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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01681875
Recruitment Status : Completed
First Posted : September 10, 2012
Last Update Posted : August 15, 2018
Sponsor:
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
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Tracking Information
First Submitted Date  ICMJE August 30, 2012
First Posted Date  ICMJE September 10, 2012
Last Update Posted Date August 15, 2018
Study Start Date  ICMJE June 2013
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2012)
Number of cigarettes smoked per day [ Time Frame: End of 6 week intervention ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Project 1, Study 1: Investigating the Impact of Nicotine Using Spectrum Cigarettes
Official Title  ICMJE Project 1, Study 1: Investigating the Impact of Nicotine Using Spectrum Cigarettes
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Tobacco Dependence
Intervention  ICMJE Other: very low nicotine content cigarettes
Study Arms  ICMJE
  • Experimental: 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)

    Intervention: Other: very low nicotine content cigarettes
  • Experimental: 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

    Intervention: Other: very low nicotine content cigarettes
  • Experimental: 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

    Intervention: Other: very low nicotine content cigarettes
  • Experimental: 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

    Intervention: Other: very low nicotine content cigarettes
  • Experimental: 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

    Intervention: Other: very low nicotine content cigarettes
  • Experimental: 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

    Intervention: Other: very low nicotine content cigarettes
  • Usual brand

    very low nicotine content cigarettes

    Usual brand cigarettes (control condition)

    Intervention: Other: very low nicotine content cigarettes
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 11, 2018)
839
Original Estimated Enrollment  ICMJE
 (submitted: September 5, 2012)
840
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01681875
Other Study ID Numbers  ICMJE U54DA031659( U.S. NIH Grant/Contract )
U54DA031659-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wake Forest University Health Sciences
Study Sponsor  ICMJE Wake Forest University Health Sciences
Collaborators  ICMJE
  • 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
Investigators  ICMJE
Study Director: Eric C Donny, PhD University of Pittsburgh
PRS Account Wake Forest University Health Sciences
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP