Evaluation of Dependence and Nicotine Replacement Therapy-Supported Cessation Efforts Among Regular Electronic Cigarette Use

Summary

This study aims to improve understanding of how people who use electronic cigarettes (ECIGs or e-cigarettes) respond when they try to stop using them and whether nicotine replacement therapy (NRT) can make that process easier. NRT products, such as nicotine patches and lozenges, are approved medications that help reduce nicotine withdrawal symptoms by providing nicotine without the harmful chemicals found in tobacco smoke or e-cigarette aerosol.

The study has two parts. During the first part, all participants will continue using their own e-cigarettes as they normally would for three days. This allows researchers to understand each participant's typical e-cigarette use before any changes are made.

In the second part, participants will be randomly assigned to one of two groups. One group will receive nicotine replacement therapy, including nicotine patches and nicotine lozenges, to use for up to seven days. The first two days are intended to help participants adjust to the medications while they continue using their e-cigarettes. During the following five days, participants will be encouraged to stop using their e-cigarettes while continuing to use the nicotine replacement products. The other group will be asked to stop using all nicotine and tobacco products for five days without receiving nicotine replacement therapy.

Throughout the study, researchers will regularly ask participants about their cravings, withdrawal symptoms, motivation to quit, and experiences using or not using e-cigarettes. Researchers will also measure how much participants use their e-cigarettes and assess exposure to nicotine and other chemicals.

The information collected will help researchers better understand whether nicotine replacement therapy can support people who are trying to stop using e-cigarettes. It will also help identify the most accurate ways to measure e-cigarette use and abstinence in future research, which may improve the development and evaluation of treatments for e-cigarette dependence.

Conditions

• E Cigarette Use
• Cessation, Tobacco
• Cessation, Nicotine

Interventions

DRUG

Nicotine Replacement Therapies

Combination NRT (long-acting patch + fast-acting lozenge or gum) was observed to be safe and potentially effective for promoting ECIG cessation. Consequently, participants assigned to the NRT condition will be given patches+lozenges in their choice of flavor. The doses administered will be based on how soon after awakening that they report vaping: \<30 min (21 mg patch; 4 mg lozenge) or \>30 min (21 mg patch; 2 mg lozenge).

BEHAVIORAL

Brief Behavioral Counseling

Participants in both conditions will experience a brief behavioral support intervention based on the Gold Standard Program for Tobacco Cessation. The components of this program include motivational conversation, education on the risks of vaping, participants' thoughts about quitting vaping, challenges that may occur when attempting to quit vaping, and strategies to prevent relapse.

Sponsors & Collaborators

• East Carolina University

  collaborator OTHER

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• West Virginia University

  lead OTHER

Principal Investigators

• Melissa D Blank, Ph.D · West Virginia University

• Eric E Soule, Ph.D · East Carolina University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2028-06-30

Completion

2028-06-30

FDA Drug

Yes

Countries

• United States

Study Locations