Little Cigar Oxidants

Penn State Health

Status: Not yet enrolling

Conditions: Oxidative Stress; Tobacco Use

Treatments: Other: Usual Cigarette; Other: Low Oxidant Little Cigar; Other: High Oxidant Little Cigar

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06310187

STUDY000023967

U54DA058271-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

Group A

Experimental group

Description:

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.

Treatment:

Other: High Oxidant Little Cigar

Other: Low Oxidant Little Cigar

Other: Usual Cigarette

Group B

Experimental group

Description:

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.

Treatment:

Other: High Oxidant Little Cigar

Other: Low Oxidant Little Cigar

Other: Usual Cigarette

Group C

Experimental group

Description:

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.

Treatment:

Other: High Oxidant Little Cigar

Other: Low Oxidant Little Cigar

Other: Usual Cigarette