Tobacco DependenceP1S1NCT01681875
Project 1, Study 1: Investigating the Impact of Nicotine Using Spectrum Cigarettes
A study testing very low nicotine content cigarettes in people with Tobacco Dependence, run by Wake Forest University Health Sciences at 9 sites in United States.
Trial summary
Project 1, Study 1 will evaluate the relationship between nicotine yield of very low nicotine content cigarettes and cigarettes smoked per day, nicotine exposure, discomfort/dysfunction, other health-related behaviors, nicotine/tobacco dependence, biomarkers of tobacco exposure, intention to quit, compensatory… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Dependence
- What is being tested?
- very low nicotine content cigarettes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 839 participants
- Where
- 9 sitesUnited States
- Study dates
- Jun 2013to Jul 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18+
- Smoke an average of at least five cigarettes per day for at least 1 year
- Breath CO levels > 8 ppm (if ≤ 8 ppm, then NicAlert Strip > 2)
Who cannot join
- Intention to quit smoking in the next 30 days
- Currently seeking treatment for smoking cessation
- Currently using nicotine replacement therapies or other pharmacotherapies as cessation aid (intermittent use acceptable)
- A quit attempt in the past 30 days resulting in greater than 3 days of abstinence
- Using other tobacco products more than 9 days in the past 30 days
- Significant unstable medical conditions (Any significant change in a serious medical condition occurring during the past 3 months including, cardiovascular disease, COPD, and cancer, as determined by the licensed medical professional at each site)
Show all 38Show fewer
- Significant unstable psychiatric conditions (Any significant change in psychiatric symptoms during the past 3 months as determined by the licensed medical professional at each site)
- Schizophrenia and schizoaffective disorder
- Psychiatric medication changes in the past 3 months
- Positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, and PCP
- Marijuana will be tested for but will not be an exclusionary criterion.
- Participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded.
- Participants failing the toxicology screen will be allowed to re-screen once.
- Blood alcohol level > 0.01
- Participants failing the blood alcohol screen will be allowed to re-screen once.
- Binge drinking alcohol (more than 9 days in the past 30 days, 4/5 in a 2 hour period(female/male))
- Pregnant or breastfeeding
- Smoking 'roll your own cigarettes' exclusively
- Currently taking anticonvulsant medication
- CO reading >80 ppm
- Systolic BP greater than or equal to 160
- Participants failing for blood pressure will be allowed to re-screen once.
- Diastolic BP greater than or equal to 100
- Participants failing for blood pressure will be allowed to re-screen once.
- Systolic BP below 90
- Participants failing for blood pressure will be allowed to re-screen once.
- Diastolic BP below 50
- Participants failing for blood pressure will be allowed to re-screen once.
- Heart rate greater than or equal to 115bpm
- Participants failing for heart rate will be allowed to re-screen once.
- Heart rate lower than 45bpm
- Participants failing for heart rate will be allowed to re-screen once.
- Indicating any suicidal ideation in the past month or suicide attempts in the past 10 years
- Inability to independently read and comprehend the consent form and other written study materials and measures
- Having participated in a research study during the past three months in which the participant:
- Smoked a cigarette that was not his/her usual brand cigarette for more than one day
- Used any tobacco products beyond normal use for more than one day
- Used any nicotine replacement products or smoking cessation medications for more than one day
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Johns Hopkins University
Baltimore, Maryland, 21224
University of Minnesota Medical School Duluth
Duluth, Minnesota, 55812
Duke University
Durham, North Carolina, 27705
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, 55414
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
Brown University
Providence, Rhode Island, 02912
University of California San Francisco
San Francisco, California, 94143
Moffitt Cancer Center
Tampa, Florida, 33617
About this study
Project 1, Study 1 will evaluate the relationship between nicotine yield of very low nicotine content cigarettes and cigarettes smoked per day, nicotine exposure, discomfort/dysfunction, other health-related behaviors, nicotine/tobacco dependence, biomarkers of tobacco exposure, intention to quit, compensatory smoking, other tobacco use, cigarette characteristics, cognitive function, cardiovascular function, and perceived risk. We will also consider differences between conditions in compliance with product use.
