Nicotine DependenceNCT00264342
Effectiveness of Using Reduced Nicotine Cigarettes in Men and Women Smokers to Combat Nicotine Addiction
An observational study of Nicotine Dependence and Tobacco Use Disorder, run by University of California, San Francisco at 1 site in United States.
Trial summary
This is a 2-year study involving the progressive reduction in the nicotine content of cigarettes. The investigators believe that at the end of the study smokers of cigarettes with progressively reduced nicotine content will be "weaned" from nicotine. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence, Tobacco Use Disorder
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Jul 2010
- Phase
- Observational
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Health adults 18 and over
Who may be able to join
- Healthy on the basis of medical history and screening blood tests
- Current moderate-to-heavy smoker as determined by:
- smoking more than 10 cigarettes per day regularly for the past year (by history); and
- expired carbon monoxide (CO) at screening visit of 25 ppm or more and/or plasma cotinine level of 100 ng/ml or more.
- Age 18-70 years
- Any racial/ethnic background
Who cannot join
- Expressed desire to quit smoking within 6 months.
- Significant medical conditions (such as anemia, heart disease, uncontrolled hypertension, thyroid disease, diabetes, renal or liver impairment, glaucoma, or prostatic hypertrophy) or psychiatric condition (such as current major depression, history of schizophrenia or bipolar disorder, or current regular use of psychiatric medications such as major tranquilizers and antidepressants). Smokers with uncomplicated controlled hypertension may be enrolled.
- Pregnancy or lactation (by history)
- Current use of smokeless tobacco, pipes or cigars
- Alcohol abuse or illicit drug use (by history)
- Concurrent participation in another clinical trial or prior participation in our pilot studies using the same RNC cigarettes as in these studies
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94110
About this study
Official title: Safety of Nicotine Reduction Strategy
This is a 2-year study involving the progressive reduction in the nicotine content of cigarettes. The investigators believe that at the end of the study smokers of cigarettes with progressively reduced nicotine content will be "weaned" from nicotine. At the end of the study, the result will be a decreased level of nicotine dependence. When smokers are again free to choose any smoking behavior, they will smoke fewer cigarettes and/or have a greater interest in quitting compared to a control group that smokes their usual cigarettes.
Read the detailed description
This is a 2-year, randomized, two-arm study involving a 6-month period of progressive reduction in the nicotine content of cigarettes. During the first year (tapering/maintenance phases), subjects will smoke progressively reduced nicotine content (RNC) cigarettes over a period of six months, and then remain on the lowest nicotine content cigarette for an additional six months. Comparisons will be made with a control group in which subjects will smoke their usual normal nicotine yield cigarettes. There will be a one year follow-up phase during which subjects will be monitored and will be free to resume smoking a commercial cigarette of their choice, or to quit.
We hypothesize that smokers of cigarettes with progressively reduced nicotine content will experience a reduction in nicotine intake without compensatory oversmoking. This will serve to "wean" them from nicotine and result in a decreased level of nicotine dependence. Once this has occurred, subjects will then be able to maintain their reduced level of nicotine intake for the 6 months that they continue smoking the lowest level RNC cigarette. When they are again free to choose any smoking behavior (follow-up phase), as a result of the period of lowered dependence they will smoke fewer cigarettes and/or have a greater interest in quitting compared to the control group, whose level of nicotine dependence is hypothesized to be sustained throughout.
Primary Hypotheses:
- Nicotine intake will be lower for the RNC group than for the control group.
- Exposure to tobacco smoke gas phase constituents will be similar for the RNC and control group.
- Exposure to tobacco smoke tar constituents will be similar for the RNC and control group.
- Cardiovascular biomarkers of inflammation, platelet activation, endothelial dysfunction, and HDL cholesterol will be lower for the RNC group than for the control group.
- Cigarette consumption, as measured by cigarettes-per-day (CPD), will be lower for the RNC group than for the control group.
Secondary hypotheses:
- Over the course of tapering and maintenance and at follow-up, interest in quitting will be higher in the RNC group compared to the control group.
- At follow-up, measures of cigarette consumption, nicotine intake, and exposure to tobacco smoke combustion constituents will be lower for the RNC group compared to the control group.
