Clinical trial NCT06066996: Evaluation of the Electronic Cigarette Withdrawal Syndrome
Official title: Evaluation of the Electronic Cigarette Withdrawal Syndrome: Mechanistic Targets for Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: E-cigarette Use
Withdrawal
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-10-04
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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 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.

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)

Primary outcomes:
measure: Change in Hughes-Hatsukami Withdrawal Scale
timeFrame: Baseline, every 4 hours up to 16 hours
measure: Change in Smoking urges as assessed by the Tiffany-Drobes Questionnaire of Smoking Urges (QSU) Brief
timeFrame: Baseline, every 4 hours up to 16 hours
measure: Change in Positive and Negative Affect Schedule (PANAS)
timeFrame: Baseline, every 4 hours up to 16 hours
measure: Change in Conners' Continuous Performance Task (CPT)
timeFrame: Baseline, every 4 hours up to 16 hours
measure: Change in Memory as assessed by the N-Back
timeFrame: Baseline, every 4 hours up to 16 hours
measure: Total sleep time
timeFrame: Nightly up to seven days
measure: Total time spent in Rapid eye movement (REM) sleep
timeFrame: Nightly up to seven days
measure: Wake after sleep onset (WASO)
timeFrame: Nightly up to seven days
Secondary outcomes:
measure: Change in E-Cigarette Demand Intensity
timeFrame: Baseline, every 4 hours up to 16 hours
measure: Change in E-Cigarette Demand Elasticity
timeFrame: Baseline, every 4 hours up to 16 hours
measure: Return to Use
timeFrame: Day 14
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Behavioral Pharmacology Research Unit
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Justin Strickland, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: