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| ID | Type | Description | Link |
|---|---|---|---|
| U54DA031659-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| Masonic Cancer Center, University of Minnesota | OTHER |
| Brown University | OTHER |
| Johns Hopkins University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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 |
|
| 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 |
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| 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 |
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| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| very low nicotine content cigarettes | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of cigarettes smoked per day | End of 6 week intervention |
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Inclusion Criteria:
Exclusion Criteria:
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)
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
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:
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| Name | Affiliation | Role |
|---|---|---|
| Eric C Donny, PhD | University of Pittsburgh | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94143 | United States | ||
| Moffitt Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19446968 | Background | 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. | |
| 20078491 | Background | 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. |
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| 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 |
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| 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 |
|
| Usual brand | Other | very low nicotine content cigarettes Usual brand cigarettes (control condition) |
|
| Tampa |
| Florida |
| 33617 |
| United States |
| Johns Hopkins University | Baltimore | Maryland | 21224 | United States |
| University of Minnesota Medical School Duluth | Duluth | Minnesota | 55812 | United States |
| University of Minnesota Masonic Cancer Center | Minneapolis | Minnesota | 55414 | United States |
| Duke University | Durham | North Carolina | 27705 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15260 | United States |
| Brown University | Providence | Rhode Island | 02912 | United States |
| 22354905 | Background | 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. |
| 17222288 | Background | 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. |
| 30385649 | Derived | 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. |
| 29504780 | Derived | 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. |
| 27856940 | Derived | 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. |
| 26916879 | Derived | 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. |
| 26422724 | Derived | 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. |
| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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