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

NCT07786896 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: R15DA059750
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Nicotine Replacement Therapy (NRT); Electronic Cigarette (E-cigarette, ECIG, ENDs); Nicotine/Tobacco Withdrawal Syndrome; Nicotine/Tobacco Cessation; ECIG Cessation; Nicotine craving

Outcome Measures

Primary Outcomes (4)

• Subjective Measures.

  Minnesota Nicotine Withdrawal Scale (MNWS): The MNWS (Hughes \& Hatsukami, 1986) assesses withdrawal among smokers, and consists of 11 visual analog scale items (0-100) which will be adapted for ECIG use (e.g., "Urges to vape"). Questionnaire of Smoking Urges-Brief (QSU-Brief): This measure consists of 10 Likert-scale items that range from 0 (strongly disagree) to 6 (strongly agree) (Cox et al., 2001). All statements will be adapted for ECIG use (e.g., All I want right now is a vape/e-cigarette), and collapsed into two factors defined by factor analysis: intention to vape (0-30) and anticipation of relief from withdrawal (0-24). Direct Effects of Nicotine (DEN): The DEN consists of visual analog scale items (0-100) that can be used to assess NRT side effects (e.g., dizzy, lightheaded, nauseous).

  From baseline (i.e., Day 1) through study completion, an average of 10 days.

• Urine PG and cotinine

  Urine samples will confirm use of and/or abstinence from the products assigned within each condition. Importantly, change in PG urine levels has been shown previously to discriminate ECIG users who have versus have not been abstinent (Hiler et al., 2020). Samples will be stored at -70oC until shipment to the Bioanalytical Shared Resource Laboratory at Virginia Commonwealth University (see Halquist LOS). Approximately 1 mL of urine is needed for each sample for testing of both cotinine and PG, the analytic methods for which are reported in detail elsewhere (Naidong et al., 2001 and Nanco et al., 2019, respectively). Both methods rely on liquid chromatography-tandem mass spectrometry analysis preceded by a validated extraction method (Cappendijk et al., 2010). The limit of quantification is 1.0 ng/ml for cotinine and 0.0005 ng/mL for PG.

  From baseline (i.e., Day 1) through study completion, an average of 10 days.

• Exhaled CO

  Breath samples collected at all in-person visits will confirm abstinence from smoked combustible products including tobacco and other drugs like marijuana, determined by a CO level \<7 ppm.

  From baseline (i.e., Day 1) through study completion, an average of 10 days.

• Behavioral measures

  Product counts (e.g., number of pods, number of NRT patches, number of nicotine lozenges, number of disposable ECIG devices), as well as ECIG liquid weights.

  From baseline (i.e., Day 1) through study completion, an average of 10 days.

Study Arms (2)

Brief Behavioral Counseling

ACTIVE COMPARATOR

Participants will receive brief behavioral counseling on quitting e-cigarettes, including information about the risks of vaping, strategies for quitting, and ways to prevent relapse.

Behavioral: Brief Behavioral Counseling

Brief Behavioral Counseling + NRT

EXPERIMENTAL

Participants will receive brief behavioral counseling on quitting e-cigarettes, including information about the risks of vaping, strategies for quitting, and ways to prevent relapse. Participants will use nicotine patches (21 mg patch) and lozenges (2 and 4 mg).

Drug: Nicotine Replacement Therapies; Behavioral: Brief Behavioral Counseling

Interventions

Nicotine Replacement Therapies DRUG

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).

Also known as: NRT, Nicotine Patch, Nicotine Lozenge

Brief Behavioral Counseling + NRT

Brief Behavioral Counseling BEHAVIORAL

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.

Brief Behavioral Counseling; Brief Behavioral Counseling + NRT

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants will be at least 21 years of age
• Report 5+ days per week of using a nicotine-containing ECIG that is a non-refillable pod-style (e.g., JUUL, Vuse Alto) or modern disposable (e.g., Elf Bar, PuffBar) for the past 6+ months.
• Report smoking either \<100 lifetime cigarettes, or \>100 lifetime cigarettes but no regular smoking (some days or everyday) in the past year.
• Current ECIG use will be confirmed via a semi-quantitative urinary cotinine value \> 4 (NicAlert), and current non-smoking status will be confirmed via an expired air CO level \<7ppm.
• Must report an interest in quitting ECIGs within the next 1-6 months (Contemplation or Preparation Stage of Change; DiClemente et al 1991), but no use of pharmacotherapy (e.g., NRT, varenicline) within the past year.

You may not qualify if:

• Preference for ECIG liquid containing a substance other than nicotine (e.g., THC, cannabidiol)
• Use of THC/cannabis \>15 days in past month, or being unwilling or unable to abstain from THC/cannabis during study conditions.
• Use of non-cigarette tobacco (e.g., cigars, smokeless, hookah) on more than 5 days in the past month
• Uncontrolled medical or psychiatric conditions, positive toxicology for illicit substances (e.g., cocaine, opiates, amphetamine) except THC
• Alcohol use \>20 days in past month
• Breastfeeding or positive pregnancy test.

Sponsors & Collaborators

• West Virginia University: lead
• East Carolina University: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

East Carolina University

Greenville, North Carolina, 27858, United States

Location

West Virginia University, Life Sciences Building

Morgantown, West Virginia, 26505, United States

Location

MeSH Terms

Conditions

Vaping; Tobacco Use Cessation

Interventions

Nicotine Replacement Therapy; Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Smoking; Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Melissa D Blank, Ph.D

  West Virginia University

  PRINCIPAL INVESTIGATOR

• Eric E Soule, Ph.D

  East Carolina University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa D Blank, Ph.D

CONTACT

304-293-0551; melissa.blank@mail.wvu.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Principle Investigator

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 26, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)