Effects of e-Cigarettes on Nicotine Withdrawal

Effects of Electronic Cigarettes on Nicotine Withdrawal Among Smokers

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.

Study Overview

• Status: Completed
• Conditions: Electronic Cigarettes
• Intervention / Treatment: Other: e-Cigarette

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 Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90032
      • USC Health, Emotion and Addiction Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): May 31, 2019
• Study Completion (Actual): August 31, 2019

Study Registration Dates

• First Submitted: March 22, 2017
• First Submitted That Met QC Criteria: March 27, 2017
• First Posted (Actual): March 31, 2017

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 7, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HS-16-00630

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No