Evaluation of the Electronic Cigarette Withdrawal Syndrome

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT06066996
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • E-cigarette Use
  • Withdrawal

Eligibility Criteria

Sex
ALL
Age
21 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Transdermal Nicotine Patch — DRUG
    Blinded Nicotine Patch
  • Placebo Nicotine Patch — DRUG
    Blinded Patch with No Nicotine

Study Details

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.

Key Dates

Start date
Nov 28, 2023
Status verified
Jul 2025
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

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.

Primary Outcome Measure

Change in Hughes-Hatsukami Withdrawal Scale [ Time Frame: Baseline, every 4 hours up to 16 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Behavioral Pharmacology Research UnitBaltimoreMaryland21224
Justin Strickland, Ph.D.
[email protected]
410-550-1975

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By research site
Behavioral Pharmacology Research Unit· Baltimore, MD

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