NCT03102931

Brief Summary

The overall objective of this clinical study is to determine if smokers who switch from their usual high reactive oxygen and nitrous oxide species (ROS/NOS) products to a low ROS/NOS product exhibit increased or decreased levels of oxidative stress/damage, respectively.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 31, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 6, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

July 11, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2018

Completed
Last Updated

March 4, 2019

Status Verified

February 1, 2019

Enrollment Period

8 months

First QC Date

March 31, 2017

Last Update Submit

February 28, 2019

Conditions

NicotineOxidative Stress

Outcome Measures

Primary Outcomes (1)

  • Biomarkers of oxidative stress

    The primary endpoint is to assess whether levels of oxidative stress/damage increase or decrease when a smoker switches from a high ROS/NOS cigarette product to a low ROS/NOS product. The biomarkers that will be used to assess oxidative stress include: 8-0HdG, glutathionylated proteins, and urinary F,-isoprostanes cysteine and GSH.

    8 weeks

Secondary Outcomes (1)

  • Antioxidant and nutrient levels in the blood

    8 weeks

Study Arms (1)

Reduced ROS/RNS content products

EXPERIMENTAL

Participants will be given and asked to smoke research cigarettes for the first 4 weeks. For the final 4 weeks of the study they will be given and asked to smoke low ROS content cigarettes.

Other: Reduced ROS/RNS content productsOther: Typical to high (ROS/NOS) products

Interventions

Reduced ROS/RNS content productsOTHER

Participants will be given and asked to spoke only the cigarettes provided for them. Biosamples and surveys will be collected every 2 weeks throughout the study.

Reduced ROS/RNS content products
Typical to high (ROS/NOS) productsOTHER

Participants will be given and asked to spoke only the cigarettes provided for them. Biosamples and surveys will be collected every 2 weeks throughout the study.

Reduced ROS/RNS content products

Eligibility Criteria

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

You may qualify if:

  • Age 21-65
  • Smoke 10 cigarettes per day or more for at least one year
  • Read and write in English
  • Menthol and nonmenthol smokers
  • Able to understand and provide consent to study procedures
  • Plan to live in the local area for the next 3 months
  • 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 3 months (ensuring stability of smoking)

You may not qualify if:

  • Currently pregnant or nursing
  • Unstable or significant medical conditions that affect oxidative stress, such as COPD, kidney failure, heart disease, stroke, cancer, tumors, lung or respiratory disease, diabetes, liver disease, autoimmune disorder, rheumatoid arthritis, infectious disease or fibromyalgia.
  • Use of non-cigarette nicotine delivery
  • History of difficulties providing blood samples: fainting, poor veins, anxiety, etc.
  • Current or recent history of substance or alcohol abuse
  • No more than seven alcoholic drinks a week, and/ or \>two drinks a day
  • Use of a high dose antioxidant supplement prior to 1 month
  • Currently smoking cigarettes that will be used for the study (Pall Mall Red or American Spirit Dark Green)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Hershey

Hershey, Pennsylvania, 17033, United States

Location

Study Officials

  • John Richie, Ph.D

    Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 31, 2017

First Posted

April 6, 2017

Study Start

July 11, 2017

Primary Completion

March 6, 2018

Study Completion

March 6, 2018

Last Updated

March 4, 2019

Record last verified: 2019-02

Locations

US(1)