Effects of e-Cigarettes on Nicotine Withdrawal

NCT03098004 | Completed

• 1 other identifier: HS-16-00630
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Electronic Cigarettes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Wisconsin Smoking Withdrawal Scale

  4 hours

• Questionnaire of Smoking Urges

  4 hours

Study Arms (2)

Sweet-Flavored e-Cigarette

EXPERIMENTAL

Participants will self-administer a sweet-flavored e-cigarette containing 3 mg/mL of nicotine.

Other: e-Cigarette

Tobacco-Flavored e-Cigarette

ACTIVE COMPARATOR

Participants will self-administer a tobacco-flavored e-cigarette containing 3 mg/mL of nicotine.

Other: e-Cigarette

Interventions

e-Cigarette OTHER

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

Sweet-Flavored e-Cigarette; Tobacco-Flavored e-Cigarette

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

USC Health, Emotion and Addiction Laboratory

Los Angeles, California, 90032, United States

Location

MeSH Terms

Conditions

Vaping

Interventions

Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Smoking; Behavior

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: March 31, 2017
• Study Start: January 1, 2017
• Primary Completion: May 31, 2019
• Study Completion: August 31, 2019
• Last Updated: July 11, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)