Tobacco Smoking BehaviorNCT02415270
Switching to Reduced Oxidant or Nicotine Content Cigarettes in Smokers
A study testing Reduced Nicotine Cigarettes and Reduced ROS/RNS in people with Tobacco Smoking Behavior, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Smoking Behavior
- What is being tested?
- Reduced Nicotine Cigarettes and Reduced ROS/RNS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 1 Jan 2017
- 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/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
Who cannot join
- 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.
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Switching to Reduced Nicotine Content Cigarettes or Reduced Reactive Oxygen/Reactive Nitrogen Species Cigarettes in Smokers
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.
Read the detailed description
Researchers at Penn State Hershey are seeking healthy adult cigarette smokers between 21-65 who smoke any of the following brands on a regular basis: Marlboro Red, Marlboro Menthol, Pall Mall Red, Pall Mall Menthol, Kool Menthol, Salem Menthol, L\&M Menthol, Pyramid Red, Newport Red, Newport Menthol.
If you smoke one of these brand styles on a regular basis you may be eligible to participate in a compensated short term study on health and smoking behavior at Penn State Hershey Medical Center.
Study participation lasts 22 days, with 4 study visits at the Medical Center. Smokers are asked to use their usual brand for one week and then switch to 1 of 3 brands for the remaining two weeks. The three brands participants are randomly assigned to after the first week of participation are either Group 1. reduced nicotine content cigarette (Spectrum Research Cigarettes) or Group 2. reduced oxidant cigarette (American Spirit) or assigned to Group 3. usual brand. Whichever group you are assigned to, you will be asked to smoke only these until the end of the study. All cigarettes following visit 1 will be provided free of charge.
Study overview:
Visit 1/ Duration: 60 minutes Provide a blood and urine sample Complete a 20 minute interview Use a simple, hand held smoking device to smoke all cigarettes for 2 days Collect cigarette butts on 1 day
Visit 2: Randomized Phase /Duration: 20-30 minutes Provide a blood and urine sample Complete a 10 minute interview Use a simple, hand held smoking device to smoke all cigarettes for 2 days Collect cigarette butts on 1 day
Visit 3/ Duration: 20-30 minutes Provide a blood and urine sample Complete a 10 minute interview Use a simple, hand held smoking device to smoke all cigarettes for 2 days Collect cigarette butts on 1 day
Visit 4/ Duration: 20-30 minutes Provide a blood and urine sample Complete a 10 minute interview Sign compensation form
For information on additional tobacco studies being conducted at Penn State Hershey, please call 1-844-207-6392
*This research is being conducted under the investigator John Richie at Penn State Hershey; 500 University Drive Hershey, PA
- Conditions
- Tobacco Smoking Behavior
- Being tested
- Reduced Nicotine Cigarettes, Reduced ROS/RNS, Control
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced Nicotine CigarettesOther
Also called Cigarette contains .28mg (.29mg/menthol) of nicotine
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
Reduced ROS/RNSOther
Also called Cigarette to be determined by lab experiment
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
ControlOther
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
| Study group | Role | What they receive |
|---|---|---|
| Reduced Nicotine Cigarettes | Experimental | Participants will be randomized to receive low nicotine cigarettes to replace their usual high nicotine brand. Receives: 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. Receives: Other: Reduced ROS/RNS |
| Control Group | Placebo comparator | Participants will be assigned to continue smoking their usual brand of cigarettes. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Topography
measures of smoking topography include parameters such as puff volume, frequency and intensity as measured using a smoking topography instrument.
Measured: 8 days
Secondary outcomes (1)
Biomarkers of oxidative stress
biomarkers of oxidative stress are as followed: glutathionylated and cysteinylated proteins in blood and F2-isoprostanes and 8-hydroxydeoxyguanosine (8-OHdG).
