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NCT Number: NCT06066996

Evaluation of the Electronic Cigarette Withdrawal Syndrome

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.

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Key information

Conditions

E-cigarette Use Behavior Smoking Vaping Withdrawal

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

Location status: Recruiting

Location contact

Justin Strickland, Ph.D.

CONTACT

[email protected]

410-550-1975

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 21-55 years old
  • good general health as reviewed by study medical team
  • vital signs in normal range as reviewed by study medical team
  • negative urine test for illicit drug use (excluding THC) and negative breath alcohol test
  • daily use of a nicotine-containing e-cigarette for at least 6 months
  • no regular use of other tobacco products (e.g., smokeless products) for at least 6 months
  • urine cotinine >100ng/mL (i.e., recommended cutoff for confirming current nicotine use)
  • exhaled breath carbon monoxide (CO) <6ppm
  • Penn State E-cigarette Dependence (PSED) score >=4, indicating mild dependence or greater
  • have an interest in reducing e-cigarette use

Exclusion criteria

  • psychoactive drug use (aside from cannabis, nicotine, alcohol, caffeine) in past month
  • current use of over-the-counter (OTC) or prescription medications that may impact safety
  • use cannabis >2 times per week
  • history of or current significant medical condition that would impact participation or safety according to the study investigators and medical staff
  • 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
  • enrollment in another trial
  • positive pregnancy test
  • currently using a nicotine/tobacco cessation product
  • seizure disorder or traumatic brain injury (TBI)

Treatment and study plan

Transdermal Nicotine Patch

Drug

Blinded Nicotine Patch

Placebo nicotine patch

Drug

Blinded Patch with No Nicotine

Primary outcomes

  1. Change in Hughes-Hatsukami Withdrawal Scale

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

    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.

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

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

    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.

  3. Change in Positive and Negative Affect Schedule (PANAS)

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

    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.

  4. Change in Conners' Continuous Performance Task (CPT)

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

    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.

  5. Change in Memory as assessed by the N-Back

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

    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.

  6. Total sleep time

    Time frame: Nightly up to seven days

    Total time sleeping in minutes measured using actigraphy and unobtrusive EEG.

  7. Total time spent in Rapid eye movement (REM) sleep

    Time frame: Nightly up to seven days

    Total time sleeping in minutes in REM stage measured using actigraphy and unobtrusive EEG.

  8. Wake after sleep onset (WASO)

    Time frame: Nightly up to seven days

    Total number of minutes that a person is awake after having initially fallen asleep measured using actigraphy and unobtrusive EEG.

Secondary outcomes

  1. Change in E-Cigarette Demand Intensity

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

    E-cigarette use at unconstrained price measured using a commodity purchase task. Higher scores reflect more demand (worse outcome). Measures are taken at baseline, 8am, 12pm, 4pm, and 8pm every day during the seven day residential stay.

  2. Change in E-Cigarette Demand Elasticity

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

    Sensitivity of e-cigarette use to price measured using a commodity purchase task. Higher scores reflect more price sensitivity (better outcome). Measures are taken at baseline, 8am, 12pm, 4pm, and 8pm every day during the seven day residential stay.

  3. Return to Use

    Time frame: Day 14

    Return to e-cigarette use at the one week follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

Justin Strickland, Ph.D.

CONTACT

[email protected]

4105501975

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Oct 4, 2023
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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