A Phase 4 interventional study of Nicotine Replacement Therapies and Brief Behavioral Counseling in E Cigarette Use, Cessation, Tobacco and Cessation, Nicotine, sponsored by West Virginia University. Not yet recruiting at 2 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by West Virginia University · Phase 4, Interventional, and Treatment
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.
Nicotine replacement therapy (NRT) is a pharmacotherapy for smoking cessation approved by the Federal Drug Administration (FDA). Most NRT products are available over the counter, making them easily accessible to not only cigarette smokers but also electronic cigarette (ECIG) users. Up to 40% of sampled ECIG users have endorsed use of a pharmacotherapy such as NRT during an ECIG quit attempt ; however, the ability of NRT to promote ECIG cessation has been evaluated in only a two pilot studies. In these studies, 40.0-42.9% of ECIG users reported ECIG abstinence after one or 6 months of NRT use. A major limitation of these studies is the reliance on self-reports of ECIG abstinence.
Unlike combustible tobacco products, ECIGs produce minimal carbon monoxide (CO). Consequently, exhaled CO tests used to confirm acute abstinence from products like cigarettes cannot be used for ECIG abstinence. Instead, researchers rely on measurement of nicotine or its metabolite cotinine, both of which can be detected in various biological fluids to confirm acute (e.g., hours) or longer-term (e.g., days) abstinence from ECIGs. As has been highlighted by our previous work, however, the assays required for these measures are not only costly and burdensome, they also are unable to distinguish use of ECIGs from other products like cigarettes or NRT. These challenges have led to the development of assays for detecting propylene glycol (PG), a primary ingredient in ECIG liquid. Urine PG concentrations are significantly higher in regular ECIG users relative to non-tobacco users (25.6 vs 9.8 mcg/ml, respectively), as well as that PG concentrations for ECIG users are reduced to non-tobacco user levels (9.7 mcg/ml) following 12 hours of ECIG abstinence. These data show that PG can be measured in urine, and urine PG levels can be used to discriminate ECIG users from non-users as well as verify short-term ECIG abstinence.
There is need for a greater understanding of ECIG dependence and evaluation of approaches to support ECIG cessation among non-current smoking ECIG users. Data from the proposed project will increase understanding of ECIG dependence, including indicators unique to ECIG use relative to cigarette smoking that are not captured in extant ECIG dependence measures. This project also will provide data on how NRT may support ECIG cessation, as well as an evaluation of approaches that can be used to verify ECIG use behaviors and abstinence beyond user self-report. These latter data are urgently needed for the development of best practices for supporting ECIG cessation. Thus, successful completion of this project will ultimately support efforts to prevent negative health outcomes associated with ECIG dependence and use.
Aim 2 involves a between-subjects study with two phases. Phase I involves a 3-day baseline period during which all participants will use their own ECIG ad lib. Phase II involves randomization to one of two study conditions: NRT or abstinence. Those assigned to the NRT condition (n=50) will be provided with nicotine patches (21 mg) and lozenges (2 or 4mg) to use ad lib for up to 7 days (2 days of pre-loading; 5 days of intervention). Those assigned to the abstinence condition (n=50) will be asked to abstain from all nicotine/tobacco products for 5 days. Both phases will include regular assessment of quit motivation, subjective effects, product use, and toxicant exposure. Aim 3 involves using some of the outcomes from Aim 2 (i.e., objective and subjective measures of ECIG use) to determine which methods offer the best measurement of ECIG use/abstinence.
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Exclusion Criteria:
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
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
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
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.
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From baseline (i.e., Day 1) through study completion, an average of 10 days.
Plan to share: No
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Studies of the drug tested here: Nicotine Patch