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RecruitingEarly Phase 1NCT06066996

Evaluation of the Electronic Cigarette Withdrawal Syndrome

Evaluation of the Electronic Cigarette Withdrawal Syndrome: Mechanistic Targets for Intervention

Sponsor

Johns Hopkins University

Enrollment

150 participants

Start Date

Nov 28, 2023

Study Type

INTERVENTIONAL

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

Min Age: 21 YearsMax Age: 55 Years

Inclusion Criteria10

  • 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 Criteria9

  • 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)

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Interventions

DRUGTransdermal Nicotine Patch

Blinded Nicotine Patch

DRUGPlacebo Nicotine Patch

Blinded Patch with No Nicotine

Locations(1)

Behavioral Pharmacology Research Unit

Baltimore, Maryland, United States

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NCT06066996