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Clinical Trials/NCT03098004
NCT03098004CompletedNot Applicable

Effects of Electronic Cigarettes on Nicotine Withdrawal Among Smokers

University of Southern California2 sites in 1 country37 target enrollmentStarted: January 1, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
37
Locations
2
Primary Endpoint
Positive Affect Negative Affect Schedule

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Other
Masking
Single (Participant)

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Positive Affect Negative Affect Schedule

Time Frame: 4 hours

The 10-item Positive Affect Negative Affect Schedule (PANAS-SF) will be used to measure positive and negative affect.

The Minnesota Nicotine withdrawal Scale

Time Frame: 4 hours

The Minnesota Nicotine withdrawal Scale (MNWS) measures 11 nicotine withdrawal symptoms on 6-point response scales.

Secondary Outcomes

  • Wisconsin Smoking Withdrawal Scale(4 hours)
  • Questionnaire of Smoking Urges(4 hours)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Adam Leventhal

Professor

University of Southern California

Study Sites (2)

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