Evaluation of the Electronic Cigarette Withdrawal Syndrome

Early Phase 1RecruitingNCT06066996

Johns Hopkins University150 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

150

Conditions

E-cigarette Use Withdrawal

Interventions

Transdermal Nicotine PatchDRUG

Blinded Nicotine Patch

Placebo Nicotine PatchDRUG

Blinded Patch with No Nicotine

Eligibility

Sex: ALLMin age: 21 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Behavioral Pharmacology Research Unit

Baltimore, Maryland, United States

RECRUITING

Outcomes

Primary Outcomes

Change in Hughes-Hatsukami Withdrawal Scale

The Hughes-Hatsukami Withdrawal Scale consists of 13 items presented individually on a 100mm visual analog scale. Higher scores reflect higher withdrawal (worse outcome) \[range 0-32\]. Measures are taken at baseline, 8am, 12pm, 4pm, and 8pm every day during the seven day residential stay.

Time frame: Baseline, every 4 hours up to 16 hours

Change in Smoking urges as assessed by the Tiffany-Drobes Questionnaire of Smoking Urges (QSU) Brief

The Tiffany-Drobes QSU Brief consists of ten items, each presented on the screen as a phrase centered above seven boxes ranging from (strongly disagree) to (strongly agree). Higher scores reflect higher withdrawal (worse outcome) \[range 0-70\]. Measures are taken at baseline, 8am, 12pm, 4pm, and 8pm every day during the seven day residential stay.

Time frame: Baseline, every 4 hours up to 16 hours

Change in Positive and Negative Affect Schedule (PANAS)

The PANAS consists of 20 items presented individually on a five-point Likert scale. Higher scores reflect more positive affect and negative affect \[range 0-50\]. Measures are taken at baseline, 8am, 12pm, 4pm, and 8pm every day during the seven day residential stay.

Time frame: Baseline, every 4 hours up to 16 hours

Change in Conners' Continuous Performance Task (CPT)

On the CPT, participants respond to single letters appearing on their computer screen but are asked to refrain from responding to a specified letter(i.e., the letter X). Higher scores reflect more inattention. Measures are taken at baseline, 8am, 12pm, 4pm, and 8pm every day during the seven day residential stay.

Time frame: Baseline, every 4 hours up to 16 hours

Change in Memory as assessed by the N-Back

On the n-back, participants decide whether each stimulus in a sequence matches the one that appeared "n" items ago. Higher scores reflect more accuracy. Measures are taken at baseline, 8am, 12pm, 4pm, and 8pm every day during the seven day residential stay.

Central Contacts

Justin Strickland, Ph.D.

CONTACT

4105501975 jstric14@jhmi.edu

Data from ClinicalTrials.gov

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Evaluation of the Electronic Cigarette Withdrawal Syndrome

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts

Secondary Outcomes