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Official title The Role of Flavor in the Substitutability of E-cigarettes for Combustible Cigarettes Among Persistent Smokers
ClinicalTrials.gov ID: NCT06264154
What this study is testing
- What it's testing
- This between-subjects study aims to evaluate the effect of flavor on initial and sustained switching from combustible cigarettes to e-cigarettes among 210 cigarette smokers. After measuring baseline cigarette smoking rate, participants will be randomized to a six-week regimen of fruit-flavored, tobacco-flavored, or menthol-flavored e-cigarettes and be instructed to switch (versus smoking cigarettes) over a 6-week period.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older. Healthy volunteers may be eligible.
You may be able to join if
- Able to communicate fluently in English (i.e. speaking, writing, and reading)
- Male and female smokers who are \> 21 years of age and self-report smoking at least 5 cigarettes (menthol and/or non-menthol) per day for at least...
- 5 or more failed quit attempts and the use of smoking cessation medication on at least one prior attempt.
- Ever use of an e-cigarette
- Have a carbon monoxide (CO) greater than 10 ppm
You likely can't join if
- Smoking Behavior Regular use of nicotine-containing products other than cigarettes (e.g., chewing tobacco, snuff, snus, cigars, e-cigs, etc.)...
- Participants agreeing to abstain from using nicotine-containing products other than cigarettes for the duration of the study will be considered...
- Current enrollment or plans to enroll in a smoking cessation program over the duration of the study.
- Current use of smoking cessation medication
- Provide a CO breath test reading less than 10 ppm at Intake. Alcohol and Drug
- History of substance abuse (other than nicotine dependence) in the past 12 months.
See the full eligibility criteria
- Able to communicate fluently in English (i.e. speaking, writing, and reading)
- Male and female smokers who are \> 21 years of age and self-report smoking at least 5 cigarettes (menthol and/or non-menthol) per day for at least the last 12 months
- 5 or more failed quit attempts and the use of smoking cessation medication on at least one prior attempt.
- Ever use of an e-cigarette
- Have a carbon monoxide (CO) greater than 10 ppm
- Not using any forms of nicotine regularly other than cigarettes
- Be willing to switch to e-cigarettes for 6 weeks and use the assigned flavors
- Plan to live in the area for the duration of the study
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form.
- Smoking Behavior Regular use of nicotine-containing products other than cigarettes (e.g., chewing tobacco, snuff, snus, cigars, e-cigs, etc.). Regular e-cigarette use is defined as greater than 5 days/past 30 days
- Participants agreeing to abstain from using nicotine-containing products other than cigarettes for the duration of the study will be considered eligible.
- Current enrollment or plans to enroll in a smoking cessation program over the duration of the study.
- Current use of smoking cessation medication
- Provide a CO breath test reading less than 10 ppm at Intake. Alcohol and Drug
- History of substance abuse (other than nicotine dependence) in the past 12 months.
- Current alcohol consumption that exceeds 20 standard drinks/week.
- Current use of recreational drugs (other than nicotine and cannabis)
- Breath alcohol reading (BrAC) greater than .000 at Intake. Medical
- Women, including all individuals assigned as "female" at birth, who are pregnant, breastfeeding, or planning a pregnancy over the duration of the study period.
- Serious or unstable disease within the past year (e.g. cancer, heart disease). Applicable conditions will be evaluated on a case-by-case basis by the Principal Investigator.
- Allergies to either propylene glycol or flavor additives Psychiatric 1\. Lifetime history of schizophrenia or psychosis. General Exclusion
- Past, current, anticipated, or pending enrollment in another research program over the study period that could potentially impact subject safety, study data, and/or the study design as determined by the Principal...
- Any medical condition, illness, disorder, adverse event (AE), or concomitant medication that could compromise participant safety or significantly impact study performance as determined by the Principal Investigator...
- Significant non-compliance with protocol and/or study design as determined by the Principal Investigator and/o. people may be deemed ineligible at any point throughout the study.
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, 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 and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, 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.