Cigarette SmokingNCT01202942
Use and Harm Exposure in New Low Nicotine Cigarettes
A study testing Quest in people with Cigarette Smoking, run by University of Pennsylvania at 1 site in United States.
Trial summary
The proposed research extends previous research on Quest® cigarette smoking behavior by testing whether compensatory smoking occurs as cigarette nicotine level decreases, and whether, as a result, biomarkers of harm exposure increase. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- Quest
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Jun 2013
- 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
- Self-report smoking > 15 daily cigarettes.
- Self-report smoking only non-menthol cigarettes.
- Not currently trying to quit smoking, or planning to quit in the next 2 months.
- Interested in trying a new cigarette-like product.
Who cannot join
- Not meeting any of the inclusion criteria.
- Self-report drinking > 25 alcohol-containing drinks per week.
- Self-report currently using any nicotine replacement products.
- Self-report substance use disorders (abuse or dependence involving alcohol, cocaine, or stimulants, benzodiazepines, not nicotine) in the last 5 years.
- Self-report past history of Axis I psychiatric disorders other than depression
- Self-report myocardial infarct within the past year.
- Females must not be currently pregnant, planning a pregnancy during the study, or currently breastfeeding/lactating.
- Provide a baseline CO reading < 10 ppm
Trial locations and contacts
1 site in 1 country.
United States1 site
Tobacco Use Research Center, UPenn
Philadelphia, Pennsylvania, 19104
About this study
Official title: Smoking Topography and Harm Exposure in a New Potentially Reduced Exposure Product
The proposed research extends previous research on Quest® cigarette smoking behavior by testing whether compensatory smoking occurs as cigarette nicotine level decreases, and whether, as a result, biomarkers of harm exposure increase. This hypothesis will be tested in 210 smokers who report smoking at least 15 cigarettes per day and have been smoking for at least five years and are not currently interested in quitting, but interested in trying a new cigarette product. Participants will be randomized to one of three conditions: 1) smoke their own preferred brand (control group); 2) smoke Quest® cigarettes in progressively decreasing cigarette nicotine level (step-down); or 3) Quest® cigarette non-step-down condition, where they will smoke Quest® cigarettes in a random order. The study will consist of 4 stages beginning with a 5-day preferred own brand cigarette smoking phase for all participants, followed by one of the three cigarette conditions. For those smoking Quest® cigarettes, cigarette nicotine level will change every 10 days, either in a step-down or random fashion. The primary behavioral outcome is smoking topography, a quantitative measurement of smoke exposure. Alveolar carbon monoxide (CO), a validated assessment of smoke exposure, and urine samples to assess carcinogen exposure, specifically NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) and 1-HOP (1-hydroxypyrere), and exhaled breath condensate will also be collected at the laboratory visits. At the initiation of the study, participants will view the Quest® print advertisement and complete a survey related to product expectations in order to determine the impact marketing and advertisement has on beliefs, attitudes and behaviors related to Quest® cigarettes.
- Conditions
- Cigarette Smoking
- Being tested
- Quest
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestOther
Participants smoke Quest cigarettes level 1 for 10 days, level 2 for 10 days, level 3 for 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Quest | Experimental | Participants smoke Quest cigarettes level 1 for 10 days, followed by level 2 for 10 days, and finally by level 3 for 10 days. Receives: Other: Quest |
| Preferred brand | No intervention | Participants smoke their preferred brand of cigarettes for the duration of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking topography measures increase as nicotine levels decrease
Measured: Every five days over 35 day study participation
Secondary outcomes (3)
Nicotine levels effects on smoking topography
Measured: Every 5 days over 35 day study participation.
Whether smokers' inferences from advertising affect smoking behavior
Measured: Every 5 days over 35 day study participation.
Whether carbon monoxide boost and biomarkers of harm increase as cigarette nicotine levels decrease
Measured: Every 5 days over 35 day study participation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study startJul 2007
- Primary completionMay 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cigarette 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01202942
- Sponsor's protocol ID
- 805584
- Status last verified
- Nov 2012
- First submitted
- 14 Sep 2010
- Last updated
- 19 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
DeAtley T, Stone MD, Johnson AC, Mercincavage M, Audrain-McGovern J, Strasser AA. Differences in biobehavioral measures of cigarette smoking by depression symptomology. Addict Behav. 2023 Nov;146:107800. doi: 10.1016/j.addbeh.2023.107800. Epub 2023 Jul 3.
