An Early Phase 1 interventional study of Transdermal Nicotine Patch and Placebo Nicotine Patch in E-cigarette Use and Withdrawal, sponsored by Johns Hopkins University. Recruiting at 1 site in United States. Open to participants aged 21 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by Johns Hopkins University · Early Phase 1, Interventional, and Basic science
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.
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.
402 studies on the registry are indexed under Vaping; 95 are open to participants now.
This study's planned enrollment of 150 is above the median of 79 across 322 interventional studies indexed under Vaping.
Browse Vaping studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
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.
Drug: Transdermal Nicotine Patch
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.
Drug: Placebo Nicotine Patch
Participants assigned to this condition will not receive a patch.
Blinded Nicotine Patch
Blinded Patch with No Nicotine
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, every 4 hours up to 16 hours
Total sleep time
Total time sleeping in minutes measured using actigraphy and unobtrusive EEG.
Time frame: 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.
Time frame: 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.
Time frame: Nightly up to seven days
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.
Time frame: 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.
Time frame: Baseline, every 4 hours up to 16 hours
Return to Use
Return to e-cigarette use at the one week follow-up.
Time frame: Day 14
Started Nov 2023 (actual). Primary completion is estimated for Jun 2028, 55 months after the start.
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Studies of the drug tested here: Nicotine