Clinical trial NCT06630728: Addiction Potential of Very Low Nicotine Filtered Little Cigars
Official title: Addiction Potential of Very Low Nicotine Filtered Little Cigars
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Smoking (Tobacco) Addiction
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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? Are health effects and toxicant exposure similar between the regular cigars smoked by participants, normal nicotine study cigars and very low nicotine study cigars?

Participants will attend three study visits at OSU. Each visit would last up to 4 hours. During visits, they will

* fill several surveys
* provide blood samples
* perform breathing tests
* complete smoking sessions using either their own cigars or the study cigars.


Eligibility criteria: Inclusion 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 median cigarillo use is 7.5 times per month and median FLC use is 14 times per month 59. We will attempt to bring in heavier users if feasible during recruitment; or 2) Dual-users: cigarette smokers (\>=20d/month for at least 3 months) with co-use of filtered little cigars, cigarillos, little cigars, or small cigars (at least once in the past 3 months)
* 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.

Exclusion Criteria:

* 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
* Zero use of filtered little cigars, cigarillos, little cigars, or small cigars in the past 3 months
* 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

Primary outcomes:
measure: Drug self-administration- Puff topography- total puff volume
timeFrame: During session 65 minute puffing session
measure: Forced expiratory volume in 1 second
timeFrame: Change from 0 to 65 minutes
measure: Nicotine
timeFrame: Change from 0 to 5 minutes
measure: Nicotine
timeFrame: Change from 0 to 65 minutes
measure: Carbon monoxide boost
timeFrame: Change from 0 to 5 minutes
measure: Carbon monoxide boost
timeFrame: Change from 0 to 65 minutes
Secondary outcomes:
measure: Functional residual capacity
timeFrame: Change from 0 to 65 minutes
measure: Airway resistance (R5)
timeFrame: Change from 0 to 65 minutes
measure: Airway resistance (R5-R20)
timeFrame: Change from 0 to 65 minutes
measure: Modified Cigarette Evaluation Scale
timeFrame: 65 minutes
measure: Questionnaire on Smoking Urges (Tiffany Drobes)
timeFrame: Change from 0 to 5 minutes
measure: Questionnaire on Smoking Urges (Tiffany Drobes)
timeFrame: Change from 0 to 65 minutes
measure: Minnesota Nicotine Withdrawal Scale
timeFrame: Change from 0 to 5 minutes
measure: Minnesota Nicotine Withdrawal Scale
timeFrame: Change from 0 to 65 minutes
measure: Hypothetical purchase task
timeFrame: 65 minutes
measure: Cross-price task
timeFrame: 65 minutes
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Dharini M Bhammar, PhD, MBBS
role: PRINCIPAL_INVESTIGATOR
References: