or chronic obstructive pulmonary disorder, require oxygen, require oral prednisone), kidney (dialysis) or liver diseases (cirrhosis), or any medical disorder/medication that may affect participant safety or biomarker data
What they're measuring
1
Baseline Neural Flavor Cue-reactivity at Baseline
Timeframe: Baseline
2
Changes in Neural Flavor Cue-reactivity Across Nicotine Groups
Timeframe: Baseline to 4-weeks
3
Changes in Neural Flavor Cue-reactivity Across Flavor Groups