Evaluation of the Electronic Cigarette Withdrawal Syndrome
- Conditions
- E-cigarette UseWithdrawal
- Interventions
- Registration Number
- NCT06066996
- Lead Sponsor
- Johns Hopkins University
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Transdermal Nicotine Patch Transdermal Nicotine Patch 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. Transdermal Placebo Patch Placebo 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.
- Primary Outcome Measures
Name Time Method Change in Hughes-Hatsukami Withdrawal Scale 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 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) 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.
Total sleep time Nightly up to seven days Total time sleeping in minutes measured using actigraphy and unobtrusive EEG.
Change in Memory as assessed by the N-Back 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 time spent in Rapid eye movement (REM) sleep Nightly up to seven days Total time sleeping in minutes in REM stage measured using actigraphy and unobtrusive EEG.
Change in Conners' Continuous Performance Task (CPT) 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.
Wake after sleep onset (WASO) 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.
- Secondary Outcome Measures
Name Time Method Change in E-Cigarette Demand Intensity Baseline, every 4 hours up to 16 hours 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.
Return to Use Day 14 Return to e-cigarette use at the one week follow-up.
Change in E-Cigarette Demand Elasticity Baseline, every 4 hours up to 16 hours 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.
Trial Locations
- Locations (1)
Behavioral Pharmacology Research Unit
🇺🇸Baltimore, Maryland, United States