PubMed 37437421
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Topography and Harm Exposure in a New Potentially Reduced Exposure Product
- ClinicalTrials.gov ID
- NCT01202942
- Acronym / sponsor ID
- 805584
- Conditions
- Cigarette Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jul 2007
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 16 Sep 2010 (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 proposed research extends previous research on Quest® cigarette smoking behavior by testing whether compensatory smoking occurs as cigarette nicotine level decreases, and whether, as a result, biomarkers of harm exposure increase. This hypothesis will be tested in 210 smokers who report smoking at least 15 cigarettes per day and have been smoking for at least five years and are not currently interested in quitting, but interested in trying a new cigarette product. Participants will be randomized to one of three conditions: 1) smoke their own preferred brand (control group); 2) smoke Quest® cigarettes in progressively decreasing cigarette nicotine level (step-down); or 3) Quest® cigarette non-step-down condition, where they will smoke Quest® cigarettes in a random order. The study will consist of 4 stages beginning with a 5-day preferred own brand cigarette smoking phase for all participants, followed by one of the three cigarette conditions. For those smoking Quest® cigarettes, cigarette nicotine level will change every 10 days, either in a step-down or random fashion. The primary behavioral outcome is smoking topography, a quantitative measurement of smoke exposure. Alveolar carbon monoxide (CO), a validated assessment of smoke exposure, and urine samples to assess carcinogen exposure, specifically NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) and 1-HOP (1-hydroxypyrere), and exhaled breath condensate will also be collected at the laboratory visits. At the initiation of the study, participants will view the Quest® print advertisement and complete a survey related to product expectations in order to determine the impact marketing and advertisement has on beliefs, attitudes and behaviors related to Quest® cigarettes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quest | Experimental | Other: QuestParticipants smoke Quest cigarettes level 1 for 10 days, followed by level 2 for 10 days, and finally by level 3 for 10 days. |
| Preferred brand | No intervention | –Participants smoke their preferred brand of cigarettes for the duration of the study. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Self-report smoking > 15 daily cigarettes.
- Self-report smoking only non-menthol cigarettes.
- Not currently trying to quit smoking, or planning to quit in the next 2 months.
- Interested in trying a new cigarette-like product.
Key exclusion criteria (8 listed)
- Not meeting any of the inclusion criteria.
- Self-report drinking > 25 alcohol-containing drinks per week.
- Self-report currently using any nicotine replacement products.
- Self-report substance use disorders (abuse or dependence involving alcohol, cocaine, or stimulants, benzodiazepines, not nicotine) in the last 5 years.
- Self-report past history of Axis I psychiatric disorders other than depression
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 |
|---|---|---|
| QuestParticipants smoke Quest cigarettes level 1 for 10 days, level 2 for 10 days, level 3 for 10 days. | Other | Quest |
Primary outcome
Smoking topography measures increase as nicotine levels decrease
Time frame: Every five days over 35 day study participation
3 secondary outcomes
Nicotine levels effects on smoking topography
Time frame: Every 5 days over 35 day study participation.
Whether smokers' inferences from advertising affect smoking behavior
Time frame: Every 5 days over 35 day study participation.
Whether carbon monoxide boost and biomarkers of harm increase as cigarette nicotine levels decrease
Time frame: Every 5 days over 35 day study participation.
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 19 Dec 2013.
- Derived from this study: PubMed 37437421DeAtley T, Stone MD, Johnson AC, Mercincavage M, Audrain-McGovern J, Strasser AA. Differences in biobehavioral measures of cigarette smoking by depression symptomology. Addict Behav. 2023 Nov;146:107800. doi: 10.1016/j.addbeh.2023.107800. Epub 2023 Jul 3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quest in people with Cigarette 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 4 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 19 Dec 2013. 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 measures increase as nicotine levels decrease (time frame: Every five days over 35 day study participation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01202942, which also lists 1 linked publication.
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 19 Dec 2013.