Evaluation of the Electronic Cigarette Withdrawal Syndrome

Launched by JOHNS HOPKINS UNIVERSITY · Sep 28, 2023

Keywords

ClinConnect Summary

This clinical trial is examining the withdrawal symptoms experienced by people who regularly use e-cigarettes when they stop using them for a period of time. The researchers want to better understand how nicotine, the addictive substance in e-cigarettes, affects these withdrawal symptoms. The trial is currently looking for participants between the ages of 21 and 55 who have been using nicotine-containing e-cigarettes daily for at least six months and are generally in good health. Participants should also be interested in reducing their e-cigarette use.

If you join the study, you will go through a monitored period where you will stop using e-cigarettes, and researchers will observe how you feel during this time. They will check your health and conduct some tests to make sure you are eligible and safe to participate. This study aims to help improve support for people trying to quit e-cigarettes, so your experience could contribute to better understanding and treatment options in the future.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • 1. 21-55 years old
• • 2. good general health as reviewed by study medical team
• • 3. vital signs in normal range as reviewed by study medical team
• • 4. negative urine test for illicit drug use (excluding THC) and negative breath alcohol test
• • 5. daily use of a nicotine-containing e-cigarette for at least 6 months
• • 6. no regular use of other tobacco products (e.g., smokeless products) for at least 6 months
• • 7. urine cotinine \>100ng/mL (i.e., recommended cutoff for confirming current nicotine use)
• • 8. exhaled breath carbon monoxide (CO) \<6ppm
• • 9. Penn State E-cigarette Dependence (PSED) score \>=4, indicating mild dependence or greater
• • 10. have an interest in reducing e-cigarette use
• Exclusion criteria:
• • 1. psychoactive drug use (aside from cannabis, nicotine, alcohol, caffeine) in past month
• • 2. current use of over-the-counter (OTC) or prescription medications that may impact safety
• • 3. use cannabis \>2 times per week
• • 4. history of or current significant medical condition that would impact participation or safety according to the study investigators and medical staff
• • 5. 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
• • 6. enrollment in another trial
• • 7. positive pregnancy test
• • 8. currently using a nicotine/tobacco cessation product
• • 9. seizure disorder or traumatic brain injury (TBI)