- Conditions
- Tobacco Dependence
- Being tested
- very low nicotine content cigarettes
- Keywords
- Biomarkers of exposure, Compensatory smoking, Nicotine dependence, Reduced nicotine cigarettes, Tobacco withdrawal
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
very low nicotine content cigarettesOther
| Study group | Role | What they receive |
|---|---|---|
| 0.8 mg nicotine with 9 mg tar | Experimental | very low nicotine content cigarettes
SPECTRUM Cigarette: 0.8 (±0.15) mg nicotine with 9 (±1.5) mg tar (standard nicotine and tar yields of commercially-available cigarettes; control condition) Receives: Other: very low nicotine content cigarettes |
| 0.26 mg nicotine with 9 mg tar | Experimental | very low nicotine content cigarettes
SPECTRUM Cigarette: 0.26 (±0.06) mg nicotine with 9 (±1.5) mg tar Receives: Other: very low nicotine content cigarettes |
| 0.12 mg nicotine with 9 mg tar | Experimental | very low nicotine content cigarettes
SPECTRUM Cigarette: 0.12 (±0.03) mg nicotine with 9 (±1.5) mg tar Receives: Other: very low nicotine content cigarettes |
| 0.07 mg nicotine with 9 mg tar | Experimental | very low nicotine content cigarettes
SPECTRUM Cigarette: 0.07 (±0.02) mg nicotine with 9 (±1.5) mg tar Receives: Other: very low nicotine content cigarettes |
| 0.03 mg nicotine with 9 mg tar | Experimental | very low nicotine content cigarettes
SPECTRUM Cigarette: 0.03 (±0.01) mg nicotine with 9 (±1.5) mg tar Receives: Other: very low nicotine content cigarettes |
| 0.04 mg nicotine with 13 mg tar | Experimental | very low nicotine content cigarettes
SPECTRUM Cigarette: 0.04 (±0.02) mg nicotine with 13 (±2) mg tar Receives: Other: very low nicotine content cigarettes |
| Usual brand | Other | very low nicotine content cigarettes
Usual brand cigarettes (control condition) Receives: Other: very low nicotine content cigarettes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cigarettes smoked per day
Measured: End of 6 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2012 (estimated)
- Study startJun 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Tobacco DependenceStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 839 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Masonic Cancer Center, University of Minnesota, Brown University, Johns Hopkins University, University of California, San Francisco, M.D. Anderson Cancer Center, University of Pennsylvania, Duke University, H. Lee Moffitt Cancer Center and Research Institute, University of Minnesota
- Responsible party
- Sponsor
- Investigators
- Eric C Donny, PhD, Study director, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01681875
- Sponsor's protocol ID
- U54DA031659
- Other IDs
- U54DA031659-01
- Acronym
- P1S1
- Status last verified
- Aug 2018
- First submitted
- 30 Aug 2012
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Donny EC, Jones M. Prolonged exposure to denicotinized cigarettes with or without transdermal nicotine. Drug Alcohol Depend. 2009 Sep 1;104(1-2):23-33. doi: 10.1016/j.drugalcdep.2009.01.021. Epub 2009 May 15.
PubMed 19446968Hatsukami DK, Kotlyar M, Hertsgaard LA, Zhang Y, Carmella SG, Jensen JA, Allen SS, Shields PG, Murphy SE, Stepanov I, Hecht SS. Reduced nicotine content cigarettes: effects on toxicant exposure, dependence and cessation. Addiction. 2010 Feb;105(2):343-55. doi: 10.1111/j.1360-0443.2009.02780.x.
