E-cigarette UseEarly Phase 1NCT06066996
Evaluation of the Electronic Cigarette Withdrawal Syndrome
A Early Phase 1 study testing Transdermal Nicotine Patch in people with E-cigarette Use and Withdrawal, run by Johns Hopkins University at 1 site in United States.
Trial summary
The goal of this project is to rigorously evaluate the nature of e-cigarette withdrawal in exclusive e-cigarette users during a monitored abstinence period and the role of nicotine in the expression of this withdrawal syndrome. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- E-cigarette Use, Withdrawal
- What is being tested?
- Transdermal Nicotine Patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2023to 30 Jun 2028
- Phase
- Early Phase 1
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 21-55 years old
- good general health as reviewed by study medical team
- vital signs in normal range as reviewed by study medical team
- negative urine test for illicit drug use (excluding THC) and negative breath alcohol test
- daily use of a nicotine-containing e-cigarette for at least 6 months
- no regular use of other tobacco products (e.g., smokeless products) for at least 6 months
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- urine cotinine >100ng/mL (i.e., recommended cutoff for confirming current nicotine use)
- exhaled breath carbon monoxide (CO) <6ppm
- Penn State E-cigarette Dependence (PSED) score >=4, indicating mild dependence or greater
- have an interest in reducing e-cigarette use
Who cannot join
- psychoactive drug use (aside from cannabis, nicotine, alcohol, caffeine) in past month
- current use of over-the-counter (OTC) or prescription medications that may impact safety
- use cannabis >2 times per week
- history of or current significant medical condition that would impact participation or safety according to the study investigators and medical staff
- current psychiatric condition or substance use disorder (aside from tobacco use disorder) that would impact participation or safety according to the study investigators and medical staff
- enrollment in another trial
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- positive pregnancy test
- currently using a nicotine/tobacco cessation product
- seizure disorder or traumatic brain injury (TBI)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Behavioral Pharmacology Research Unit
Baltimore, Maryland, 21224
Justin Strickland, Ph.D., 410-550-1975, jstric14@jhmi.edu
About this study
Official title: Evaluation of the Electronic Cigarette Withdrawal Syndrome: Mechanistic Targets for Intervention
The goal of this project is to rigorously evaluate the nature of e-cigarette withdrawal in exclusive e-cigarette users during a monitored abstinence period and the role of nicotine in the expression of this withdrawal syndrome.
Read the detailed description
This project will use a rigorous residential laboratory design to evaluate e-cigarette withdrawal expression and experimentally determine the role of nicotine in this syndrome. Healthy adults who exclusively use e-cigarettes will undergo monitored e-cigarette abstinence over seven days (1 week) in a residential unit. The investigators will evaluate the contribution of nicotine to withdrawal expression by assigning participants to one of three conditions: active nicotine patch, placebo patch control, or no patch to control for expectancies. Standardized behavioral and biological measures associated with withdrawal including patient report, cognitive task performance, and biometrics will be collected throughout to establish a rigorous timecourse of withdrawal and evaluate the contribution of nicotine to these symptoms.
- Conditions
- E-cigarette Use, Withdrawal
- Being tested
- Transdermal Nicotine Patch, Placebo Nicotine Patch
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal Nicotine PatchDrug
Blinded Nicotine Patch
Placebo Nicotine PatchDrug
Blinded Patch with No Nicotine
| Study group | Role | What they receive |
|---|---|---|
| Transdermal Nicotine Patch | Experimental | Participants assigned to this condition will receive a blinded nicotine patch and will wear the patch on their upper arm, per the manufacturer's instructions. Receives: Drug: Transdermal Nicotine Patch |
| Transdermal Placebo Patch | Placebo comparator | Participants assigned to this placebo nicotine patch condition will receive a blinded patch containing 0mg of nicotine, and will wear the patch on their upper arm, per the manufacturer's instructions. Receives: Drug: Placebo Nicotine Patch |
| No Patch | No intervention | Participants assigned to this condition will not receive a patch. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hughes-Hatsukami Withdrawal Scale
The Hughes-Hatsukami Withdrawal Scale consists of 13 items presented individually on a 100mm visual analog scale. Higher scores reflect higher withdrawal (worse outcome) [range 0-32]. Measures are taken at baseline, 8am, 12pm, 4pm, and 8pm every day during the seven day residential stay.
