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

This study is currently recruiting participants.
Verified April 2014 by University of Pittsburgh
Sponsor:
Collaborators:
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 - Clinical and Translational Science Institute
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01681875
First received: August 30, 2012
Last updated: April 9, 2014
Last verified: April 2014

August 30, 2012
April 9, 2014
June 2013
July 2014   (final data collection date for primary outcome measure)
Number of cigarettes smoked per day [ Time Frame: End of 6 week intervention ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01681875 on ClinicalTrials.gov Archive Site
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Project 1, Study 1: Investigating the Impact of Nicotine Using Spectrum Cigarettes
Project 1, Study 1: Investigating the Impact of Nicotine Using Spectrum Cigarettes

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Tobacco Dependence
Other: very low nicotine content cigarettes
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
840
July 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Rachel L Denlinger, B.S 412-624-7865 rld9@pitt.edu
Contact: Tonya Lane, M.Ed. 412-624-6179 tjd50@pitt.edu
United States
 
NCT01681875
U54 DA031659, U54DA031659-01
Yes
University of Pittsburgh
University of Pittsburgh
  • 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 - Clinical and Translational Science Institute
Study Director: Eric C Donny, PhD University of Pittsburgh
University of Pittsburgh
April 2014

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