Effects of e-Cigarettes on Nicotine Withdrawal

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Electronic Cigarettes on Nicotine Withdrawal Among Smokers

Conditions
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Electronic Cigarettes

Intervention / Treatment
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* Other: e-Cigarette


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sweet-Flavored e-Cigarette<br>Participants will self-administer a sweet-flavored e-cigarette containing 3 mg/mL of nicotine. | Other: e-Cigarette<br>* Participants will self-administer an experimenter-provided e-cigarette.<br>|
| Active Comparator: Tobacco-Flavored e-Cigarette<br>Participants will self-administer a tobacco-flavored e-cigarette containing 3 mg/mL of nicotine. | Other: e-Cigarette<br>* Participants will self-administer an experimenter-provided e-cigarette.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive Affect Negative Affect Schedule | The 10-item Positive Affect Negative Affect Schedule (PANAS-SF) will be used to measure positive and negative affect. | 4 hours | 
| The Minnesota Nicotine withdrawal Scale | The Minnesota Nicotine withdrawal Scale (MNWS) measures 11 nicotine withdrawal symptoms on 6-point response scales. | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wisconsin Smoking Withdrawal Scale | Additional withdrawal symptoms (e.g., hunger, concentration problems) will be measured with the Wisconsin Smoking Withdrawal Scale (WSWS). | 4 hours | 
| Questionnaire of Smoking Urges | 10-item Brief Questionnaire of Smoking Urges will assess desire, intention, urge and need to smoke cigarettes. | 4 hours |