Little Cigar Oxidants

N/ANot Yet RecruitingNCT06310187

Milton S. Hershey Medical Center50 enrolled

Overview

Determine the effects of little cigars on human exposure to tobacco smoke oxidants. In a balanced randomized cross-over study design in cigarette smokers, subjects will be assigned to 3 exposure groups. These include a high oxidant little cigar exposure condition, a low oxidant little cigar exposure condition, and their usual cigarette. Biological samples will be collected before and after product usage.

Exhaled breath condensate samples will be collected at pre-product usage, post-product usage, 30, and 60 minutes. Samples will be analyzed for levels of oxidant markers including 8-isoprostanes, 8-OHdG acrolein adducts and C-reactive protein. Exhaled breath samples will be collected at pre-product usage and post-product usage. Samples will be analyzed for levels of oxidant markers in Volitive Organic Compound (VOC) profiles. Blood samples will be collected at pre-product usage and post-product usage. Samples will be analyzed nicotine, 8-isoprostane and other oxidative makers of stress. Buccal cell samples will be collected at pre-product usage and post-product usage. Samples will be analyzed for 8-OHdG adducts. Salvia samples will be collected at pre-product usage and post-product usage. Samples will be analyzed for 8-OHdG adducts and metabolomic profiles.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Tobacco Use Oxidative Stress

Interventions

High Oxidant Little CigarOTHER

Subjects will be given a high oxidant little cigar to use for outcome measure data collection in the lab before and after product usage.

Low Oxidant Little CigarOTHER

Subjects will be given a low oxidant little cigar to use for outcome measure data collection in the lab before and after product usage.

Usual CigaretteOTHER

Subjects will use their own cigarette for outcome measure data collection in the lab before and after product usage.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Aged 21 - 65 years old 2. Daily cigarette smoker (\>= 1 cigarette per day); 3. Smoke regular, filtered cigarettes or machine rolled cigarettes with a filter 4. No current or past use of Little Cigars 5. All other forms of nicotine must be used \<6 days out of the past 30 days. 6. Able to read and write in English 7. No serious cigarette smoking quit attempt or use of any FDA-approved smoking cessation medication in the prior 30 days 8. No plan to quitting smoking in the next 3 months Exclusion Criteria: 1. Women who are pregnant and/or nursing or trying to become pregnant 2. Unstable or significant medical condition in the past 3 months (e.g., recent heart attack or other serious heart condition, stroke, severe angina) 3. Respiratory diseases (e.g., exacerbations of asthma or Chronic Obstructive Pulmonary Disease (COPD), require oxygen, require oral prednisone), kidney (e.g., dialysis) or liver disease (e.g., cirrhosis), severe immune system disorders (e.g., uncontrolled HIV/AIDS, multiple sclerosis symptoms) or any medical disorder/medication that may affect participant safety or biomarker data 4. Uncontrolled substance abuse or inpatient treatment for that condition in the past 6 months 5. Exhaled Carbon Monoxide (CO) measurement of \>= 17 parts per million

Outcomes

Primary Outcomes

8-isoprostanes Concentration in Exhaled Breath Condensate

Time frame: -5 minutes

8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate

Time frame: -5 minutes

C-reactive Protein Concentration in Exhaled Breath Condensate

Time frame: -5 minutes

8-isoprostanes Concentration in Exhaled Breath Condensate

Time frame: 0 minutes

8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate

Time frame: 0 minutes

C-reactive Protein Concentration in Exhaled Breath Condensate

Time frame: 0 minutes

8-isoprostanes Concentration in Exhaled Breath Condensate

Time frame: 30 minutes

8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate

Time frame: 30 minutes

C-reactive Protein Concentration in Exhaled Breath Condensate

Time frame: 30 minutes

8-isoprostanes Concentration in Exhaled Breath Condensate

Time frame: 60 minutes

8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate

Time frame: 60 minutes

C-reactive Protein Concentration in Exhaled Breath Condensate

Central Contacts

Joshua Muscat, Ph.D.

CONTACT

7175318521 jmuscat@pennstatehealth.psu.edu

Kenneth Houser, MS

CONTACT

7175315473 khouser@pennstatehealth.psu.edu

Data from ClinicalTrials.gov

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