SmokingNCT01898559
Nicotine Metabolism and Little Cigars
A study testing Switch to smoking only little cigars in people with Smoking, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study examines the effects of smoking little cigars 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?
- Switch to smoking only little cigars
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Sep 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
- adults age 21-65.
- smoking at least 10 cigarettes per day.
- smoking daily for the last 5 years.
- Provide a baseline breath CO reading 10 parts per million.
- smoke predominantly filtered cigarettes.
- not currently using any other nicotine containing products such as smokeless tobacco, nicotine
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- 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.
- Have smoked at least 25 cigars in their lifetime
- 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 or opiates for urine drug screen at intake session
- alcohol use greater than 25 standard drinks per week
- current or planned pregnancy or lactating
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- 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- participants must be 21 years old to give consent to volunteer
- 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.
- Participants with a positive breath alcohol reading at intake session where they are being consented may be rescheduled. If participants have a positive breath alcohol at a rescheduled intake session, they will be excluded.
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 little cigars 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 when they switch to smoking cigars instead of cigarettes.
Read the detailed description
This study examines the effects of switching from cigarette to little cigar smoking 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 20-day protocol. Participants will smoke their own brand cigarettes during a baseline 5 day period, followed by 15 days smoking little cigars. This study will use a validated, phenotypic marker of nicotine metabolism rate that may identify those individuals at greatest risk of harm exposure when using little cigars. This study will examine the compensatory effects of little cigars on smoking behaviors and toxin exposure among slow and rapid nicotine metabolizers.
- Conditions
- Smoking
- Being tested
- Switch to smoking only little cigars
- Keywords
- little cigars, cigarettes, smoking
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Switch to smoking only little cigarsOther
Participants smoke only little cigars for 15 days.
| Study group | Role | What they receive |
|---|---|---|
| Black & Mild little cigars | Experimental | Participants switch from smoking their own brand of cigarettes to only smoking Black \& Mild little cigars.
Other: Switch to smoking only little cigars Receives: Other: Switch to smoking only little cigars |
| King Edward little cigars | Experimental | Participants switch from smoking their own brand of cigarettes to only smoking King Edward little cigars.
Other: Switch to smoking only little cigars Receives: Other: Switch to smoking only little cigars |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cigars consumed daily
The number of cigars smoked each day.
Measured: 20 days
Secondary outcomes (2)
Carbon monoxide measurements
Measured: Each study day 0, 5, 10, 15, 20
Nicotine metabolites from urine samples
Measures of NNK, mercapturic acid metabolites, total nicotine equivalents.
Measured: 20 days
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 startDec 2012
- Primary completionOct 2014
- Study completionSep 2017
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Strasser, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01898559
- Sponsor's protocol ID
- 816605
- Status last verified
- Oct 2017
- First submitted
- 3 Jul 2013
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Deidentified data will be made publicly available via a request to study PI within one year of completion of the study.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotine Metabolism and Little Cigars
- ClinicalTrials.gov ID
- NCT01898559
- Acronym / sponsor ID
- 816605
- Conditions
- Smoking
- Keywords
- little cigars, cigarettes, smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Sep 2017 (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 little cigars 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 when they switch to smoking cigars instead of cigarettes.
Detailed description
This study examines the effects of switching from cigarette to little cigar smoking 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 20-day protocol. Participants will smoke their own brand cigarettes during a baseline 5 day period, followed by 15 days smoking little cigars. This study will use a validated, phenotypic marker of nicotine metabolism rate that may identify those individuals at greatest risk of harm exposure when using little cigars. This study will examine the compensatory effects of little cigars on smoking behaviors and toxin exposure among slow and rapid nicotine metabolizers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Black & Mild little cigars | Experimental | Other: Switch to smoking only little cigarsParticipants switch from smoking their own brand of cigarettes to only smoking Black \& Mild little cigars. Other: Switch to smoking only little cigars |
| King Edward little cigars | Experimental | Other: Switch to smoking only little cigarsParticipants switch from smoking their own brand of cigarettes to only smoking King Edward little cigars. Other: Switch to smoking only little cigars |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 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 10 parts per million.
- smoke predominantly filtered cigarettes.
Key exclusion criteria (19 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 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 |
|---|---|---|
| Switch to smoking only little cigarsParticipants smoke only little cigars for 15 days. | Other | Black & Mild little cigars, King Edward little cigars |
Primary outcome
Number of cigars consumed daily
Time frame: 20 days
The number of cigars smoked each day.
2 secondary outcomes
Carbon monoxide measurements
Time frame: Each study day 0, 5, 10, 15, 20
Nicotine metabolites from urine samples
Time frame: 20 days
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 6 Oct 2017.
- Individual participant dataSharing planned: Yes. Deidentified data will be made publicly available via a request to study PI within one year of completion of the study.
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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 Switch to smoking only little cigars 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 10 inclusion and 19 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 6 Oct 2017. 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?
Number of cigars consumed daily (time frame: 20 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 6 Oct 2017.