NCT06066996

Evaluation of the Electronic Cigarette Withdrawal Syndrome

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

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.

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 exclusively use e-cigarettes will undergo monitored e-cigarette abstinence over seven days (1 week) in a residential unit. The investigators will evaluate the contribution of nicotine to withdrawal expression by assigning participants to one of three conditions: active nicotine patch, placebo patch control, or no patch to control for expectancies. Standardized behavioral and biological measures associated with withdrawal including patient report, cognitive task performance, and biometrics will be collected throughout to establish a rigorous timecourse of withdrawal and evaluate the contribution of nicotine to these symptoms.

Conditions

• E-cigarette Use
• Withdrawal

Interventions

Type	Name	Description
DRUG	Transdermal Nicotine Patch	Blinded Nicotine Patch
DRUG	Placebo Nicotine Patch	Blinded Patch with No Nicotine

Timeline

• Start date: 2023-11-28
• Primary completion: 2028-06-30
• Completion: 2028-06-30
• First posted: 2023-10-04
• Last updated: 2025-07-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study