Measured: Baseline, every 4 hours up to 16 hours
Change in Smoking urges as assessed by the Tiffany-Drobes Questionnaire of Smoking Urges (QSU) Brief
The Tiffany-Drobes QSU Brief consists of ten items, each presented on the screen as a phrase centered above seven boxes ranging from (strongly disagree) to (strongly agree). Higher scores reflect higher withdrawal (worse outcome) [range 0-70]. Measures are taken at baseline, 8am, 12pm, 4pm, and 8pm every day during the seven day residential stay.
Measured: Baseline, every 4 hours up to 16 hours
Change in Positive and Negative Affect Schedule (PANAS)
The PANAS consists of 20 items presented individually on a five-point Likert scale. Higher scores reflect more positive affect and negative affect [range 0-50]. Measures are taken at baseline, 8am, 12pm, 4pm, and 8pm every day during the seven day residential stay.
Measured: Baseline, every 4 hours up to 16 hours
Change in Conners' Continuous Performance Task (CPT)
On the CPT, participants respond to single letters appearing on their computer screen but are asked to refrain from responding to a specified letter(i.e., the letter X). Higher scores reflect more inattention. Measures are taken at baseline, 8am, 12pm, 4pm, and 8pm every day during the seven day residential stay.
Measured: Baseline, every 4 hours up to 16 hours
Change in Memory as assessed by the N-Back
On the n-back, participants decide whether each stimulus in a sequence matches the one that appeared "n" items ago. Higher scores reflect more accuracy. Measures are taken at baseline, 8am, 12pm, 4pm, and 8pm every day during the seven day residential stay.
Measured: Baseline, every 4 hours up to 16 hours
Total sleep time
Total time sleeping in minutes measured using actigraphy and unobtrusive EEG.
Measured: Nightly up to seven days
Total time spent in Rapid eye movement (REM) sleep
Total time sleeping in minutes in REM stage measured using actigraphy and unobtrusive EEG.
Measured: Nightly up to seven days
Wake after sleep onset (WASO)
Total number of minutes that a person is awake after having initially fallen asleep measured using actigraphy and unobtrusive EEG.
Measured: Nightly up to seven days
Secondary outcomes (3)
Change in E-Cigarette Demand Intensity
E-cigarette use at unconstrained price measured using a commodity purchase task. Higher scores reflect more demand (worse outcome). Measures are taken at baseline, 8am, 12pm, 4pm, and 8pm every day during the seven day residential stay.
Measured: Baseline, every 4 hours up to 16 hours
Change in E-Cigarette Demand Elasticity
Sensitivity of e-cigarette use to price measured using a commodity purchase task. Higher scores reflect more price sensitivity (better outcome). Measures are taken at baseline, 8am, 12pm, 4pm, and 8pm every day during the seven day residential stay.
Measured: Baseline, every 4 hours up to 16 hours
Return to Use
Return to e-cigarette use at the one week follow-up.
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start28 Nov 2023
- 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 Johns Hopkins 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Justin Strickland, Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06066996
- Sponsor's protocol ID
- IRB00407275
- Other IDs
- R01DA057925
- Status last verified
- Jul 2026
- First submitted
- 28 Sep 2023
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Electronic Cigarette Withdrawal Syndrome: Mechanistic Targets for Intervention
- ClinicalTrials.gov ID
- NCT06066996
- Acronym / sponsor ID
- IRB00407275
- Conditions
- E-cigarette Use, Withdrawal
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 4 Oct 2023 (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.
The goal of this project is to rigorously evaluate the nature of e-cigarette withdrawal in exclusive e-cigarette users during a monitored abstinence period and the role of nicotine in the expression of this withdrawal syndrome.
