NCT06066996 · Johns Hopkins University
Evaluation of the Electronic Cigarette Withdrawal Syndrome
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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
Exclusion criteria
- 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
- positive pregnancy test
- currently using a nicotine/tobacco cessation product
- seizure disorder or traumatic brain injury (TBI)
Where
- Baltimore, Maryland
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 14, 2025 · Source of record for eligibility and locations