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Project 2: Strategies for Reducing Nicotine Content in Cigarettes

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02139930
First Posted: May 16, 2014
Last Update Posted: November 8, 2017
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.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Wake Forest University Health Sciences
  Purpose
The main goal of this project is to compare two different approaches to reducing levels of nicotine in cigarettes: an immediate reduction in nicotine content in cigarettes to non-addictive levels or a gradual reduction in nicotine content in cigarettes to non-addictive levels. These two approaches will then be contrasted to a group that continues to smoke cigarettes with nicotine content similar to conventional cigarettes.

Condition Intervention Phase
Nicotine Dependence Tobacco Smoking Behavioral: Normal Nicotine Control Group Behavioral: Immediate Nicotine Reduction Group Behavioral: Gradual Nicotine Reduction Group Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Project 2: Strategies for Reducing Nicotine Content in Cigarettes

Resource links provided by NLM:


Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • Toxicant exposure pattern: Expired air carbon monoxide [ Time Frame: 20-week treatment period ]
    Between group comparison of expired air carbon monoxide (CO) values at week 20 using baseline CO values as a covariate.

  • Toxicant exposure pattern: Urinary phenanthrene tetroal (Phe) [ Time Frame: 20-week treatment period ]
    Between group comparison of urinary phenanthrene tetroal values at week 20 using baseline values as a covariate.

  • Toxicant exposure pattern: Urinary mercapturic acids of acrolein [ Time Frame: 20-week treatment period ]
    Between group comparison of urinary mercapturic acid level at week 20 using baseline values as a covariate.


Secondary Outcome Measures:
  • Nicotine exposure: Total nicotine equivalents (TNE) [ Time Frame: End of treatment (Week 20) ]
    Between group comparison of urinary total nicotine equivalents at week 20 using baseline values as a covariate.

  • Other toxicant exposure: Tobacco specific nitrosamines-Total NNAL and NNN [ Time Frame: End of treatment (Week 20) ]
    Between group comparison of urinary total NNAL and NNN levels at week 20 using baseline values as a covariate.

  • Effect biomarker: C-Reactive protein-high sensitivity as an inflammation biomarker [ Time Frame: End of treatment (Week 20) ]
    Between group comparison of C-Reactive protein levels in serum at week 20 using baseline values as a covariate.

  • Measure of acceptability: Retention in study [ Time Frame: End of treatment (Week 20) ]
    Between group comparison of early termination from the study.

  • Measure of acceptability: Non-compliance [ Time Frame: End of treatment (Week 20) ]
    Between group comparison of use of non-study tobacco products.

  • Effect biomarker: 8-epi-PGF2α as a biomarker for oxidative stress [ Time Frame: End of treatment (Week 20) ]
    Between group comparison of 8-epi-PGF2α at week 20 using baseline values as a covariate.

  • Effect biomarker: White blood cells count as inflammation biomarker [ Time Frame: End of treatment (Week 20) ]
    Between group comparison of white blood cell count at week 20 using baseline values as a covariate.

  • Nicotine exposure: Urinary cotinine [ Time Frame: End of treatment (Week 20) ]
    Between group comparison of urinary total nicotine equivalents at week 20 using baseline values as a covariate.


Estimated Enrollment: 1250
Study Start Date: September 2014
Estimated Study Completion Date: March 2018
Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Normal Nicotine Control Group
These subjects will smoke normal nicotine content Spectrum brand cigarettes for 20 weeks.
Behavioral: Normal Nicotine Control Group
Participants will smoke experimental cigarettes for a period of 20-weeks.
Experimental: Immediate Nicotine Reduction Group
This group will immediately be switched to smoking very low nicotine content (VLNC) Spectrum brand cigarettes. They will smoke these cigarettes for 20 weeks.
Behavioral: Immediate Nicotine Reduction Group
Participants will smoke experimental cigarettes for a period of 20-weeks.
Experimental: Gradual Nicotine Reduction Group
This group will smoke progressively lower nicotine content Spectrum brand cigarettes for a period of one month each until they end up smoking the same VLNC cigarettes as the immediate reduction group.
Behavioral: Gradual Nicotine Reduction Group
Participants will smoke experimental cigarettes for a period of 20-weeks.

