BridgeMD
New treatment option for E-cigarette Use
Official title Evaluation of the Electronic Cigarette Withdrawal Syndrome
ClinicalTrials.gov ID: NCT06066996
What this study is testing
What is Transdermal Nicotine Patch?
Transdermal Nicotine Patch is an investigational medicine, being studied as a potential treatment for e-cigarette use.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 55. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join 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...
- enrollment in another trial
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.