PubMed 20078491Benowitz NL, Dains KM, Hall SM, Stewart S, Wilson M, Dempsey D, Jacob P 3rd. Smoking behavior and exposure to tobacco toxicants during 6 months of smoking progressively reduced nicotine content cigarettes. Cancer Epidemiol Biomarkers Prev. 2012 May;21(5):761-9. doi: 10.1158/1055-9965.EPI-11-0644. Epub 2012 Feb 21.
PubMed 22354905Donny EC, Houtsmuller E, Stitzer ML. Smoking in the absence of nicotine: behavioral, subjective and physiological effects over 11 days. Addiction. 2007 Feb;102(2):324-34. doi: 10.1111/j.1360-0443.2006.01670.x.
PubMed 17222288Denlinger-Apte RL, Tidey JW, Koopmeiners JS, Hatsukami DK, Smith TT, Pacek LR, McClernon FJ, Donny EC. Correlates of support for a nicotine-reduction policy in smokers with 6-week exposure to very low nicotine cigarettes. Tob Control. 2019 May;28(3):352-355. doi: 10.1136/tobaccocontrol-2018-054622. Epub 2018 Nov 1.
PubMed 30385649Dermody SS, McClernon FJ, Benowitz N, Luo X, Tidey JW, Smith TT, Vandrey R, Hatsukami D, Donny EC. Effects of reduced nicotine content cigarettes on individual withdrawal symptoms over time and during abstinence. Exp Clin Psychopharmacol. 2018 Jun;26(3):223-232. doi: 10.1037/pha0000179. Epub 2018 Mar 5.
PubMed 29504780Rupprecht LE, Koopmeiners JS, Dermody SS, Oliver JA, al'Absi M, Benowitz NL, Denlinger-Apte R, Drobes DJ, Hatsukami D, McClernon FJ, Pacek LR, Smith TT, Sved AF, Tidey J, Vandrey R, Donny EC. Reducing nicotine exposure results in weight gain in smokers randomised to very low nicotine content cigarettes. Tob Control. 2017 Mar;26(e1):e43-e48. doi: 10.1136/tobaccocontrol-2016-053301. Epub 2016 Nov 17.
PubMed 27856940Dermody SS, Tidey JW, Denlinger RL, Pacek LR, al'Absi M, Drobes DJ, Hatsukami DK, Vandrey R, Donny EC. The Impact of Smoking Very Low Nicotine Content Cigarettes on Alcohol Use. Alcohol Clin Exp Res. 2016 Mar;40(3):606-15. doi: 10.1111/acer.12980. Epub 2016 Feb 25.
PubMed 26916879Donny EC, Denlinger RL, Tidey JW, Koopmeiners JS, Benowitz NL, Vandrey RG, al'Absi M, Carmella SG, Cinciripini PM, Dermody SS, Drobes DJ, Hecht SS, Jensen J, Lane T, Le CT, McClernon FJ, Montoya ID, Murphy SE, Robinson JD, Stitzer ML, Strasser AA, Tindle H, Hatsukami DK. Randomized Trial of Reduced-Nicotine Standards for Cigarettes. N Engl J Med. 2015 Oct;373(14):1340-9. doi: 10.1056/NEJMsa1502403.
PubMed 26422724
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project 1, Study 1: Investigating the Impact of Nicotine Using Spectrum Cigarettes
- ClinicalTrials.gov ID
- NCT01681875
- Acronym / sponsor ID
- P1S1 / U54DA031659
- Conditions
- Tobacco Dependence
- Keywords
- Biomarkers of exposure, Compensatory smoking, Nicotine dependence, Reduced nicotine cigarettes, Tobacco withdrawal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 839 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Masonic Cancer Center, University of Minnesota, Brown University, Johns Hopkins University, University of California, San Francisco, M.D. Anderson Cancer Center, University of Pennsylvania, Duke University, H. Lee Moffitt Cancer Center and Research Institute, University of Minnesota
- Study start
- Jun 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 10 Sep 2012 (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.
