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Behavioral Intervention

Reduced Nicotine Cigars for Smoking Addiction (LOWFLC Trial)

N/A

Waitlist Available

Led By Dharini M Bhammar, PhD, MBBS

Research Sponsored by Ohio State University Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

21-55 years old in age

Be between 18 and 65 years old

Must not have

Regular use of other tobacco products besides cigarettes such as snuff, chewing tobacco, snus, e-cigarettes ≥10d per month

History of diagnosis or treatment for lung cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 65 minutes

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to study how reducing the nicotine content in filtered little cigars can impact the use of these cigars and lung health in adult users. Participants will attend three visits where they will fill surveys, provide

Who is the study for?

This trial is for adult smokers who regularly use filtered little cigars. Participants must be willing to attend three study visits at OSU, which include surveys, blood samples, breathing tests, and smoking sessions with different types of cigars.

What is being tested?

The trial is testing the effects of reducing nicotine in little cigars on users' behavior and lung health. It compares regular user-preferred cigars with normal nicotine content study cigars and very low nicotine content study cigars over three visits.

What are the potential side effects?

Specific side effects are not listed; however, as this trial involves tobacco products, potential risks may include those commonly associated with smoking such as respiratory issues and increased addiction potential.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 21 and 55 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I use tobacco products other than cigarettes regularly.

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I have been diagnosed or treated for lung cancer.

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My BMI is either below 18.5 or above 50.

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I do not have serious or uncontrolled kidney, liver, or metabolic diseases.

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I have not had a heart attack or severe heart issue in the last 3 months.

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I cannot perform tests or follow instructions during testing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 65 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~65 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 65 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Carbon monoxide boost

Drug self-administration- Puff topography- total puff volume

Forced expiratory volume in 1 second

+1 more

Secondary study objectives

Airway resistance (R5)

Airway resistance (R5-R20)

Cross-price task

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Smoking sessionExperimental Treatment3 Interventions

All participants will undergo three smoking sessions: one using their own usual brand cigar, one with a normal nicotine study cigar, and one with a reduced nicotine study cigar

0 / 7Eligibility criteria met