Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-31 @ 10:23 PM
Study NCT ID:
NCT03098004
Status:
COMPLETED
Last Update Posted:
2023-07-11
First Post:
2017-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of e-Cigarettes on Nicotine Withdrawal
Sponsor:
University of Southern California
Organization:
Study Overview
Official Title:
Effects of Electronic Cigarettes on Nicotine Withdrawal Among Smokers
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This behavioral pharmacology laboratory experiment will assess whether sweet (vs. non-sweet) flavored e-cigarette solutions reduce tobacco withdrawal symptoms and motivation to smoke among 40 smokers interested in trying e-cigarettes (for the first time) following 16-hours of nicotine abstinence. The study's experimental design will provide evidence of the causal effects of e-cigarette flavorings on a putatively critical factor for determining whether smokers continue e-cigarette use after initial trial-the ability of a product to suppress withdrawal and motivation to smoke during periods of tobacco deprivation.
Detailed Description:
Nicotine withdrawal symptoms (e.g., increased negative affect, decreased positive affect, cigarette craving) are a core component of cigarette dependence that emerge upon the absence of nicotine administration, maintaining cigarette smoking and inhibiting cessation efforts. The use of electronic cigarettes (e-cigarettes) has increased dramatically in recent years, with studies demonstrating that e-cigarettes can reduce nicotine withdrawal symptoms during acute cigarette abstinence. E-cigarettes with flavorings that simulate the sweet taste of fruit, candy and other sugary foods and beverages are widely available, commonly used and are frequently cited as a reason for the persistent use of e-cigarettes. During nicotine withdrawal, sweet flavors have been shown to reduce nicotine withdrawal symptoms. Additionally, a recent USC TCORS (Tobacco Center of Regulatory Science) administrative supplement study conducted at the University of Southern California (USC) Health, Emotion, and Addiction Laboratory (USC-HEAL) found that sweet-flavored solutions enhanced the appeal of e-cigarettes, independent of nicotine. However, the impact of e-cigarette flavorings on nicotine withdrawal symptoms is currently unknown. This behavioral pharmacology laboratory experiment will assess whether sweet (vs. non-sweet) flavored e-cigarette solutions reduce tobacco withdrawal symptoms and motivation to smoke among 40 smokers interested in trying e-cigarettes (for the first time) following 16-hours of nicotine abstinence. At each visit, participants will complete a standardized e-cigarette administration procedure, as developed in our prior work, in which flavor will be manipulated in a double-blind, cross-over, counterbalanced design. Following the e-cigarette administration, participants will complete: 1) self-report measures of nicotine withdrawal symptoms; 2) physiological measurements and 3) a behavioral task that measures participants' ability to resist the desire to resume smoking under conditions in which it is advantageous to remain abstinent (i.e., monetary payment for each successive 5-min increment in which smoking is delayed). The study's experimental design will provide evidence of the causal effects of e-cigarette flavorings on a putatively critical factor for determining whether smokers continue e-cigarette use after initial trial-the ability of a product to suppress withdrawal and motivation to smoke during periods of tobacco deprivation.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: