Evaluation of the Electronic Cigarette Withdrawal Syndrome

Recruiting now · Early Phase 1 · Has a placebo group

Conditions studied: E-cigarette Use, Withdrawal

In brief

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.

Key facts

Study ID

NCT06066996

Run by

Johns Hopkins University

People needed

150

Starts

2023-11-28

Expected to finish

2028-06-30

Last updated by the study team

2026-07-15

Who can join

Age: 21 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Behavioral Pharmacology Research Unit — Baltimore, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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