Overview

Evaluation of the Electronic Cigarette Withdrawal Syndrome

Status:
Recruiting

Trial end date:
2028-08-31

Target enrollment:
0

Participant gender:
All

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.

Phase:

Early Phase 1

Accepts Healthy Volunteers?

Accepts Healthy Volunteers

Details

Lead Sponsor:

Johns Hopkins University

Collaborator:

National Institute on Drug Abuse (NIDA)

Treatments:

Nicotine

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)