Project 1, Study 1 will evaluate the relationship between nicotine yield of very low nicotine content cigarettes and cigarettes smoked per day, nicotine exposure, discomfort/dysfunction, other health-related behaviors, nicotine/tobacco dependence, biomarkers of tobacco exposure, intention to quit, compensatory smoking, other tobacco use, cigarette characteristics, cognitive function, cardiovascular function, and perceived risk. We will also consider differences between conditions in compliance with product use.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 0.8 mg nicotine with 9 mg tar | Experimental | Other: very low nicotine content cigarettesvery low nicotine content cigarettes SPECTRUM Cigarette: 0.8 (±0.15) mg nicotine with 9 (±1.5) mg tar (standard nicotine and tar yields of commercially-available cigarettes; control condition) |
| 0.26 mg nicotine with 9 mg tar | Experimental | Other: very low nicotine content cigarettesvery low nicotine content cigarettes SPECTRUM Cigarette: 0.26 (±0.06) mg nicotine with 9 (±1.5) mg tar |
| 0.12 mg nicotine with 9 mg tar | Experimental | Other: very low nicotine content cigarettesvery low nicotine content cigarettes SPECTRUM Cigarette: 0.12 (±0.03) mg nicotine with 9 (±1.5) mg tar |
| 0.07 mg nicotine with 9 mg tar | Experimental | Other: very low nicotine content cigarettesvery low nicotine content cigarettes SPECTRUM Cigarette: 0.07 (±0.02) mg nicotine with 9 (±1.5) mg tar |
| 0.03 mg nicotine with 9 mg tar | Experimental | Other: very low nicotine content cigarettesvery low nicotine content cigarettes SPECTRUM Cigarette: 0.03 (±0.01) mg nicotine with 9 (±1.5) mg tar |
| 0.04 mg nicotine with 13 mg tar | Experimental | Other: very low nicotine content cigarettesvery low nicotine content cigarettes SPECTRUM Cigarette: 0.04 (±0.02) mg nicotine with 13 (±2) mg tar |
| Usual brand | Other | Other: very low nicotine content cigarettesvery low nicotine content cigarettes Usual brand cigarettes (control condition) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18+
- Smoke an average of at least five cigarettes per day for at least 1 year
- Breath CO levels > 8 ppm (if ≤ 8 ppm, then NicAlert Strip > 2)
Key exclusion criteria (38 listed)
- Intention to quit smoking in the next 30 days
- Currently seeking treatment for smoking cessation
- Currently using nicotine replacement therapies or other pharmacotherapies as cessation aid (intermittent use acceptable)
- A quit attempt in the past 30 days resulting in greater than 3 days of abstinence
- Using other tobacco products more than 9 days in the past 30 days
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 |
|---|---|---|
| very low nicotine content cigarettes | Other | 0.03 mg nicotine with 9 mg tar, 0.04 mg nicotine with 13 mg tar, 0.07 mg nicotine with 9 mg tar, 0.12 mg nicotine with 9 mg tar, 0.26 mg nicotine with 9 mg tar, 0.8 mg nicotine with 9 mg tar, Usual brand |
Primary outcome
Number of cigarettes smoked per day
Time frame: End of 6 week intervention
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 15 Aug 2018.
- Background: PubMed 19446968Donny EC, Jones M. Prolonged exposure to denicotinized cigarettes with or without transdermal nicotine. Drug Alcohol Depend. 2009 Sep 1;104(1-2):23-33. doi: 10.1016/j.drugalcdep.2009.01.021. Epub 2009 May 15.
- Background: PubMed 20078491Hatsukami DK, Kotlyar M, Hertsgaard LA, Zhang Y, Carmella SG, Jensen JA, Allen SS, Shields PG, Murphy SE, Stepanov I, Hecht SS. Reduced nicotine content cigarettes: effects on toxicant exposure, dependence and cessation. Addiction. 2010 Feb;105(2):343-55. doi: 10.1111/j.1360-0443.2009.02780.x.
