Little Cigar Oxidants

Oxidative Stress Clinical Trial

Official title:

Oxidative Stress and Harmful Constituent Levels Associated With Little Cigars

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06310187
• Other study ID #: STUDY00023967
• Secondary ID: U54DA058271-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: August 2029

Study information

• Verified date: March 2024
• Source: Milton S. Hershey Medical Center
• Contact: Joshua Muscat, Ph.D.
• Phone: 7175318521
• Email: jmuscat[@]pennstatehealth.psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: August 2029
• Est. primary completion date: August 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Oxidative Stress
• Tobacco Use

Intervention

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)
• 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)
• 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)
• 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)
• Usual Cigarette - Group E
Subjects will use one of their own cigarettes in the collection of outcome measure data in the lab.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	National Institute on Drug Abuse (NIDA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hydrogen Peroxide Concentration in Exhaled Breath Condensate		0 minutes
Primary	Hydrogen Peroxide Concentration in Exhaled Breath Condensate		30 minutes
Primary	Hydrogen Peroxide Concentration in Exhaled Breath Condensate		60 minutes
Primary	Hydrogen Peroxide Concentration in Exhaled Breath Condensate		120 minutes
Primary	8-isoprostanes Concentration in Exhaled Breath Condensate		0 minutes
Primary	8-isoprostanes Concentration in Exhaled Breath Condensate		30 minutes
Primary	8-isoprostanes Concentration in Exhaled Breath Condensate		60 minutes
Primary	8-isoprostanes Concentration in Exhaled Breath Condensate		120 minutes
Primary	C-reactive Protein Concentration in Exhaled Breath Condensate		0 minutes
Primary	C-reactive Protein Concentration in Exhaled Breath Condensate		30 minutes
Primary	C-reactive Protein Concentration in Exhaled Breath Condensate		60 minutes
Primary	C-reactive Protein Concentration in Exhaled Breath Condensate		120 minutes
Primary	Nicotine Concentration in Exhaled Breath Condensate		0 minutes
Primary	Nicotine Concentration in Exhaled Breath Condensate		30 minutes
Primary	Nicotine Concentration in Exhaled Breath Condensate		60 minutes
Primary	Nicotine Concentration in Exhaled Breath Condensate		120 minutes
Primary	4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone [NNK] Concentration in Exhaled Breath Condensate		0 minutes
Primary	4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone [NNK] Concentration in Exhaled Breath Condensate		30 minutes
Primary	4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone [NNK] Concentration in Exhaled Breath Condensate		60 minutes
Primary	4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone [NNK] Concentration in Exhaled Breath Condensate		120 minutes
Primary	N'-nitrosonornicotine [NNN] Concentration in Exhaled Breath Condensate		0 minutes
Primary	N'-nitrosonornicotine [NNN] Concentration in Exhaled Breath Condensate		30 minutes
Primary	N'-nitrosonornicotine [NNN] Concentration in Exhaled Breath Condensate		60 minutes
Primary	N'-nitrosonornicotine [NNN] Concentration in Exhaled Breath Condensate		120 minutes