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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 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: May 27, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Tobacco Dependence
Other: very low nicotine content cigarettes

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Project 1, Study 1: Investigating the Impact of Nicotine Using Spectrum Cigarettes

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Number of cigarettes smoked per day [ Time Frame: End of 6 week intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 840
Study Start Date: June 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

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

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

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

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

Other: very low nicotine content cigarettes
Usual brand

very low nicotine content cigarettes

Usual brand cigarettes (control condition)

Other: very low nicotine content cigarettes

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

    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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01681875

Contacts
Contact: Rachel L Denlinger, B.S 412-624-7865 rld9@pitt.edu
Contact: Tonya Lane, M.Ed. 412-624-6179 tjd50@pitt.edu

Locations
United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Natalie Nardone, PhD    415-514-1450      
Principal Investigator: Neal Benowitz, MD         
United States, Florida
Moffitt Cancer Center Active, not recruiting
Tampa, Florida, United States, 33617
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21224
Contact: Joseph Harrison, MS    410-550-3073      
Principal Investigator: Maxine Stitzer, PhD         
Sub-Investigator: Ryan Vandrey, PhD         
United States, Minnesota
University of Minnesota Medical School Duluth Active, not recruiting
Duluth, Minnesota, United States, 55812
University of Minnesota Masonic Cancer Center Active, not recruiting
Minneapolis, Minnesota, United States, 55414
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27705
Contact: Rachel Kozink    919-668-2963      
Principal Investigator: Francis J McClernon, PhD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Kathy Tang    215-746-7146      
Principal Investigator: Andrew Strasser, Ph.D         
University of Pittsburgh Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15260
United States, Rhode Island
Brown University Recruiting
Providence, Rhode Island, United States, 02912
Contact: Netesha Reid    401-863-6463      
Contact: Emily Xavier    401-863-6463      
Principal Investigator: Jennifer Tidey, PhD         
Sponsors and Collaborators
University of Pittsburgh
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
Investigators
Study Director: Eric C Donny, PhD University of Pittsburgh
  More Information

Publications:
Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01681875     History of Changes
Other Study ID Numbers: U54 DA031659, U54DA031659-01
Study First Received: August 30, 2012
Last Updated: May 27, 2014
Health Authority: United States: Food and Drug Administration
United States: Data and Safety Monitoring Board

Keywords provided by University of Pittsburgh:
Biomarkers of exposure
Compensatory smoking
Nicotine dependence
Reduced nicotine cigarettes
Tobacco withdrawal

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014