Detailed Description:
This project will be conducted to compare product use patterns and biomarkers of exposure between smokers who are assigned to a) gradual reduction in reduced nicotine content (RNC) cigarettes; b) immediate reduction to very low nicotine content (VLNC) cigarettes or c) normal nicotine content (NNC) cigarettes. The outcomes from this study will provide information on different approaches to reducing levels of nicotine in cigarettes and will determine the approach with the most optimal outcomes taking into account the balance between overall risk reduction (possibly maximized by abrupt switching) and compliance and acceptability (possibly maximized by gradual reduction of RNC cigarettes).
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18+
  2. Daily smokers who smoke an average of at least five cigarettes per day for at least 1 year
  3. Breath CO levels > 8 ppm (if ≤ 8 ppm, then NicAlert Strip level must indicate regular smoking)

Exclusion Criteria:

  1. Planned quit date in the next 30 days
  2. Currently seeking treatment for smoking cessation
  3. Currently using nicotine replacement therapies or other pharmacotherapies as cessation aid (non-cessation intermittent use acceptable)
  4. A quit attempt in the past 30 days resulting in greater than 3 days of abstinence
  5. Using other tobacco products or e-cigarettes more than 9 days in the past 30 days
  6. 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)
  7. Unstable psychiatric conditions (Any significant change in psychiatric symptoms during the past 3 months as determined by the licensed medical professional at each site)
  8. Schizophrenia and schizoaffective disorder
  9. Psychiatric medication changes (e.g., new prescriptions, changes in dosages, or discontinuation of medications) in the past 3 months that was a result of negative changes in symptoms.
  10. 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.
  11. Blood alcohol level > 0.01

    a. Participants failing the blood alcohol screen will be allowed to re-screen once.

  12. Binge drinking alcohol (more than 9 days in the past 30 days, 4/5 drinks per day (female/male))
  13. Pregnant, trying to become pregnant or breastfeeding
  14. Predominant use of 'roll your own cigarettes'
  15. CO reading >80 ppm
  16. Systolic BP greater than or equal to 160

    a. Participants failing for blood pressure will be allowed to re-screen once.

  17. Diastolic BP greater than or equal to 100

    a. Participants failing for blood pressure will be allowed to re-screen once.

  18. Systolic BP below 90 and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint)

    a. Participants failing for blood pressure will be allowed to re-screen once.

  19. Diastolic BP below 50 and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint)

    a. Participants failing for blood pressure will be allowed to re-screen once.

  20. Heart rate greater than or equal to 105 bpm

    a. Participants failing for heart rate will be allowed to re-screen once.

  21. Heart rate lower than 45 bpm and symptomatic (dizziness, extreme fatigue, difficulty thinking, inability to stand or walk, feeling faint)

    a. Participants failing for heart rate will be allowed to re-screen once.

  22. Indicating any suicidal ideation in the past month, suicide attempts in the past 5 years (if within past 5 to 10 years, requires physician approval), or score of >4 on the MINI suicide subscale
  23. Household member enrolled in the study concurrently.
  24. Inability to independently read and comprehend the consent form and other written study materials and measures because participants are required to complete parts of the protocol at home independently.
  25. Participated in prior study that involved reduced nicotine content cigarettes.
  26. Having participated in a research study during the past three months in a study that would impact baseline smoking or response to study products.
  27. Currently taking the following anticonvulsant medications:

    1. Phenytoin [Brand Name: Dilantin]
    2. Carbamazepine [Brand Name: Tegretol, Carbatrol, Equetro, Epitol]
    3. Oxcarbazepine [Brand Name: Trileptal]
    4. Primidone [Brand Name: Mysoline]
    5. Phenobarbital
  28. Currently taking the following medication:

    1. Bendamustine (Treanda)
    2. Clopidogrel (Plavix)
    3. Clozapine (Clozaril, FazaClo)
    4. Erlotinib (Tarceva)
    5. Flecainide (Tambocor)
    6. Fluvoxamine (Luvox)
    7. Irinotecan (Camptosar)
    8. Olanzapine (Zyprexa)
    9. Ropinirole (Requip)
    10. Tacrine (Cognex)
    11. Theophylline (Theo Dur, etc.)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139930


Locations
United States, Arizona
Mayo Clinic
Phoenix, Arizona, United States, 85054
United States, California
University of California San Francisco
San Francisco, California, United States, 94143
United States, Florida
Moffitt Cancer Center
Tampa, Florida, United States, 33617
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21224
United States, Minnesota
University of Minnesota Medical School Duluth
Duluth, Minnesota, United States, 55812
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27705
United States, Oregon
Oregon Research Institute
Eugene, Oregon, United States, 97403
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
MDAnderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Wake Forest University Health Sciences
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Eric Donny, PhD University of Pittsburgh
  More Information

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02139930     History of Changes
Other Study ID Numbers: U54 DA031659-P2
U54DA031659 ( U.S. NIH Grant/Contract )
First Submitted: May 12, 2014
First Posted: May 16, 2014
Last Update Posted: November 8, 2017
Last Verified: October 2017

Keywords provided by Wake Forest University Health Sciences:
smoking
nicotine reduction

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