Status:
RECRUITING
Evaluation of the Electronic Cigarette Withdrawal Syndrome
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
E-cigarette Use
Withdrawal
Eligibility:
All Genders
21-55 years
Phase:
EARLY_PHASE1
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 o...
Detailed Description
This project will use a rigorous residential laboratory design to evaluate e-cigarette withdrawal expression and experimentally determine the role of nicotine in this syndrome. Healthy adults who excl...
Eligibility Criteria
Inclusion
- 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
- Penn State E-cigarette Dependence (PSED) score \>=4, indicating mild dependence or greater
- have an interest in reducing e-cigarette use
- 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
- 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)
Exclusion
Key Trial Info
Start Date :
November 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06066996
Start Date
November 28 2023
End Date
June 30 2028
Last Update
July 14 2025
Active Locations (1)
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1
Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States, 21224