Little Cigar Oxidants

Not Applicable

Not yet recruiting

• Conditions: Oxidative Stress; Tobacco Use
• Interventions: Other: High Oxidant Flavored Little Cigar - Group C; Other: Low Oxidant Unflavored Little Cigar - Group B; Other: Low Oxidant Flavored Little Cigar - Group D; Other: Usual Cigarette - Group E; Other: Unlit Little Cigar - Group F; Other: High Oxidant Unflavored Little Cigar - Group A

• Registration Number: NCT06310187
• Lead Sponsor: Milton S. Hershey Medical Center

Brief Summary

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 6 exposure groups. These include a high oxidant unflavored little cigar exposure condition, a low oxidant unflavored little cigar exposure condition, a high oxidant flavored exposure condition, a low oxidant flavored exposure little cigar exposure condition, their usual cigarette, and a control condition (unlit little cigar). Following the smoking of each product, exhaled breath condensate samples will be collected at baseline, 30, 60, 90, 120 and 150 minutes. Samples will be analyzed for levels of oxidant markers including hydrogen peroxide, 8-isoprostanes, and C-reactive protein, as well as nicotine, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) and N'-nitrosonornicotine (NNN).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-07
• Study First Submitted QC: 2024-03-07
• Study First Posted: 2024-03-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29
• Study Start: 2025-09
• Primary Completion: 2029-08
• Study Completion: 2029-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Aged 21 and older
2. Daily cigarette smoker (>= 1 cigarette per day);
3. Smoke regular, filtered cigarettes or machine rolled cigarettes with a filter
4. Able to read and write in English
5. No serious cigarette smoking quit attempt or use of any FDA-approved smoking cessation medication in the prior 30 days
6. No plan on quitting smoking in the next 3 months
7. Exhaled Carbon Monoxide (CO) measurement of <= 16 parts per million at baseline
8. Pulmonary Function of 80%-120% determined via Spirometry

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High Oxidant Flavored Little Cigar - Group C	High Oxidant Flavored Little Cigar - Group C	-
Low Oxidant Unflavored Little Cigar - Group B	Low Oxidant Unflavored Little Cigar - Group B	-
Low Oxidant Flavored Little Cigar - Group D	Low Oxidant Flavored Little Cigar - Group D	-
Usual Cigarette - Group E	Usual Cigarette - Group E	Control Condition - this is the subject's normal cigarette/cigar
Unlit Little Cigar - Group F	Unlit Little Cigar - Group F	-
High Oxidant Unflavored Little Cigar - Group A	High Oxidant Unflavored Little Cigar - Group A	-

Primary Outcome Measures

Name	Time	Method
4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone [NNK] Concentration in Exhaled Breath Condensate	120 minutes
8-isoprostanes Concentration in Exhaled Breath Condensate	120 minutes
Hydrogen Peroxide Concentration in Exhaled Breath Condensate	120 minutes
C-reactive Protein Concentration in Exhaled Breath Condensate	120 minutes
Nicotine Concentration in Exhaled Breath Condensate	120 minutes
N'-nitrosonornicotine [NNN] Concentration in Exhaled Breath Condensate	120 minutes