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Project 1, Study 1: Investigating the Impact of Nicotine Using Spectrum Cigarettes (P1S1)

Primary Purpose

Tobacco Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
very low nicotine content cigarettes
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Tobacco Dependence focused on measuring Biomarkers of exposure, Compensatory smoking, Nicotine dependence, Reduced nicotine cigarettes, Tobacco withdrawal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

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

    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

Sites / Locations

  • University of California San Francisco
  • Moffitt Cancer Center
  • Johns Hopkins University
  • University of Minnesota Medical School Duluth
  • University of Minnesota Masonic Cancer Center
  • Duke University
  • University of Pennsylvania
  • University of Pittsburgh
  • Brown University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Other

Arm Label

0.8 mg nicotine with 9 mg tar

0.26 mg nicotine with 9 mg tar

0.12 mg nicotine with 9 mg tar

0.07 mg nicotine with 9 mg tar

0.03 mg nicotine with 9 mg tar

0.04 mg nicotine with 13 mg tar

Usual brand

Arm Description

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 SPECTRUM Cigarette: 0.26 (±0.06) mg nicotine with 9 (±1.5) 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 SPECTRUM Cigarette: 0.07 (±0.02) mg nicotine with 9 (±1.5) 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 SPECTRUM Cigarette: 0.04 (±0.02) mg nicotine with 13 (±2) mg tar

very low nicotine content cigarettes Usual brand cigarettes (control condition)

Outcomes

Primary Outcome Measures

Number of cigarettes smoked per day

Secondary Outcome Measures

Full Information

First Posted
August 30, 2012
Last Updated
August 13, 2018
Sponsor
Wake Forest University Health Sciences
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
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1. Study Identification

Unique Protocol Identification Number
NCT01681875
Brief Title
Project 1, Study 1: Investigating the Impact of Nicotine Using Spectrum Cigarettes
Acronym
P1S1
Official Title
Project 1, Study 1: Investigating the Impact of Nicotine Using Spectrum Cigarettes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Dependence
Keywords
Biomarkers of exposure, Compensatory smoking, Nicotine dependence, Reduced nicotine cigarettes, Tobacco withdrawal

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
839 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.8 mg nicotine with 9 mg tar
Arm Type
Experimental
Arm Description
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)
Arm Title
0.26 mg nicotine with 9 mg tar
Arm Type
Experimental
Arm Description
very low nicotine content cigarettes SPECTRUM Cigarette: 0.26 (±0.06) mg nicotine with 9 (±1.5) mg tar
Arm Title
0.12 mg nicotine with 9 mg tar
Arm Type
Experimental
Arm Description
very low nicotine content cigarettes SPECTRUM Cigarette: 0.12 (±0.03) mg nicotine with 9 (±1.5) mg tar
Arm Title
0.07 mg nicotine with 9 mg tar
Arm Type
Experimental
Arm Description
very low nicotine content cigarettes SPECTRUM Cigarette: 0.07 (±0.02) mg nicotine with 9 (±1.5) mg tar
Arm Title
0.03 mg nicotine with 9 mg tar
Arm Type
Experimental
Arm Description
very low nicotine content cigarettes SPECTRUM Cigarette: 0.03 (±0.01) mg nicotine with 9 (±1.5) mg tar
Arm Title
0.04 mg nicotine with 13 mg tar
Arm Type
Experimental
Arm Description
very low nicotine content cigarettes SPECTRUM Cigarette: 0.04 (±0.02) mg nicotine with 13 (±2) mg tar
Arm Title
Usual brand
Arm Type
Other
Arm Description
very low nicotine content cigarettes Usual brand cigarettes (control condition)
Intervention Type
Other
Intervention Name(s)
very low nicotine content cigarettes
Primary Outcome Measure Information:
Title
Number of cigarettes smoked per day
Time Frame
End of 6 week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) 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 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 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric C Donny, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Study Director
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33617
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
University of Minnesota Medical School Duluth
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55812
Country
United States
Facility Name
University of Minnesota Masonic Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55414
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States
Facility Name
Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19446968
Citation
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.
Results Reference
background
PubMed Identifier
20078491
Citation
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.
Results Reference
background
PubMed Identifier
22354905
Citation
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.
Results Reference
background
PubMed Identifier
17222288
Citation
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.
Results Reference
background
PubMed Identifier
30385649
Citation
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.
Results Reference
derived
PubMed Identifier
29504780
Citation
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.
Results Reference
derived
PubMed Identifier
27856940
Citation
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.
Results Reference
derived
PubMed Identifier
26916879
Citation
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.
Results Reference
derived
PubMed Identifier
26422724
Citation
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.
Results Reference
derived

Learn more about this trial

Project 1, Study 1: Investigating the Impact of Nicotine Using Spectrum Cigarettes

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