- Conditions
- Nicotine Dependence, Tobacco Use Disorder
- Keywords
- Smoking, Tobacco, Nicotine
- Medical subject headings
- Tobacco Use Disorder, Smoking
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2005 (estimated)
- Study startJul 2005
- Primary completionMar 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neal L Benowitz, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00264342
- Sponsor's protocol ID
- R01CA078603-05A1
- Status last verified
- May 2013
- First submitted
- 9 Dec 2005
- Last updated
- 23 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Benowitz NL, Jacob P 3rd, Bernert JT, Wilson M, Wang L, Allen F, Dempsey D. Carcinogen exposure during short-term switching from regular to "light" cigarettes. Cancer Epidemiol Biomarkers Prev. 2005 Jun;14(6):1376-83. doi: 10.1158/1055-9965.EPI-04-0667.
PubMed 15941944Gray N, Henningfield JE, Benowitz NL, Connolly GN, Dresler C, Fagerstrom K, Jarvis MJ, Boyle P. Toward a comprehensive long term nicotine policy. Tob Control. 2005 Jun;14(3):161-5. doi: 10.1136/tc.2004.010272.
PubMed 15923465Hukkanen J, Jacob P 3rd, Benowitz NL. Metabolism and disposition kinetics of nicotine. Pharmacol Rev. 2005 Mar;57(1):79-115. doi: 10.1124/pr.57.1.3.
PubMed 15734728Arcavi L, Benowitz NL. Cigarette smoking and infection. Arch Intern Med. 2004 Nov 8;164(20):2206-16. doi: 10.1001/archinte.164.20.2206.
PubMed 15534156Swan GE, Benowitz NL, Jacob P 3rd, Lessov CN, Tyndale RF, Wilhelmsen K, Krasnow RE, McElroy MR, Moore SE, Wambach M. Pharmacogenetics of nicotine metabolism in twins: methods and procedures. Twin Res. 2004 Oct;7(5):435-48. doi: 10.1375/1369052042335269.
PubMed 15527659Benowitz NL, Gan Q, Goniewicz ML, Lu W, Xu J, Li X, Jacob P 3rd, Glantz S. Different profiles of carcinogen exposure in Chinese compared with US cigarette smokers. Tob Control. 2015 Dec;24(e4):e258-63. doi: 10.1136/tobaccocontrol-2014-051945. Epub 2014 Dec 22.
PubMed 25535294
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Nicotine Reduction Strategy
- ClinicalTrials.gov ID
- NCT00264342
- Acronym / sponsor ID
- R01CA078603-05A1
- Conditions
- Nicotine Dependence, Tobacco Use Disorder
- Keywords
- Smoking, Tobacco, Nicotine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 12 Dec 2005 (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 is a 2-year study involving the progressive reduction in the nicotine content of cigarettes. The investigators believe that at the end of the study smokers of cigarettes with progressively reduced nicotine content will be "weaned" from nicotine. At the end of the study, the result will be a decreased level of nicotine dependence. When smokers are again free to choose any smoking behavior, they will smoke fewer cigarettes and/or have a greater interest in quitting compared to a control group that smokes their usual cigarettes.
Detailed description
This is a 2-year, randomized, two-arm study involving a 6-month period of progressive reduction in the nicotine content of cigarettes. During the first year (tapering/maintenance phases), subjects will smoke progressively reduced nicotine content (RNC) cigarettes over a period of six months, and then remain on the lowest nicotine content cigarette for an additional six months. Comparisons will be made with a control group in which subjects will smoke their usual normal nicotine yield cigarettes. There will be a one year follow-up phase during which subjects will be monitored and will be free to resume smoking a commercial cigarette of their choice, or to quit.
We hypothesize that smokers of cigarettes with progressively reduced nicotine content will experience a reduction in nicotine intake without compensatory oversmoking. This will serve to "wean" them from nicotine and result in a decreased level of nicotine dependence. Once this has occurred, subjects will then be able to maintain their reduced level of nicotine intake for the 6 months that they continue smoking the lowest level RNC cigarette. When they are again free to choose any smoking behavior (follow-up phase), as a result of the period of lowered dependence they will smoke fewer cigarettes and/or have a greater interest in quitting compared to the control group, whose level of nicotine dependence is hypothesized to be sustained throughout.
