Project 2: Strategies for Reducing Nicotine Content in Cigarettes
Completed · Not applicable
Conditions studied: Nicotine Dependence, Tobacco Smoking
In brief
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.
Key facts
- Study ID
- NCT02139930
- Run by
- Wake Forest University Health Sciences
- People needed
- 1250
- Starts
- 2014-09-01
- Expected to finish
- 2017-03-14
- Last updated by the study team
- 2018-08-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18+
- Daily smokers who 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 level must indicate regular smoking)
You may not qualify if…
- Planned quit date in the next 30 days
- Currently seeking treatment for smoking cessation
- Currently using nicotine replacement therapies or other pharmacotherapies as cessation aid (non-cessation intermittent use acceptable)
- A quit attempt in the past 30 days resulting in greater than 3 days of abstinence
- Using other tobacco products or e-cigarettes 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)
- 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 (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.
- Positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, and PCP
- Marijuana will be tested for but will not be an exclusionary criterion.
- Participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded.
- 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 drinks per day (female/male))
- Pregnant, trying to become pregnant or breastfeeding
- Predominant use of 'roll your own cigarettes'
- 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 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.
Where it is running
- Mayo Clinic — Phoenix, Arizona, United States
- University of California San Francisco — San Francisco, California, United States
- Moffitt Cancer Center — Tampa, Florida, United States
- Johns Hopkins University — Baltimore, Maryland, United States
- University of Minnesota Medical School Duluth — Duluth, Minnesota, United States
- University of Minnesota — Minneapolis, Minnesota, United States
- Duke University — Durham, North Carolina, United States
- Oregon Research Institute — Eugene, Oregon, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
- MDAnderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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