Trials / Completed
CompletedNCT03098004
Effects of e-Cigarettes on Nicotine Withdrawal
Effects of Electronic Cigarettes on Nicotine Withdrawal Among Smokers
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 37 (actual)
- Sponsor
- University of Southern California · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | e-Cigarette | Participants will self-administer an experimenter-provided e-cigarette. |
Timeline
- Start date
- 2017-01-01
- Primary completion
- 2019-05-31
- Completion
- 2019-08-31
- First posted
- 2017-03-31
- Last updated
- 2023-07-11
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03098004. Inclusion in this directory is not an endorsement.