SmokingNCT01898507
Nicotine Metabolism and Low Nicotine Cigarettes
A study testing Low nicotine cigarettes in people with Smoking, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study examines the effects of smoking low nicotine cigarettes in different groups of smokers. The investigators are focusing on differences in how smokers' bodies break down and eliminate nicotine from their systems. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Low nicotine cigarettes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to 2 Dec 2015
- 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
- adults age 21-65.
- smoking at least 10 cigarettes per day.
- smoking daily for the last 5 years.
- Provide a baseline breath CO reading equal to or greater than 10 parts per million.
- smoke predominantly non-menthol filtered cigarettes (research cigarettes are only non-menthol).
- not currently using any other nicotine containing products such as cigars, smokeless tobacco, nicotine replacement therapies (patch or gum).
- are fluent in English and are capable of providing written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form.
- Participants who meet the inclusion/exclusion criteria and attend an Intake Visit for medical screening will be asked to provide a blood sample to determine NMR. Only those individuals who are characterized as slow or rapid, based on NMRs ≤ .26, or ≥ .42, will be eligible.
Who cannot join
- use of any nicotine containing products other than cigarettes
- current or impending enrollment in smoking cessation program
- history in the last year or current treatment of substance abuse (other than nicotine dependence)
- positive drug screen for cocaine, methamphetamines or opiates for urine drug screen at intake session
- alcohol use greater than 25 standard drinks per week
- current or planned pregnancy or lactating
Show all 18Show fewer
- history or current diagnosis of psychosis, bipolar disorder, mania, or schizophrenia
- current major depression (history of major depression but in remission for a minimum 6 months is eligible).
- serious or unstable disease within past year (e.g. cancer other than melanoma, heart disease)
- history or current diagnosis of COPD
- history of stroke or heart attack
- age less than 21 years- We wish to recruit smokers with well established smoking patterns and will restrict recruitment to those over 21
- age more than 65 years - smoking is often associated with cardiovascular and pulmonary obstructive diseases that manifest later in life. As smokers develop these problems, smoking behavior and biomarkers of harm may be affected therefore we will restrict enrollment to those under age 65
- provide baseline CO reading less than 10 at initial session
- current use (or use within past 14 days) of any medication that affects the biotransformation of nicotine, such as anticonvulsant drugs, rifampin, and disulfiram; or any psychoactive medications which can affect smoking behaviors
- any conditions viewed by the PI or study physician as creating a potential increased risk to a participant due to their participation will be reasons for exclusion
- at the discretion of the PI, any participants viewed as non-compliant will be excluded from further participation
- Smoke cigarettes with a filter size other than standard or slim sized as the topography mouthpieces are sized for standard filters and have an adapter for slim cigarettes only.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
This study examines the effects of smoking low nicotine cigarettes in different groups of smokers. The investigators are focusing on differences in how smokers' bodies break down and eliminate nicotine from their systems. Some people are fast metabolizers of nicotine, meaning they break down and eliminate nicotine from their bodies more quickly. Other people are slower metabolizers meaning they break down and eliminate nicotine more slowly. The investigators are comparing these two groups of smokers for their responses to low nicotine cigarettes. The investigators hypothesize that individuals who smoke low nicotine cigarettes may smoke more intensely or smoke more each day, thereby maintaining their desired nicotine levels, and as a result continue to be exposed to significant toxin levels.
Read the detailed description
This study examines the effects of smoking low nicotine cigarettes on smoking behaviors and toxin exposure in fast and slow nicotine metabolizing smokers. We will recruit current smokers (split between slow and rapid nicotine metabolizing smokers) for a 35-day protocol. Participants will smoke their own brand cigarettes during a baseline 5 day period, followed by a 15-day period of smoking low nicotine content cigarette level 1: 0.25 mg nicotine content, followed by a 15-day period of smoking low nicotine content cigarette level 2: 0.08 mg nicotine content. This application is designed to provide empirical science to inform the FDA on the effect smoking low nicotine content cigarettes will have on use patterns and harm exposure.
- Conditions
- Smoking
- Being tested
- Low nicotine cigarettes
- Keywords
- low nicotine, cigarettes, NMR
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low nicotine cigarettesOther
15-day period of smoking low nicotine content cigarette level 1: 0.25 mg nicotine content, followed by a 15-day period of smoking low nicotine content cigarette level 2: 0.08 mg nicotine content.
| Study group | Role | What they receive |
|---|---|---|
| Low nicotine cigarettes | Experimental | Participants will smoke their own brand cigarettes during a baseline 5 day period, followed by a 15-day period of smoking low nicotine content cigarette level 1: 0.25 mg nicotine content, followed by a 15-day period of smoking low nicotine content cigarette level 2: 0.08 mg nicotine content.
