Evaluation of the Electronic Cigarette Withdrawal Syndrome

July 14, 2026 updated by: Johns Hopkins University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Recruiting
        • Behavioral Pharmacology Research Unit
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transdermal Nicotine Patch
Participants assigned to this condition will receive a blinded nicotine patch and will wear the patch on their upper arm, per the manufacturer's instructions.
Drug: Transdermal Nicotine Patch
Blinded Nicotine Patch
Placebo Comparator: Transdermal Placebo Patch
Participants assigned to this placebo nicotine patch condition will receive a blinded patch containing 0mg of nicotine, and will wear the patch on their upper arm, per the manufacturer's instructions.
Drug: Placebo Nicotine Patch
Blinded Patch with No Nicotine
No Intervention: No Patch
Participants assigned to this condition will not receive a patch.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, every 4 hours up to 16 hours
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.
Baseline, every 4 hours up to 16 hours
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.
Baseline, every 4 hours up to 16 hours
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.
Baseline, every 4 hours up to 16 hours
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.
Baseline, every 4 hours up to 16 hours
Total sleep time
Time Frame: Nightly up to seven days
Total time sleeping in minutes measured using actigraphy and unobtrusive EEG.
Nightly up to seven days
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.
Nightly up to seven days
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.
Nightly up to seven days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, every 4 hours up to 16 hours
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.
Baseline, every 4 hours up to 16 hours
Return to Use
Time Frame: Day 14
Return to e-cigarette use at the one week follow-up.
Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Justin Strickland, Ph.D., Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2023

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

September 28, 2023

First Submitted That Met QC Criteria

September 28, 2023

First Posted (Actual)

October 4, 2023

Study Record Updates

Last Update Posted (Actual)

July 15, 2026

Last Update Submitted That Met QC Criteria

July 14, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00407275
  • R01DA057925 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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