- Background: PubMed 22354905Benowitz NL, Dains KM, Hall SM, Stewart S, Wilson M, Dempsey D, Jacob P 3rd. Smoking behavior and exposure to tobacco toxicants during 6 months of smoking progressively reduced nicotine content cigarettes. Cancer Epidemiol Biomarkers Prev. 2012 May;21(5):761-9. doi: 10.1158/1055-9965.EPI-11-0644. Epub 2012 Feb 21.
- Background: PubMed 17222288Donny EC, Houtsmuller E, Stitzer ML. Smoking in the absence of nicotine: behavioral, subjective and physiological effects over 11 days. Addiction. 2007 Feb;102(2):324-34. doi: 10.1111/j.1360-0443.2006.01670.x.
- Derived from this study: PubMed 30385649Denlinger-Apte RL, Tidey JW, Koopmeiners JS, Hatsukami DK, Smith TT, Pacek LR, McClernon FJ, Donny EC. Correlates of support for a nicotine-reduction policy in smokers with 6-week exposure to very low nicotine cigarettes. Tob Control. 2019 May;28(3):352-355. doi: 10.1136/tobaccocontrol-2018-054622. Epub 2018 Nov 1.
- Derived from this study: PubMed 29504780Dermody SS, McClernon FJ, Benowitz N, Luo X, Tidey JW, Smith TT, Vandrey R, Hatsukami D, Donny EC. Effects of reduced nicotine content cigarettes on individual withdrawal symptoms over time and during abstinence. Exp Clin Psychopharmacol. 2018 Jun;26(3):223-232. doi: 10.1037/pha0000179. Epub 2018 Mar 5.
- Derived from this study: PubMed 27856940Rupprecht LE, Koopmeiners JS, Dermody SS, Oliver JA, al'Absi M, Benowitz NL, Denlinger-Apte R, Drobes DJ, Hatsukami D, McClernon FJ, Pacek LR, Smith TT, Sved AF, Tidey J, Vandrey R, Donny EC. Reducing nicotine exposure results in weight gain in smokers randomised to very low nicotine content cigarettes. Tob Control. 2017 Mar;26(e1):e43-e48. doi: 10.1136/tobaccocontrol-2016-053301. Epub 2016 Nov 17.
- Derived from this study: PubMed 26916879Dermody SS, Tidey JW, Denlinger RL, Pacek LR, al'Absi M, Drobes DJ, Hatsukami DK, Vandrey R, Donny EC. The Impact of Smoking Very Low Nicotine Content Cigarettes on Alcohol Use. Alcohol Clin Exp Res. 2016 Mar;40(3):606-15. doi: 10.1111/acer.12980. Epub 2016 Feb 25.
- Derived from this study: PubMed 26422724Donny EC, Denlinger RL, Tidey JW, Koopmeiners JS, Benowitz NL, Vandrey RG, al'Absi M, Carmella SG, Cinciripini PM, Dermody SS, Drobes DJ, Hecht SS, Jensen J, Lane T, Le CT, McClernon FJ, Montoya ID, Murphy SE, Robinson JD, Stitzer ML, Strasser AA, Tindle H, Hatsukami DK. Randomized Trial of Reduced-Nicotine Standards for Cigarettes. N Engl J Med. 2015 Oct;373(14):1340-9. doi: 10.1056/NEJMsa1502403.
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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.
Eric C Donny, PhD study director
University of Pittsburgh
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing very low nicotine content cigarettes in people with Tobacco Dependence, run by Wake Forest University Health Sciences at 9 sites 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 3 inclusion and 38 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 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 cigarettes smoked per day (time frame: End of 6 week intervention). 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 NCT01681875, which also lists 9 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 15 Aug 2018.