Other: Low nicotine cigarettes Receives: Other: Low nicotine cigarettes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking topography- total puff volume
Measured: up to 35 days
Secondary outcomes (3)
Daily cigarette consumption
Total number of cigarettes smoked each day.
Measured: Study day 0, 5, 10, 15, 20, 25, 30, 35
Urine nicotine metabolite measures
NNK, mercapturic acid metabolites, total nicotine equivalents
Measured: Assessed at Days 5, 20 and 35
Carbon monoxide measurements
Measured: Study day 0, 5, 10, 15, 20, 25, 30, 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startSep 2013
- Primary completionNov 2015
- Study completion2 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Strasser, University of Pennsylvania
- Investigators
- Andrew Strasser, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01898507
- Sponsor's protocol ID
- 816228
- Status last verified
- Jul 2018
- First submitted
- 3 Jul 2013
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotine Metabolism and Low Nicotine Cigarettes
- ClinicalTrials.gov ID
- NCT01898507
- Acronym / sponsor ID
- 816228
- Conditions
- Smoking
- Keywords
- low nicotine, cigarettes, NMR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Sep 2013 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- 2 Dec 2015 (actual)
- First posted
- 12 Jul 2013 (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.
This study examines the effects of smoking low nicotine cigarettes in different groups of smokers. The investigators are focusing on differences in how smokers' bodies break down and eliminate nicotine from their systems. Some people are fast metabolizers of nicotine, meaning they break down and eliminate nicotine from their bodies more quickly. Other people are slower metabolizers meaning they break down and eliminate nicotine more slowly. The investigators are comparing these two groups of smokers for their responses to low nicotine cigarettes. The investigators hypothesize that individuals who smoke low nicotine cigarettes may smoke more intensely or smoke more each day, thereby maintaining their desired nicotine levels, and as a result continue to be exposed to significant toxin levels.
Detailed description
This study examines the effects of smoking low nicotine cigarettes on smoking behaviors and toxin exposure in fast and slow nicotine metabolizing smokers. We will recruit current smokers (split between slow and rapid nicotine metabolizing smokers) for a 35-day protocol. Participants will smoke their own brand cigarettes during a baseline 5 day period, followed by a 15-day period of smoking low nicotine content cigarette level 1: 0.25 mg nicotine content, followed by a 15-day period of smoking low nicotine content cigarette level 2: 0.08 mg nicotine content. This application is designed to provide empirical science to inform the FDA on the effect smoking low nicotine content cigarettes will have on use patterns and harm exposure.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low nicotine cigarettes | Experimental | Other: Low nicotine cigarettesParticipants will smoke their own brand cigarettes during a baseline 5 day period, followed by a 15-day period of smoking low nicotine content cigarette level 1: 0.25 mg nicotine content, followed by a 15-day period of smoking low nicotine content cigarette level 2: 0.08 mg nicotine content. Other: Low nicotine cigarettes |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- adults age 21-65.
- smoking at least 10 cigarettes per day.
- smoking daily for the last 5 years.
- Provide a baseline breath CO reading equal to or greater than 10 parts per million.
- smoke predominantly non-menthol filtered cigarettes (research cigarettes are only non-menthol).
Key exclusion criteria (18 listed)
- use of any nicotine containing products other than cigarettes
- current or impending enrollment in smoking cessation program
- history in the last year or current treatment of substance abuse (other than nicotine dependence)
- positive drug screen for cocaine, methamphetamines or opiates for urine drug screen at intake session
- alcohol use greater than 25 standard drinks per week
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 |
|---|---|---|
| Low nicotine cigarettes15-day period of smoking low nicotine content cigarette level 1: 0.25 mg nicotine content, followed by a 15-day period of smoking low nicotine content cigarette level 2: 0.08 mg nicotine content. | Other | Low nicotine cigarettes |
Primary outcome
Smoking topography- total puff volume
Time frame: up to 35 days
3 secondary outcomes
Daily cigarette consumption
Time frame: Study day 0, 5, 10, 15, 20, 25, 30, 35
Urine nicotine metabolite measures
Time frame: Assessed at Days 5, 20 and 35
Carbon monoxide measurements
Time frame: Study day 0, 5, 10, 15, 20, 25, 30, 35
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 18 Jul 2018.
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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.
Andrew Strasser, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low nicotine cigarettes in people with Smoking, run by University of Pennsylvania 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 18 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 18 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. 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- total puff volume (time frame: up to 35 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 18 Jul 2018.