Measured: 4 times over the 22 day study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study startJan 2016
- Primary completionJan 2017
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Smoking BehaviorStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 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
- NCT02415270
- Sponsor's protocol ID
- STUDY00001996
- Other IDs
- 5P50DA036107-02
- Status last verified
- Jul 2018
- First submitted
- 9 Apr 2015
- Last updated
- 27 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Switching to Reduced Nicotine Content Cigarettes or Reduced Reactive Oxygen/Reactive Nitrogen Species Cigarettes in Smokers
- ClinicalTrials.gov ID
- NCT02415270
- Acronym / sponsor ID
- STUDY00001996
- Conditions
- Tobacco Smoking Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 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
- Jan 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 14 Apr 2015 (estimated)
- 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 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.
Detailed description
Researchers at Penn State Hershey are seeking healthy adult cigarette smokers between 21-65 who smoke any of the following brands on a regular basis: Marlboro Red, Marlboro Menthol, Pall Mall Red, Pall Mall Menthol, Kool Menthol, Salem Menthol, L\&M Menthol, Pyramid Red, Newport Red, Newport Menthol.
If you smoke one of these brand styles on a regular basis you may be eligible to participate in a compensated short term study on health and smoking behavior at Penn State Hershey Medical Center.
Study participation lasts 22 days, with 4 study visits at the Medical Center. Smokers are asked to use their usual brand for one week and then switch to 1 of 3 brands for the remaining two weeks. The three brands participants are randomly assigned to after the first week of participation are either Group 1. reduced nicotine content cigarette (Spectrum Research Cigarettes) or Group 2. reduced oxidant cigarette (American Spirit) or assigned to Group 3. usual brand. Whichever group you are assigned to, you will be asked to smoke only these until the end of the study. All cigarettes following visit 1 will be provided free of charge.
Study overview:
Visit 1/ Duration: 60 minutes Provide a blood and urine sample Complete a 20 minute interview Use a simple, hand held smoking device to smoke all cigarettes for 2 days Collect cigarette butts on 1 day
Visit 2: Randomized Phase /Duration: 20-30 minutes Provide a blood and urine sample Complete a 10 minute interview Use a simple, hand held smoking device to smoke all cigarettes for 2 days Collect cigarette butts on 1 day
Visit 3/ Duration: 20-30 minutes Provide a blood and urine sample Complete a 10 minute interview Use a simple, hand held smoking device to smoke all cigarettes for 2 days Collect cigarette butts on 1 day
Visit 4/ Duration: 20-30 minutes Provide a blood and urine sample Complete a 10 minute interview Sign compensation form
For information on additional tobacco studies being conducted at Penn State Hershey, please call 1-844-207-6392
*This research is being conducted under the investigator John Richie at Penn State Hershey; 500 University Drive Hershey, PA
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reduced Nicotine Cigarettes | Experimental | Other: Reduced Nicotine CigarettesParticipants will be randomized to receive low nicotine cigarettes to replace their usual high nicotine brand. |
| Reduced ROS/RNS | Experimental | Other: Reduced ROS/RNSParticipants will be randomized to receive Reduced Oxidative/Nitrogen Species (ROS/RNS) cigarettes to replace their usual cigarettes. |
| Control Group | Placebo comparator | Other: ControlParticipants will be assigned to continue smoking their usual brand of 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/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
Key exclusion criteria (9 listed)
- 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
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 Nicotine CigarettesAlso: Cigarette contains .28mg (.29mg/menthol) of nicotineHuman 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 | Other | Reduced Nicotine Cigarettes |
| Reduced ROS/RNSAlso: Cigarette to be determined by lab experimentHuman 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 | Other | Reduced ROS/RNS |
| ControlHuman 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 | Other | Control Group |
Primary outcome
Smoking Topography
Time frame: 8 days
measures of smoking topography include parameters such as puff volume, frequency and intensity as measured using a smoking topography instrument.
1 secondary outcome
Biomarkers of oxidative stress
Time frame: 4 times over the 22 day study period
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 27 Jul 2018.
- 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 Nicotine Cigarettes and Reduced ROS/RNS in people with Tobacco Smoking Behavior, 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 9 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 27 Jul 2018. 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. Some participants in this study may receive a placebo. 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?
Smoking Topography (time frame: 8 days). 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 27 Jul 2018.