Evaluating withdrawal symptoms in e-cigarette users

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

This study is testing how withdrawal symptoms affect people who only use e-cigarettes when they stop using them for a week, while trying different types of nicotine patches to see how they help.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 21 Years to 55 Years
• Sex: All
• Sponsor: Johns Hopkins University (other)
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT06066996 on ClinicalTrials.gov

What this trial studies

This project aims to rigorously assess the withdrawal symptoms experienced by exclusive e-cigarette users during a one-week monitored abstinence period. Participants will be assigned to one of three conditions: an active nicotine patch, a placebo patch, or no patch, to evaluate the role of nicotine in withdrawal expression. The study will utilize a residential laboratory design, collecting both behavioral and biological measures to establish a detailed timeline of withdrawal symptoms and the impact of nicotine. The findings could provide insights into the nature of e-cigarette withdrawal and inform cessation strategies.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 21-55 who have been exclusive e-cigarette users for at least six months and are interested in reducing their e-cigarette use.

Not a fit: Patients who regularly use other tobacco products or have significant medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of e-cigarette withdrawal, potentially leading to improved cessation methods for users.

How similar studies have performed: While there have been studies on nicotine withdrawal, this specific approach focusing on e-cigarette users is relatively novel and untested.

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)

Where this trial is running

Baltimore, Maryland

• Behavioral Pharmacology Research Unit — Baltimore, Maryland, United States (RECRUITING)

Study contacts

• Principal investigator: Justin Strickland, Ph.D. — Johns Hopkins University
• Study coordinator: Justin Strickland, Ph.D.

Conditions: E-cigarette Use, Withdrawal