E Cigarette UsePhase 4NCT07786896
Evaluation of Dependence and Nicotine Replacement Therapy-Supported Cessation Efforts Among Regular Electronic Cigarette Use
A Phase 4 study testing Nicotine Replacement Therapies and Brief Behavioral Counseling in people with E Cigarette Use and Cessation, Tobacco, run by West Virginia University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- E Cigarette Use, Cessation, Tobacco, Cessation, Nicotine
- What is being tested?
- Nicotine Replacement Therapies and Brief Behavioral Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2026to 30 Jun 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
East Carolina University
Greenville, North Carolina, 27858
Eric K Soule, PhD, MPH, 252-328-4637, soulee18@ecu.edu
West Virginia University, Life Sciences Building
Morgantown, West Virginia, 26505
Melissa D Blank, Ph.D, 7179160447 ext. 304-293-0551, melissa.blank@mail.wvu.edu
Melissa D Blank, Ph.D
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- E Cigarette Use, Cessation, Tobacco, Cessation, Nicotine
- Being tested
- Nicotine Replacement Therapies, Brief Behavioral Counseling
- Keywords
- Nicotine Replacement Therapy (NRT), Electronic Cigarette (E-cigarette, ECIG, ENDs), Nicotine/Tobacco Withdrawal Syndrome, Nicotine/Tobacco Cessation, ECIG Cessation, Nicotine craving
- Medical subject headings
- Vaping, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine Replacement TherapiesDrug
Also called NRT, Nicotine Patch, Nicotine Lozenge
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).
Brief Behavioral CounselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Drug: Nicotine Replacement Therapies; Behavioral: Brief Behavioral Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline (i.e., Day 1) through study completion, an average of 10 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for E Cigarette UseStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Collaborators
- East Carolina University, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Melissa Blank, West Virginia University
- Investigators
- Melissa D Blank, Ph.D, Principal investigator, West Virginia UniversityEric E Soule, Ph.D, Principal investigator, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07786896
- Sponsor's protocol ID
- R15DA059750
- Other IDs
- R15DA059750
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dependence and Nicotine Replacement Therapy-Supported Cessation Efforts Among Regular Electronic Cigarette Use
- ClinicalTrials.gov ID
- NCT07786896
- Acronym / sponsor ID
- R15DA059750
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Collaborators
- East Carolina University, National Institute on Drug Abuse (NIDA)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Behavioral Counseling | Active comparator | Behavioral: Brief Behavioral CounselingParticipants will receive brief behavioral counseling on quitting e-cigarettes, including information about the risks of vaping, strategies for quitting, and ways to prevent relapse. |
| Brief Behavioral Counseling + NRT | Experimental | Drug: Nicotine Replacement Therapies, Behavioral: Brief Behavioral CounselingParticipants 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). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine Replacement TherapiesAlso: NRT, Nicotine Patch, Nicotine LozengeCombination 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). | Drug | Brief Behavioral Counseling + NRT |
| Brief Behavioral CounselingParticipants 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. | Behavioural | Brief Behavioral Counseling, Brief Behavioral Counseling + NRT |
Primary outcome
Subjective Measures.
Time frame: From baseline (i.e., Day 1) through study completion, an average of 10 days.
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).
Urine PG and cotinine
Time frame: From baseline (i.e., Day 1) through study completion, an average of 10 days.
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.
Exhaled CO
Time frame: From baseline (i.e., Day 1) through study completion, an average of 10 days.
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.
Behavioral measures
Time frame: From baseline (i.e., Day 1) through study completion, an average of 10 days.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melissa D Blank, Ph.D principal investigator
West Virginia University
Eric E Soule, Ph.D principal investigator
East Carolina University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nicotine Replacement Therapies and Brief Behavioral Counseling in people with E Cigarette Use and Cessation, Tobacco, run by West Virginia University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melissa D Blank, Ph.D (304-293-0551, melissa.blank@mail.wvu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Measures. (time frame: From baseline (i.e., Day 1) through study completion, an average of 10 days.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.