Project 2: Strategies for Reducing Nicotine Content in Cigarettes



Status:Completed
Conditions:Smoking Cessation, Smoking Cessation, Tobacco Consumers
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:8/17/2018
Start Date:September 2014
End Date:March 14, 2017

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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.

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).

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.)
We found this trial at
10
sites
Houston, Texas 77030
Principal Investigator: Paul Cinciripini, Ph.D.
Phone: 713-745-2658
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Maxine Stitzer, Ph.D.
Phone: 410-550-0159
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: Joseph McClernon, Ph.D.
Phone: 919-668-2963
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Dorothy Hatsukami, Ph.D
Phone: 612-624-5178
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Duluth, Minnesota 55812
Principal Investigator: Mustafa al'Absi, Ph.D.
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Duluth, MN
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Eugene, Oregon 97403
Principal Investigator: Herb Severson, Ph.D.
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Eugene, OR
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Andrew Strasser, Ph.D.
Phone: 215-746-7146
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, PA
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5777 East Mayo Boulevard
Phoenix, Arizona 85054
(480) 515-6296
Principal Investigator: Scott Leischow, Ph.D.
Phone: 480-342-2665
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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San Francisco, California 94143
Principal Investigator: Neal Benowitz, M.D.
Phone: 415-514-1450
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Tampa, Florida 33612
Principal Investigator: David Drobes, Ph.D.
Phone: 813-745-1757
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Tampa, FL
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