Switching to Reduced Oxidant or Nicotine Content Cigarettes in Smokers

• Status: Recruiting
• Trial end date: 0000-00-00
• Target enrollment: 70
• Participant gender: Both

Summary

The overall objectives of this clinical study are to determine in smokers the short term effects of switching to tobacco products that deliver low levels of nicotine or reactive oxygen/nitrogen species (ROS/RNS) on smoking behavior and biomarkers of tobacco smoke exposure and oxidative stress.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Milton S. Hershey Medical Center
• Collaborators: Food and Drug Administration (FDA); National Institute on Drug Abuse (NIDA); National Institutes of Health (NIH)
• Treatments: Nicotine
• Last Updated: 2016-06-28

Criteria

Inclusion Criteria:

• Age 21-55

• Smoke 10 cigarettes/day or more for at least one year

• Read and write in English

• Menthol and nonmenthol smokers who use relatively high nicotine and ROS/RNS cigarettes

• Able to understand and provide consent to study procedures

• Plan to live in the local area for the next month

• Women not pregnant or nursing and taking steps to avoid pregnancy

• No quit attempt in the last one months and not planning to quit in the next month

Exclusion Criteria:

• Currently pregnant or nursing

• Unstable or significant medical condition, such as COPD or kidney failure, that is likely to affect biomarker data

• Use of non-cigarette nicotine delivery product in the past week (included cigars, pipes, chew, snus, hookah, e-cig, and marijuana)

• Currently reducing or planning to reduce cigarette consumption in the next month

• Use of smoking cessation medicine in the past 3 months

• History of difficulties providing blood samples: fainting, poor veins, anxiety, etc.

• Uncontrolled serious psychotic illness or substance abuse or inpatient treatment for these in the last 6 months (substance abuse includes weekly, almost daily or daily use of other illegal drugs and prescription drugs that are not being used for medically prescribed purposes or alcohol abuse that would hinder the participant's ability to participate)

• Significant medical condition, i.e. stroke, MI, cancer, in the last month

• Currently using illegal drugs