Recruiting
Early Phase 1

Electronic Cigarette

Sponsor:

Johns Hopkins University

Code:

NCT06066996

Conditions

E-cigarette Use

Withdrawal

Eligibility Criteria

Sex: All

Age: 21 - 55

Healthy Volunteers: Accepted

Interventions

Transdermal Nicotine Patch

Placebo Nicotine Patch

Study Details

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.

Conditions

E-cigarette Use

Withdrawal

Study ID

NCT06066996

Start date

Nov 28, 2023

Status verified date

Jul, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 55

Healthy Volunteers: Accepted

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 Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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.

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.

no intervention: No Patch

Participants assigned to this condition will not receive a patch.

Interventions

Transdermal Nicotine Patch

Blinded Nicotine Patch

Placebo Nicotine Patch

Blinded Patch with No Nicotine

Primary outcome measure

  • Change in Hughes-Hatsukami Withdrawal Scale [ 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 [ Time Frame: 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 ]
  • Change in Conners' Continuous Performance Task (CPT) [ Time Frame: 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 ]
  • Total sleep time [ Time Frame: Nightly up to seven days ]
  • Total time spent in Rapid eye movement (REM) sleep [ Time Frame: Nightly up to seven days ]
  • Wake after sleep onset (WASO) [ Time Frame: Nightly up to seven days ]

Central Contacts and Locations

Central contacts

Justin Strickland, Ph.D.

4105501975jstric14@jhmi.edu

Locations

Behavioral Pharmacology Research Unit

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Justin Strickland, Ph.D.

410-550-1975jstric14@jhmi.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Jul 15, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-07-15.