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Recruiting EARLY_Phase 1 NCT06066996

Evaluation of the Electronic Cigarette Withdrawal Syndrome

Trial Parameters

Condition E-cigarette Use
Sponsor Johns Hopkins University
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 150
Sex ALL
Min Age 21 Years
Max Age 55 Years
Start Date 2023-11-28
Completion 2028-06-30
Interventions
Transdermal Nicotine PatchPlacebo Nicotine Patch

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.

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 wou

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