SmokingNCT01568905
Palatability of Experimental Cigarettes - Study 2
A study testing Low level nicotine cigarette, Intermediate nicotine level cigarette and High level nicotine cigarette in people with Smoking, run by University of Minnesota at 1 site in United States.
Trial summary
Smoking remains a leading cause of preventable disease and premature death worldwide. Approximately 1 out of every 5 deaths is associated with cigarette smoking, and roughly half of all daily smokers will die prematurely from tobacco-related illness. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Low level nicotine cigarette, Intermediate nicotine level cigarette and High level nicotine cigarette
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Mar 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-64 years old
- Regular smokers (10+ cigarettes per day and has done so for the last year)
- Inhaling when smoking
- Carbon monoxide (CO) > 8 ppm
Who cannot join
- In the past year, suffered from any cardiovascular disease such as: heart disease, heart attack, stroke or angina, any respiratory diseases such as chronic bronchitis or chronic obstructive pulmonary disease (COPD), any type of cancer
- Currently suffering from Bipolar Disorder, General Anxiety Disorder, Schizophrenia, or a major depressive episode
- Taken any of the following drugs more than twice per week during the past month: antidepressants, anti-anxiety medications.
- Consumed more than 15 alcoholic drinks per week for the past month
- Pregnant, trying to become pregnant, or lactating (assessed by self-report)
- In the past 3 months, used nicotine replacement products (like the patch, gum, or inhaler), or the medications bupropion varenicline
- Currently trying or planning to reduce or quit tobacco use in the next 30 days
- Used other forms of tobacco 10 or more days in the past 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55414
About this study
Official title: Palatability of Experimental Cigarettes
Smoking remains a leading cause of preventable disease and premature death worldwide. Approximately 1 out of every 5 deaths is associated with cigarette smoking, and roughly half of all daily smokers will die prematurely from tobacco-related illness. Reducing the nicotine in cigarettes to the point that they are rendered non-addictive can potentially be an effective public policy measure that can significantly reduce tobacco-related mortality and morbidity by decreasing the initiation of smoking and promoting cessation. The Family Smoking Prevention and Tobacco Control Act (FSPTCA) enables the FDA to establish tobacco product standards including placing limits on the allowable nicotine content of cigarettes. Currently, no reduced nicotine cigarettes are available that will allow studying the feasibility of this policy measure. The National Institute on Drug Abuse has contracted with Research Triangle Institute to assist in the development of cigarettes with varying nicotine content that can be made available to researchers. They have established a contract that will result in the manufacture of 9 million cigarettes to be distributed to the research community. Prior to full production, the palatability and nicotine intake of these cigarettes in smokers must be determined.
Read the detailed description
Phase 3: This descriptive study will use a between subjects, double blind design. This study will test 3 nicotine levels of nicotine, tar and ventilation. Subjects and research assistants will be blind to the cigarette type.
- Conditions
- Smoking
- Being tested
- Low level nicotine cigarette, Intermediate nicotine level cigarette, High level nicotine cigarette
- Keywords
- smoker, smoking, nicotine levels, tobacco, nicotine
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low level nicotine cigaretteOther
smoke the study cigarette exclusively for one week
Intermediate nicotine level cigaretteOther
smoke the study cigarette exclusively for one week
High level nicotine cigaretteOther
smoke the study cigarette exclusively for one week
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 Low Level Nicotine Cigarette | Experimental | (0.4 mg/g) Receives: Other: Low level nicotine cigarette |
| Arm 2 Intermediate Nicotine Level Cigarette | Experimental | (5.7-5.8 mg/g) Receives: Other: Intermediate nicotine level cigarette |
| Arm 3 High Level Nicotine Cigarette | Experimental | (11.4-12.8 mg/g) Receives: Other: High level nicotine cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in UrineTotal Nicotine Equivalent (TNE) Between Baseline and Week 1
Two urine TNE levels are taken, one at baseline and one at week 1, to assess TNE levels for nicotine exposure. TNE is the sum of nicotine, cotinine, trans 3'-hydroxycotinine and their respective glucuronide conjugates. Values reported in nmols/ml.
Measured: Second Visit (Week 1) minus Baseline (Day 1)
Secondary outcomes (3)
Responses on Modified Cigarette Evaluation Scale
Modified Cigarette Evaluation Scale [CES] is a 100 mm visual analog scale (0=not at all or very little nicotine; 100=extremely or high in nicotine) of 20 questions assessing different dimensions of responses to usual brand cigarettes (e.g., psychological reward, satisfaction and aversiveness) and includes additional 5 point likert-type questions (definitely agree to definitely disagree) on perceptions of satisfaction and willingness to use the product. Results satisfaction subscale.
Measured: Baseline usual brand cigarettes (Day 1) compared to when using study cigarettes (Week 1)
Change From Baseline of Perceived Health Risk Scale Response to Test Cigarettes
Questionnaire: Perceived Health Risk Scale asks subjects to rate their perception of health risks for lung cancer for the study product to which they have been randomly assigned. This is a 100 mm visual analog scale; 0=very low risk of disease, 100=very high risk of disease.
