Switching to Reduced Oxidant or Nicotine Content Cigarettes in Smokers

NCT02415270 | Completed DMC

• 2 other identifiers: STUDY000019965P50DA036107-02
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tobacco Smoking Behavior

Outcome Measures

Primary Outcomes (1)

• Smoking Topography

  measures of smoking topography include parameters such as puff volume, frequency and intensity as measured using a smoking topography instrument.

  8 days

Secondary Outcomes (1)

• Biomarkers of oxidative stress

  4 times over the 22 day study period

Study Arms (3)

Reduced Nicotine Cigarettes

EXPERIMENTAL

Participants will be randomized to receive low nicotine cigarettes to replace their usual high nicotine brand.

Other: Reduced Nicotine Cigarettes

Reduced ROS/RNS

EXPERIMENTAL

Participants will be randomized to receive Reduced Oxidative/Nitrogen Species (ROS/RNS) cigarettes to replace their usual cigarettes.

Other: Reduced ROS/RNS

Control Group

PLACEBO COMPARATOR

Participants will be assigned to continue smoking their usual brand of cigarettes.

Other: Control

Interventions

Reduced Nicotine Cigarettes OTHER

Human topography data will show if smokers smoke their cigarettes differently from baseline following randomization. Select biosamples of participants will be used to analyze how biomarkers differ among groups

Also known as: Cigarette contains .28mg (.29mg/menthol) of nicotine

Reduced Nicotine Cigarettes

Reduced ROS/RNS OTHER

Human topography data will show if smokers smoke their cigarettes differently from baseline following randomization. Select biosamples of participants will be used to analyze how biomarkers differ among groups

Also known as: Cigarette to be determined by lab experiment

Reduced ROS/RNS

Control OTHER

Human topography data will show if smokers change the way they smoke due to being in a research study. Select biosamples of participants will be used to analyze how biomarkers differ among groups

Control Group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21-65
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• Food and Drug Administration (FDA): collaborator
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Penn State Hershey

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Smoking

Interventions

Menthol; Nicotine

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Cyclohexane Monoterpenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Monoterpenes; Terpenes; Lipids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• John Richie, Ph.D

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 9, 2015
• First Posted: April 14, 2015
• Study Start: January 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: July 27, 2018

Record last verified: 2018-07

Locations

US (1)