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 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).

Study Overview

• Status: Not yet recruiting
• Conditions: Tobacco Use; Oxidative Stress
• Intervention / Treatment: Other: High Oxidant Unflavored Little Cigar - Group A; Other: Low Oxidant Unflavored Little Cigar - Group B; Other: High Oxidant Flavored Little Cigar - Group C; Other: Low Oxidant Flavored Little Cigar - Group D; Other: Usual Cigarette - Group E; Other: Unlit Little Cigar - Group F

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joshua Muscat, Ph.D.; Phone Number: 7175318521; Email: jmuscat@pennstatehealth.psu.edu

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. 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 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

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Oxidant Unflavored Little Cigar - Group A	Other: High Oxidant Unflavored Little Cigar - Group A; Subjects will be provided with high oxidant unflavored little cigars (One to take home and use ad lib and upon return to the lab, subjects will be given an additional high oxidant unflavored little cigar to use for outcome measure data collection in the lab)
Experimental: Low Oxidant Unflavored Little Cigar - Group B	Other: Low Oxidant Unflavored Little Cigar - Group B; Subjects will be provided with low oxidant unflavored little cigars (One to take home and use ad lib and upon return to the lab, subjects will be given an additional low oxidant unflavored little cigar to use for outcome measure data collection in the lab)
Experimental: High Oxidant Flavored Little Cigar - Group C	Other: High Oxidant Flavored Little Cigar - Group C; Subjects will be provided with high oxidant flavored little cigars (One to take home and use ad lib and upon return to the lab, subjects will be given an additional high oxidant flavored little cigar to use for outcome measure data collection in the lab)
Experimental: Low Oxidant Flavored Little Cigar - Group D	Other: Low Oxidant Flavored Little Cigar - Group D; Subjects will be provided with low oxidant flavored little cigars (One to take home and use ad lib and upon return to the lab, subjects will be given an additional low oxidant flavored little cigar to use for outcome measure data collection in the lab)
Other: Usual Cigarette - Group E; Control Condition - this is the subject's normal cigarette/cigar	Other: Usual Cigarette - Group E; Subjects will use one of their own cigarettes in the collection of outcome measure data in the lab.
Sham Comparator: Unlit Little Cigar - Group F	Other: Unlit Little Cigar - Group F; Subjects will be provided with an unlit little cigars to use for outcome measure data collection in the lab. This will be the control group for outcome measure data.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hydrogen Peroxide Concentration in Exhaled Breath Condensate	0 minutes
Hydrogen Peroxide Concentration in Exhaled Breath Condensate	30 minutes
Hydrogen Peroxide Concentration in Exhaled Breath Condensate	60 minutes
Hydrogen Peroxide Concentration in Exhaled Breath Condensate	120 minutes
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
8-isoprostanes Concentration in Exhaled Breath Condensate	120 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
C-reactive Protein Concentration in Exhaled Breath Condensate	120 minutes
Nicotine Concentration in Exhaled Breath Condensate	0 minutes
Nicotine Concentration in Exhaled Breath Condensate	30 minutes
Nicotine Concentration in Exhaled Breath Condensate	60 minutes
Nicotine Concentration in Exhaled Breath Condensate	120 minutes
4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone [NNK] Concentration in Exhaled Breath Condensate	0 minutes
4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone [NNK] Concentration in Exhaled Breath Condensate	30 minutes
4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone [NNK] Concentration in Exhaled Breath Condensate	60 minutes
4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone [NNK] Concentration in Exhaled Breath Condensate	120 minutes
N'-nitrosonornicotine [NNN] Concentration in Exhaled Breath Condensate	0 minutes
N'-nitrosonornicotine [NNN] Concentration in Exhaled Breath Condensate	30 minutes
N'-nitrosonornicotine [NNN] Concentration in Exhaled Breath Condensate	60 minutes
N'-nitrosonornicotine [NNN] Concentration in Exhaled Breath Condensate	120 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 (Estimated): July 1, 2024
• 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): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00023967; 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