Measured: Baseline (Day 1) Compared to Second Visit (Week 1)
Comparison of Number of Cigarettes Smoked
Subjects were given a daily diary to collect the number of study and/or conventional cigarettes they have smoked each day. Cigarettes smoked (both usual brand and experimental) in a given week were summed over the first 7 reported days. If the number of cigarettes smoked was missing for 1 day, the average of the other days in that week was used in its place and reported as total number of cigarettes per week.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study startFeb 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dorothy Hatsukami, Ph.D., Principal investigator, Tobacco Use Research Program, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01568905
- Sponsor's protocol ID
- 1012M94314
- Status last verified
- Oct 2019
- First submitted
- 3 Jan 2012
- Last updated
- 1 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hatsukami DK, Heishman SJ, Vogel RI, Denlinger RL, Roper-Batker AN, Mackowick KM, Jensen J, Murphy SE, Thomas BF, Donny E. Dose-response effects of spectrum research cigarettes. Nicotine Tob Res. 2013 Jun;15(6):1113-21. doi: 10.1093/ntr/nts247. Epub 2012 Nov 22.
PubMed 23178320
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palatability of Experimental Cigarettes
- ClinicalTrials.gov ID
- NCT01568905
- Acronym / sponsor ID
- 1012M94314
- Conditions
- Smoking
- Keywords
- smoker, smoking, nicotine levels, tobacco, nicotine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 2 Apr 2012 (estimated)
- Results
- Posted 12 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Smoking remains a leading cause of preventable disease and premature death worldwide. Approximately 1 out of every 5 deaths is associated with cigarette smoking, and roughly half of all daily smokers will die prematurely from tobacco-related illness. Reducing the nicotine in cigarettes to the point that they are rendered non-addictive can potentially be an effective public policy measure that can significantly reduce tobacco-related mortality and morbidity by decreasing the initiation of smoking and promoting cessation. The Family Smoking Prevention and Tobacco Control Act (FSPTCA) enables the FDA to establish tobacco product standards including placing limits on the allowable nicotine content of cigarettes. Currently, no reduced nicotine cigarettes are available that will allow studying the feasibility of this policy measure. The National Institute on Drug Abuse has contracted with Research Triangle Institute to assist in the development of cigarettes with varying nicotine content that can be made available to researchers. They have established a contract that will result in the manufacture of 9 million cigarettes to be distributed to the research community. Prior to full production, the palatability and nicotine intake of these cigarettes in smokers must be determined.
Detailed description
Phase 3: This descriptive study will use a between subjects, double blind design. This study will test 3 nicotine levels of nicotine, tar and ventilation. Subjects and research assistants will be blind to the cigarette type.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Low Level Nicotine Cigarette | Experimental | Other: Low level nicotine cigarette(0.4 mg/g) |
| Arm 2 Intermediate Nicotine Level Cigarette | Experimental | Other: Intermediate nicotine level cigarette(5.7-5.8 mg/g) |
| Arm 3 High Level Nicotine Cigarette | Experimental | Other: High level nicotine cigarette(11.4-12.8 mg/g) |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-64 years old
- Regular smokers (10+ cigarettes per day and has done so for the last year)
- Inhaling when smoking
- Carbon monoxide (CO) > 8 ppm
Key exclusion criteria (8 listed)
- In the past year, suffered from any cardiovascular disease such as: heart disease, heart attack, stroke or angina, any respiratory diseases such as chronic bronchitis or chronic obstructive pulmonary disease (COPD), any type of cancer
- Currently suffering from Bipolar Disorder, General Anxiety Disorder, Schizophrenia, or a major depressive episode
- Taken any of the following drugs more than twice per week during the past month: antidepressants, anti-anxiety medications.
- Consumed more than 15 alcoholic drinks per week for the past month
- Pregnant, trying to become pregnant, or lactating (assessed by self-report)
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 level nicotine cigarettesmoke the study cigarette exclusively for one week | Other | Arm 1 Low Level Nicotine Cigarette |
| Intermediate nicotine level cigarettesmoke the study cigarette exclusively for one week | Other | Arm 2 Intermediate Nicotine Level Cigarette |
| High level nicotine cigarettesmoke the study cigarette exclusively for one week | Other | Arm 3 High Level Nicotine Cigarette |
Primary outcome
Change in UrineTotal Nicotine Equivalent (TNE) Between Baseline and Week 1
Time frame: Second Visit (Week 1) minus Baseline (Day 1)
Two urine TNE levels are taken, one at baseline and one at week 1, to assess TNE levels for nicotine exposure. TNE is the sum of nicotine, cotinine, trans 3'-hydroxycotinine and their respective glucuronide conjugates. Values reported in nmols/ml.
3 secondary outcomes
Responses on Modified Cigarette Evaluation Scale
Time frame: Baseline usual brand cigarettes (Day 1) compared to when using study cigarettes (Week 1)
Change From Baseline of Perceived Health Risk Scale Response to Test Cigarettes
Time frame: Baseline (Day 1) Compared to Second Visit (Week 1)
Comparison of Number of Cigarettes Smoked
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23178320Hatsukami DK, Heishman SJ, Vogel RI, Denlinger RL, Roper-Batker AN, Mackowick KM, Jensen J, Murphy SE, Thomas BF, Donny E. Dose-response effects of spectrum research cigarettes. Nicotine Tob Res. 2013 Jun;15(6):1113-21. doi: 10.1093/ntr/nts247. Epub 2012 Nov 22.
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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.
Dorothy Hatsukami, Ph.D. principal investigator
Tobacco Use Research Program, University of Minnesota
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 level nicotine cigarette, Intermediate nicotine level cigarette and High level nicotine cigarette in people with Smoking, run by University of Minnesota 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 1 Nov 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?
Yes. Results are posted in the registry (first posted 12 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in UrineTotal Nicotine Equivalent (TNE) Between Baseline and Week 1 (time frame: Second Visit (Week 1) minus Baseline (Day 1)). 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 NCT01568905, 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 1 Nov 2019.