RecruitingEarly Phase 1

Evaluation of the Electronic Cigarette Withdrawal Syndrome

United States150 participantsStarted 2023-11-28

Plain-language 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.

Who can participate

Age range

21 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Hughes-Hatsukami Withdrawal Scale

Timeframe: Baseline, every 4 hours up to 16 hours

Change in Smoking urges as assessed by the Tiffany-Drobes Questionnaire of Smoking Urges (QSU) Brief

Timeframe: Baseline, every 4 hours up to 16 hours

Change in Positive and Negative Affect Schedule (PANAS)

Timeframe: Baseline, every 4 hours up to 16 hours

Change in Conners' Continuous Performance Task (CPT)

Timeframe: Baseline, every 4 hours up to 16 hours

Change in Memory as assessed by the N-Back

Timeframe: Baseline, every 4 hours up to 16 hours

Total sleep time

Timeframe: Nightly up to seven days

Total time spent in Rapid eye movement (REM) sleep

Timeframe: Nightly up to seven days

Trial details

NCT IDNCT06066996

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-06-30

Contact for this trial

Justin Strickland, Ph.D.

4105501975 jstric14@jhmi.edu

View on ClinicalTrials.gov More E-cigarette Use trials

Who can participate

Age range

21 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

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

What they're measuring

Change in Hughes-Hatsukami Withdrawal Scale

Timeframe: Baseline, every 4 hours up to 16 hours

Change in Smoking urges as assessed by the Tiffany-Drobes Questionnaire of Smoking Urges (QSU) Brief

Timeframe: Baseline, every 4 hours up to 16 hours

Change in Positive and Negative Affect Schedule (PANAS)

Timeframe: Baseline, every 4 hours up to 16 hours

Change in Conners' Continuous Performance Task (CPT)

Timeframe: Baseline, every 4 hours up to 16 hours

Change in Memory as assessed by the N-Back

Timeframe: Baseline, every 4 hours up to 16 hours

Total sleep time

Timeframe: Nightly up to seven days

Total time spent in Rapid eye movement (REM) sleep

Timeframe: Nightly up to seven days