Primary Hypotheses:
- Nicotine intake will be lower for the RNC group than for the control group.
- Exposure to tobacco smoke gas phase constituents will be similar for the RNC and control group.
- Exposure to tobacco smoke tar constituents will be similar for the RNC and control group.
- Cardiovascular biomarkers of inflammation, platelet activation, endothelial dysfunction, and HDL cholesterol will be lower for the RNC group than for the control group.
- Cigarette consumption, as measured by cigarettes-per-day (CPD), will be lower for the RNC group than for the control group.
Secondary hypotheses:
- Over the course of tapering and maintenance and at follow-up, interest in quitting will be higher in the RNC group compared to the control group.
- At follow-up, measures of cigarette consumption, nicotine intake, and exposure to tobacco smoke combustion constituents will be lower for the RNC group compared to the control group.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Health adults 18 and over
Key inclusion criteria (6 listed)
- Healthy on the basis of medical history and screening blood tests
- Current moderate-to-heavy smoker as determined by:
- Age 18-70 years
- Any racial/ethnic background
Key exclusion criteria (6 listed)
- Expressed desire to quit smoking within 6 months.
- Significant medical conditions (such as anemia, heart disease, uncontrolled hypertension, thyroid disease, diabetes, renal or liver impairment, glaucoma, or prostatic hypertrophy) or psychiatric condition (such as current major depression, history of schizophrenia or bipolar disorder, or current regular use of psychiatric medications such as major tranquilizers and antidepressants). Smokers with uncomplicated controlled hypertension may be enrolled.
- Pregnancy or lactation (by history)
- Current use of smokeless tobacco, pipes or cigars
- Alcohol abuse or illicit drug use (by history)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 23 May 2013.
- Background: PubMed 15941944Benowitz NL, Jacob P 3rd, Bernert JT, Wilson M, Wang L, Allen F, Dempsey D. Carcinogen exposure during short-term switching from regular to "light" cigarettes. Cancer Epidemiol Biomarkers Prev. 2005 Jun;14(6):1376-83. doi: 10.1158/1055-9965.EPI-04-0667.
- Background: PubMed 15923465Gray N, Henningfield JE, Benowitz NL, Connolly GN, Dresler C, Fagerstrom K, Jarvis MJ, Boyle P. Toward a comprehensive long term nicotine policy. Tob Control. 2005 Jun;14(3):161-5. doi: 10.1136/tc.2004.010272.
- Background: PubMed 15734728Hukkanen J, Jacob P 3rd, Benowitz NL. Metabolism and disposition kinetics of nicotine. Pharmacol Rev. 2005 Mar;57(1):79-115. doi: 10.1124/pr.57.1.3.
- Background: PubMed 15534156Arcavi L, Benowitz NL. Cigarette smoking and infection. Arch Intern Med. 2004 Nov 8;164(20):2206-16. doi: 10.1001/archinte.164.20.2206.
- Background: PubMed 15527659Swan GE, Benowitz NL, Jacob P 3rd, Lessov CN, Tyndale RF, Wilhelmsen K, Krasnow RE, McElroy MR, Moore SE, Wambach M. Pharmacogenetics of nicotine metabolism in twins: methods and procedures. Twin Res. 2004 Oct;7(5):435-48. doi: 10.1375/1369052042335269.
- Derived from this study: PubMed 25535294Benowitz NL, Gan Q, Goniewicz ML, Lu W, Xu J, Li X, Jacob P 3rd, Glantz S. Different profiles of carcinogen exposure in Chinese compared with US cigarette smokers. Tob Control. 2015 Dec;24(e4):e258-63. doi: 10.1136/tobaccocontrol-2014-051945. Epub 2014 Dec 22.
- UCSF Nicotine and Tobacco ResearchLink provided by the sponsor.
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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.
Neal L Benowitz, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nicotine Dependence and Tobacco Use Disorder, run by University of California, San Francisco 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 6 inclusion and 6 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 23 May 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00264342, which also lists 6 linked publications.
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 23 May 2013.