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New treatment option for Smoking (Tobacco) Addiction
Official title Addiction Potential of Very Low Nicotine Filtered Little Cigars
ClinicalTrials.gov ID: NCT06630728
What this study is testing
What is Reduced Nicotine Content Cigars?
Reduced Nicotine Content Cigars is an investigational medicine, being studied as a potential treatment for smoking (tobacco) addiction.
Also referred to as VLNFLC.
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 clinical trial is to learn how reducing the nicotine content in filtered little cigars can affect the the use of these cigars and lung health in current adult filtered little cigar users. The main question(s) it aims to answer are: Are puffing behaviors, appeal/satisfaction, craving suppression, pharmacokinetic effects, and demand similar between the regular cigars smoked by participants, normal nicotine study cigars and very low nicotine study cigars?
- Phase 4: studies an already-approved treatment
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 75. Healthy volunteers may be eligible.
You may be able to join if
- Smokers: 1) self-reported regular current filtered little cigars, cigarillos, little cigars, or small cigars use for the past 3 months; regular use...
- willing to abstain from all tobacco and nicotine for at least 12 hours prior to lab sessions
- Willing to bring their own, preferred brand little cigars/ small cigars/ cigarillos/ filtered little cigars to smoke in the lab on the first study...
- capable of and willing to provide written informed consent
- read and speak in English.
You likely can't join if
- Self-reported significant current lung disease (e.g. asthma, COPD, cystic fibrosis, pulmonary fibrosis); exercise-induced asthma, seasonal allergies...
- History of diagnosis or treatment for lung cancer
- Self-reported serious or uncontrolled kidney disease, liver disease, metabolic disease (thyroid, diabetes)
- History of cardiac event or distress within the past 3 months
- Unstable or significant psychiatric conditions (past and stable conditions will be allowed)
- Substance use disorders besides nicotine addiction
See the full eligibility criteria
- Smokers: 1) self-reported regular current filtered little cigars, cigarillos, little cigars, or small cigars use for the past 3 months; regular use will be defined as \>=8 cigars smoked per month based on data showing...
- willing to abstain from all tobacco and nicotine for at least 12 hours prior to lab sessions
- Willing to bring their own, preferred brand little cigars/ small cigars/ cigarillos/ filtered little cigars to smoke in the lab on the first study visit
- capable of and willing to provide written informed consent
- read and speak in English.
- Self-reported significant current lung disease (e.g. asthma, COPD, cystic fibrosis, pulmonary fibrosis); exercise-induced asthma, seasonal allergies for which a patient takes inhalers are allowed
- History of diagnosis or treatment for lung cancer
- Self-reported serious or uncontrolled kidney disease, liver disease, metabolic disease (thyroid, diabetes)
- History of cardiac event or distress within the past 3 months
- Unstable or significant psychiatric conditions (past and stable conditions will be allowed)
- Substance use disorders besides nicotine addiction
- Regular use of other tobacco products besides cigarettes such as snuff, chewing tobacco, snus, e-cigarettes \>10d per month
- Exclusive large or premium cigar users
- Use of blunts every time or most of the time
- Regular use of cannabis \>10d per month
- Planning to quit in next 30 days or currently trying to quit or quit attempt in past 30 days
- Pregnant, delivery in past 12 weeks, breastfeeding, or planning to get pregnant
- Inability to perform tests or follow instructions during testing
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, 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.