Detailed description
This project will use a rigorous residential laboratory design to evaluate e-cigarette withdrawal expression and experimentally determine the role of nicotine in this syndrome. Healthy adults who exclusively use e-cigarettes will undergo monitored e-cigarette abstinence over seven days (1 week) in a residential unit. The investigators will evaluate the contribution of nicotine to withdrawal expression by assigning participants to one of three conditions: active nicotine patch, placebo patch control, or no patch to control for expectancies. Standardized behavioral and biological measures associated with withdrawal including patient report, cognitive task performance, and biometrics will be collected throughout to establish a rigorous timecourse of withdrawal and evaluate the contribution of nicotine to these symptoms.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transdermal Nicotine Patch | Experimental | Drug: Transdermal Nicotine PatchParticipants assigned to this condition will receive a blinded nicotine patch and will wear the patch on their upper arm, per the manufacturer's instructions. |
| Transdermal Placebo Patch | Placebo comparator | Drug: Placebo Nicotine PatchParticipants assigned to this placebo nicotine patch condition will receive a blinded patch containing 0mg of nicotine, and will wear the patch on their upper arm, per the manufacturer's instructions. |
| No Patch | No intervention | –Participants assigned to this condition will not receive a patch. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 21-55 years old
- good general health as reviewed by study medical team
- vital signs in normal range as reviewed by study medical team
- negative urine test for illicit drug use (excluding THC) and negative breath alcohol test
- daily use of a nicotine-containing e-cigarette for at least 6 months
Key exclusion criteria (9 listed)
- psychoactive drug use (aside from cannabis, nicotine, alcohol, caffeine) in past month
- current use of over-the-counter (OTC) or prescription medications that may impact safety
- use cannabis >2 times per week
- history of or current significant medical condition that would impact participation or safety according to the study investigators and medical staff
- current psychiatric condition or substance use disorder (aside from tobacco use disorder) that would impact participation or safety according to the study investigators and medical staff
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 |
|---|---|---|
| Transdermal Nicotine PatchBlinded Nicotine Patch | Drug | Transdermal Nicotine Patch |
| Placebo Nicotine PatchBlinded Patch with No Nicotine | Drug | Transdermal Placebo Patch |
Primary outcome
Change in Hughes-Hatsukami Withdrawal Scale
Time frame: Baseline, every 4 hours up to 16 hours
The Hughes-Hatsukami Withdrawal Scale consists of 13 items presented individually on a 100mm visual analog scale. Higher scores reflect higher withdrawal (worse outcome) [range 0-32]. Measures are taken at baseline, 8am, 12pm, 4pm, and 8pm every day during the seven day residential stay.
Change in Smoking urges as assessed by the Tiffany-Drobes Questionnaire of Smoking Urges (QSU) Brief
Time frame: Baseline, every 4 hours up to 16 hours
The Tiffany-Drobes QSU Brief consists of ten items, each presented on the screen as a phrase centered above seven boxes ranging from (strongly disagree) to (strongly agree). Higher scores reflect higher withdrawal (worse outcome) [range 0-70]. Measures are taken at baseline, 8am, 12pm, 4pm, and 8pm every day during the seven day residential stay.
Change in Positive and Negative Affect Schedule (PANAS)
Time frame: Baseline, every 4 hours up to 16 hours
The PANAS consists of 20 items presented individually on a five-point Likert scale. Higher scores reflect more positive affect and negative affect [range 0-50]. Measures are taken at baseline, 8am, 12pm, 4pm, and 8pm every day during the seven day residential stay.
Change in Conners' Continuous Performance Task (CPT)
Time frame: Baseline, every 4 hours up to 16 hours
On the CPT, participants respond to single letters appearing on their computer screen but are asked to refrain from responding to a specified letter(i.e., the letter X). Higher scores reflect more inattention. Measures are taken at baseline, 8am, 12pm, 4pm, and 8pm every day during the seven day residential stay.
Change in Memory as assessed by the N-Back
Time frame: Baseline, every 4 hours up to 16 hours
On the n-back, participants decide whether each stimulus in a sequence matches the one that appeared "n" items ago. Higher scores reflect more accuracy. Measures are taken at baseline, 8am, 12pm, 4pm, and 8pm every day during the seven day residential stay.
Total sleep time
Time frame: Nightly up to seven days
Total time sleeping in minutes measured using actigraphy and unobtrusive EEG.
Total time spent in Rapid eye movement (REM) sleep
Time frame: Nightly up to seven days
Total time sleeping in minutes in REM stage measured using actigraphy and unobtrusive EEG.
Wake after sleep onset (WASO)
Time frame: Nightly up to seven days
Total number of minutes that a person is awake after having initially fallen asleep measured using actigraphy and unobtrusive EEG.
3 secondary outcomes
Change in E-Cigarette Demand Intensity
Time frame: Baseline, every 4 hours up to 16 hours
Change in E-Cigarette Demand Elasticity
Time frame: Baseline, every 4 hours up to 16 hours
Return to Use
Time frame: Day 14
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 15 Jul 2026.
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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.
Justin Strickland, Ph.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Transdermal Nicotine Patch in people with E-cigarette Use and Withdrawal, run by Johns Hopkins University at 1 site 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 10 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Justin Strickland, Ph.D. (4105501975, jstric14@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hughes-Hatsukami Withdrawal Scale (time frame: Baseline, every 4 hours up to 16 hours). The study lists 8 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 15 Jul 2026.