Health TrialsbyHealthPanel

Little Cigar Oxidants

ConditionsTobacco UseOxidative Stress
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-65
SponsorMilton S. Hershey Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • High Oxidant Little Cigar

    Other intervention

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

  • Low Oxidant Little Cigar

    Other intervention

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

  • Usual Cigarette

    Other intervention

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

Treatment groups

50 Participants
are divided into 3 treatment groups
Group A: Group AExperimental treatment 3 interventions
Group B: Group BExperimental treatment 3 interventions
Group C: Group CExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

8-isoprostanes Concentration in Exhaled Breath Condensate

Time frame
-5 minutes
2

8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate

Time frame
-5 minutes
3

C-reactive Protein Concentration in Exhaled Breath Condensate

Time frame
-5 minutes
4

8-isoprostanes Concentration in Exhaled Breath Condensate

Time frame
0 minutes

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Milton S. Hershey Medical Center

Lead sponsor

Penn State University

Sponsor institution

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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