NCT06310187

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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
38mo left

Started Mar 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Mar 2026Aug 2029

First Submitted

Initial submission to the registry

March 7, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
2 years until next milestone

Study Start

First participant enrolled

March 23, 2026

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2029

Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

3.4 years

First QC Date

March 7, 2024

Last Update Submit

April 7, 2026

Conditions

Tobacco UseOxidative Stress

Outcome Measures

Primary Outcomes (24)

  • 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-isoprostanes Concentration in Exhaled Breath Condensate

    0 minutes

  • 8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate

    0 minutes

  • C-reactive Protein Concentration in Exhaled Breath Condensate

    0 minutes

  • 8-isoprostanes Concentration in Exhaled Breath Condensate

    30 minutes

  • 8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate

    30 minutes

  • C-reactive Protein Concentration in Exhaled Breath Condensate

    30 minutes

  • 8-isoprostanes Concentration in Exhaled Breath Condensate

    60 minutes

  • 8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate

    60 minutes

  • C-reactive Protein 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

Study Arms (3)

Group A

EXPERIMENTAL

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 CigarOther: Low Oxidant Little CigarOther: Usual Cigarette

Group B

EXPERIMENTAL

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 CigarOther: Low Oxidant Little CigarOther: Usual Cigarette

Group C

EXPERIMENTAL

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 CigarOther: Low Oxidant Little CigarOther: Usual Cigarette

Interventions

High Oxidant Little CigarOTHER

Subjects will be given a high oxidant little cigar to use for outcome measure data collection in the lab before and after product usage.

Group AGroup BGroup C
Low Oxidant Little CigarOTHER

Subjects will be given a low oxidant little cigar to use for outcome measure data collection in the lab before and after product usage.

Group AGroup BGroup C
Usual CigaretteOTHER

Subjects will use their own cigarette for outcome measure data collection in the lab before and after product usage.

Group AGroup BGroup C

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 21 - 65 years old
  • Daily cigarette smoker (\>= 1 cigarette per day);
  • Smoke regular, filtered cigarettes or machine rolled cigarettes with a filter
  • No current or past use of Little Cigars
  • All other forms of nicotine must be used \<6 days out of the past 30 days.
  • Able to read and write in English
  • No serious cigarette smoking quit attempt or use of any FDA-approved smoking cessation medication in the prior 30 days
  • No plan to quitting smoking in the next 3 months

You may not qualify if:

  • Women who are pregnant and/or nursing or trying to become pregnant
  • Unstable or significant medical condition in the past 3 months (e.g., recent heart attack or other serious heart condition, stroke, severe angina)
  • 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
  • Uncontrolled substance abuse or inpatient treatment for that condition in the past 6 months
  • Exhaled Carbon Monoxide (CO) measurement of \>= 17 parts per million

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

RECRUITING

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Joshua Muscat, Ph.D.

    Penn State Hershey College of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joshua Muscat, Ph.D.

CONTACT

7175318521jmuscat@pennstatehealth.psu.edu

Kenneth Houser, MS

CONTACT

7175315473khouser@pennstatehealth.psu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Williams Design for Cross over-trials with a 3-period 3-treatment cross-over design in 36 healthy daily cigarette smokers.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Public Health Sciences

Study Record Dates

First Submitted

March 7, 2024

First Posted

March 15, 2024

Study Start

March 23, 2026

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

August 1, 2029

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)