NicotineNCT03102931
Switching to Low Oxidant Content Cigarettes in Adult Smokers
A study testing Reduced ROS/RNS content products and Typical to high (ROS/NOS) products in people with Nicotine and Oxidative Stress, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine, Oxidative Stress
- What is being tested?
- Reduced ROS/RNS content products and Typical to high (ROS/NOS) products
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2017to 6 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Researchers at Penn State Hershey are seeking healthy adult cigarette smokers between the ages of 21-65 who smoke at least 10 cigarettes a day for at least one year.
The aim of this study is to evaluate the effect of reduced oxidative/ nitrogen species (ROS/RNS) cigarettes compared to high ROS/RNS cigarettes.
Study participation lasts 8 weeks, with 5 study visits at the Hershey Medical Center. All eligible participants will be given Spectrum research cigarettes, provided free of charge, and will be asked to only smoke those cigarettes for the first four weeks of the study. Following that four-week period of time all participants will be given low ROS content cigarettes (American Spirit Dark Green or Pall Mall Red). Participants will be asked to smoke only these cigarettes for the final four weeks of the study, these cigarettes will also be provided to you free of charge.
- Conditions
- Nicotine, Oxidative Stress
- Being tested
- Reduced ROS/RNS content products, Typical to high (ROS/NOS) products
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Reduced ROS/RNS content products; Other: Typical to high (ROS/NOS) products |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (1)
Antioxidant and nutrient levels in the blood
Secondary endpoints include measurements of nicotine exposure (urine or plasma cotinine).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start11 Jul 2017
- Primary completion6 Mar 2018
- Study completion6 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NicotineStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Drug Administration (FDA), National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, John P. Richie, Milton S. Hershey Medical Center
- Investigators
- John Richie, Ph.D, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102931
- Sponsor's protocol ID
- STUDY00006759
- Other IDs
- 5P50DA036107-02
- Status last verified
- Feb 2019
- First submitted
- 31 Mar 2017
- Last updated
- 4 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this time we have no plan for sharing, however if need should arise, then sharing may be a possibility.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Switching to Low Oxidant Content Cigarettes in Adult Smokers
- ClinicalTrials.gov ID
- NCT03102931
- Acronym / sponsor ID
- STUDY00006759
- Conditions
- Nicotine, Oxidative Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- Food and Drug Administration (FDA), National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Study start
- 11 Jul 2017 (actual)
- Primary completion
- 6 Mar 2018 (actual)
- Study completion
- 6 Mar 2018 (actual)
- First posted
- 6 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Researchers at Penn State Hershey are seeking healthy adult cigarette smokers between the ages of 21-65 who smoke at least 10 cigarettes a day for at least one year.
The aim of this study is to evaluate the effect of reduced oxidative/ nitrogen species (ROS/RNS) cigarettes compared to high ROS/RNS cigarettes.
Study participation lasts 8 weeks, with 5 study visits at the Hershey Medical Center. All eligible participants will be given Spectrum research cigarettes, provided free of charge, and will be asked to only smoke those cigarettes for the first four weeks of the study. Following that four-week period of time all participants will be given low ROS content cigarettes (American Spirit Dark Green or Pall Mall Red). Participants will be asked to smoke only these cigarettes for the final four weeks of the study, these cigarettes will also be provided to you free of charge.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reduced ROS/RNS content products | Experimental | Other: Reduced ROS/RNS content products, Other: Typical to high (ROS/NOS) productsParticipants 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reduced ROS/RNS content productsParticipants 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. | Other | Reduced ROS/RNS content products |
| Typical to high (ROS/NOS) productsParticipants 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. | Other | Reduced ROS/RNS content products |
Primary outcome
Biomarkers of oxidative stress
Time frame: 8 weeks
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.
1 secondary outcome
Antioxidant and nutrient levels in the blood
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2019.
- Individual participant dataSharing planned: Undecided. At this time we have no plan for sharing, however if need should arise, then sharing may be a possibility.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Richie, Ph.D principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduced ROS/RNS content products and Typical to high (ROS/NOS) products in people with Nicotine and Oxidative Stress, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers of oxidative stress (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2019.