Little Cigar Oxidants

Oxidative Stress and Harmful Constituent Levels Associated With Little Cigars

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.

Study Overview

• Status: Recruiting
• Conditions: Tobacco Use; Oxidative Stress
• Intervention / Treatment: Other: High Oxidant Little Cigar; Other: Low Oxidant Little Cigar; Other: Usual Cigarette

Detailed Description

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
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kenneth Houser, MS; Phone Number: 7175315473; Email: khouser@pennstatehealth.psu.edu
• Study Contact Backup: Name: Joshua Muscat, Ph.D.; Phone Number: 7175318521; Email: jmuscat@pennstatehealth.psu.edu

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Recruiting
      • Penn State College of Medicine
      • Contact: Kenneth Houser, MS; Phone Number: 7175315473; Email: khouser@pennstatehealth.psu.edu
      • Principal Investigator: Joshua Muscat, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Subjects will be given the high oxidant little cigar for their first laboratory visit. They will then be given the low oxidant little cigar for the second visit followed by using their own cigarette at the final laboratory visit.	Other: High Oxidant Little Cigar; Subjects will be given a high oxidant little cigar to use for outcome measure data collection in the lab before and after product usage.; Other: Low Oxidant Little Cigar; Subjects will be given a low oxidant little cigar to use for outcome measure data collection in the lab before and after product usage.; Other: Usual Cigarette; Subjects will use their own cigarette for outcome measure data collection in the lab before and after product usage.
Experimental: Group B; Subjects will be given the low oxidant little cigar for their first laboratory visit. They will then use their own cigarette for the second visit followed by being given the high oxidant little cigar at the final laboratory visit.	Other: High Oxidant Little Cigar; Subjects will be given a high oxidant little cigar to use for outcome measure data collection in the lab before and after product usage.; Other: Low Oxidant Little Cigar; Subjects will be given a low oxidant little cigar to use for outcome measure data collection in the lab before and after product usage.; Other: Usual Cigarette; Subjects will use their own cigarette for outcome measure data collection in the lab before and after product usage.
Experimental: Group C; Subjects will use their own cigarette for their first laboratory visit. They will then be given the high oxidant little cigar for the second visit followed by being given the low oxidant little cigar at the final laboratory visit.	Other: High Oxidant Little Cigar; Subjects will be given a high oxidant little cigar to use for outcome measure data collection in the lab before and after product usage.; Other: Low Oxidant Little Cigar; Subjects will be given a low oxidant little cigar to use for outcome measure data collection in the lab before and after product usage.; Other: Usual Cigarette; Subjects will use their own cigarette for outcome measure data collection in the lab before and after product usage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
8-isoprostanes Concentration in Exhaled Breath Condensate	0 minutes
8-isoprostanes Concentration in Exhaled Breath Condensate	30 minutes
8-isoprostanes Concentration in Exhaled Breath Condensate	60 minutes
C-reactive Protein Concentration in Exhaled Breath Condensate	0 minutes
C-reactive Protein Concentration in Exhaled Breath Condensate	30 minutes
C-reactive Protein Concentration in Exhaled Breath Condensate	60 minutes
8-isoprostanes Concentration in Exhaled Breath Condensate	-5 minutes
8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate	-5 minutes
C-reactive Protein Concentration in Exhaled Breath Condensate	-5 minutes
8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate	0 minutes
8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate	30 minutes
8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate	60 minutes
Oxidant makers in Volitive Organic Compound Profiles in Exhaled Breath Samples	-5 minutes
Oxidant makers in Volitive Organic Compound Profiles in Exhaled Breath Samples	0 minutes
Nicotine concentration in Blood Samples	-5 minutes
Nicotine concentration in Blood Samples	0 minutes
8-isoprostanes Concentration in Blood Samples	-5 minutes
8-isoprostanes Concentration in Blood Samples	0 minutes
8-OHdg Acrolein Adduct Concentration in Buccal Cell Samples	-5 minutes
8-OHdg Acrolein Adduct Concentration in Buccal Cell Samples	0 minutes
8-OHdg Acrolein Adduct Concentration in Saliva Samples	-5 minutes
8-OHdg Acrolein Adduct Concentration in Saliva Samples	0 minutes
Metabolomic Profiles in Saliva Samples	-5 minutes
Metabolomic Profiles in Saliva Samples	0 minutes

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Joshua Muscat, Ph.D., Penn State Hershey College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029

Study Registration Dates

• First Submitted: March 7, 2024
• First Submitted That Met QC Criteria: March 7, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Tobacco Use
• Other Study ID Numbers: STUDY000023967; U54DA058271-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No