Project 1, Study 1: Investigating the Impact of Nicotine Using Spectrum Cigarettes
NCT ID: NCT01681875
Last Updated: 2018-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
839 participants
INTERVENTIONAL
2013-06-30
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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0.8 mg nicotine with 9 mg tar
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)
very low nicotine content cigarettes
0.26 mg nicotine with 9 mg tar
very low nicotine content cigarettes
SPECTRUM Cigarette: 0.26 (±0.06) mg nicotine with 9 (±1.5) mg tar
very low nicotine content cigarettes
0.12 mg nicotine with 9 mg tar
very low nicotine content cigarettes
SPECTRUM Cigarette: 0.12 (±0.03) mg nicotine with 9 (±1.5) mg tar
very low nicotine content cigarettes
0.07 mg nicotine with 9 mg tar
very low nicotine content cigarettes
SPECTRUM Cigarette: 0.07 (±0.02) mg nicotine with 9 (±1.5) mg tar
very low nicotine content cigarettes
0.03 mg nicotine with 9 mg tar
very low nicotine content cigarettes
SPECTRUM Cigarette: 0.03 (±0.01) mg nicotine with 9 (±1.5) mg tar
very low nicotine content cigarettes
0.04 mg nicotine with 13 mg tar
very low nicotine content cigarettes
SPECTRUM Cigarette: 0.04 (±0.02) mg nicotine with 13 (±2) mg tar
very low nicotine content cigarettes
Usual brand
very low nicotine content cigarettes
Usual brand cigarettes (control condition)
very low nicotine content cigarettes
Interventions
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very low nicotine content cigarettes
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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)
* 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
1. Marijuana will be tested for but will not be an exclusionary criterion.
2. Participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded.
3. Participants failing the toxicology screen will be allowed to re-screen once.
* Blood alcohol level \> 0.01
a. 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
a. Participants failing for blood pressure will be allowed to re-screen once.
* Diastolic BP greater than or equal to 100
a. Participants failing for blood pressure will be allowed to re-screen once.
* Systolic BP below 90
a. Participants failing for blood pressure will be allowed to re-screen once.
* Diastolic BP below 50
a. Participants failing for blood pressure will be allowed to re-screen once.
* Heart rate greater than or equal to 115bpm
a. Participants failing for heart rate will be allowed to re-screen once.
* Heart rate lower than 45bpm
a. 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:
1. Smoked a cigarette that was not his/her usual brand cigarette for more than one day
2. Used any tobacco products beyond normal use for more than one day
3. Used any nicotine replacement products or smoking cessation medications for more than one day
18 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Masonic Cancer Center, University of Minnesota
OTHER
Brown University
OTHER
Johns Hopkins University
OTHER
University of California, San Francisco
OTHER
M.D. Anderson Cancer Center
OTHER
University of Pennsylvania
OTHER
Duke University
OTHER
H. Lee Moffitt Cancer Center and Research Institute
OTHER
University of Minnesota
OTHER
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Eric C Donny, PhD
Role: STUDY_DIRECTOR
University of Pittsburgh
Locations
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University of California San Francisco
San Francisco, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
Johns Hopkins University
Baltimore, Maryland, United States
University of Minnesota Medical School Duluth
Duluth, Minnesota, United States
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, United States
Duke University
Durham, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Brown University
Providence, Rhode Island, United States
Countries
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References
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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.
Hatsukami 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.
Benowitz 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.
Donny 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.
Denlinger-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.
Dermody 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.
Rupprecht 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.
Dermody 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.
Donny 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.
Other Identifiers
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