NCT06066996

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for early_phase_1

Timeline
26mo left

Started Nov 2023

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Nov 2023Jun 2028

First Submitted

Initial submission to the registry

September 28, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 4, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

November 28, 2023

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

July 14, 2025

Status Verified

July 1, 2025

Enrollment Period

4.6 years

First QC Date

September 28, 2023

Last Update Submit

July 9, 2025

Conditions

E-cigarette UseWithdrawal

Outcome Measures

Primary Outcomes (8)

  • 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.

    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.

    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.

    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.

    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.

    Baseline, every 4 hours up to 16 hours

  • Total sleep time

    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

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

    Nightly up to seven days

  • Wake after sleep onset (WASO)

    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 Outcomes (3)

  • Change in E-Cigarette Demand Intensity

    Baseline, every 4 hours up to 16 hours

  • Change in E-Cigarette Demand Elasticity

    Baseline, every 4 hours up to 16 hours

  • Return to Use

    Day 14

Study Arms (3)

Transdermal Nicotine Patch

EXPERIMENTAL

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

Transdermal Placebo Patch

PLACEBO COMPARATOR

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

No Patch

NO INTERVENTION

Participants assigned to this condition will not receive a patch.

Interventions

Transdermal Nicotine PatchDRUG

Blinded Nicotine Patch

Transdermal Nicotine Patch
Placebo Nicotine PatchDRUG

Blinded Patch with No Nicotine

Transdermal Placebo Patch

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

RECRUITING

MeSH Terms

Conditions

Vaping

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

SmokingBehavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Justin Strickland, Ph.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Justin Strickland, Ph.D.

CONTACT

4105501975jstric14@jhmi.edu

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2023

First Posted

October 4, 2023

Study Start

November 28, 2023

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

July 14, 2025

Record last verified: 2025-07

Locations

US(1)