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Effects of e-Cigarettes on Nicotine Withdrawal

Effects of Electronic Cigarettes on Nicotine Withdrawal Among Smokers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03098004
Enrollment
37
Registered
2017-03-31
Start date
2017-01-01
Completion date
2019-08-31
Last updated
2023-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Electronic Cigarettes

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.

Interventions

OTHERe-Cigarette

Participants will self-administer an experimenter-provided e-cigarette.

Sponsors

University of Southern California
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. 21 years of age or older; 2. Daily cigarette smoking for at least the past two years; 3. Currently smoke \> 10 cig/day; 4. Interest in trying e-cigarettes; 5. report primarily smoking non-mentholated cigarettes.

Exclusion criteria

1. Current use of medications that impact withdrawal or smoking (e.g., bupropion, varenicline, nicotine replacement, anti-depressants, anxiolytics); 2. Prior use of e-cigarettes (i.e., self-report \> 10 puffs lifetime, use on more than two occasions, purchased own device); 3. breath carbon monoxide (CO) \< 10 at intake; 4. pregnancy/breastfeeding; and 5. daily use of other tobacco products (e.g., hookah, cigars).

Design outcomes

Primary

MeasureTime frameDescription
Positive Affect Negative Affect Schedule4 hoursThe 10-item Positive Affect Negative Affect Schedule (PANAS-SF) will be used to measure positive and negative affect.
The Minnesota Nicotine withdrawal Scale4 hoursThe Minnesota Nicotine withdrawal Scale (MNWS) measures 11 nicotine withdrawal symptoms on 6-point response scales.

Secondary

MeasureTime frameDescription
Wisconsin Smoking Withdrawal Scale4 hoursAdditional withdrawal symptoms (e.g., hunger, concentration problems) will be measured with the Wisconsin Smoking Withdrawal Scale (WSWS).
Questionnaire of Smoking Urges4 hours10-item Brief Questionnaire of Smoking Urges will assess desire, intention, urge and need to smoke cigarettes.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026