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

Completed · Not applicable

Conditions studied: Tobacco Dependence

In brief

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.

Key facts

Study ID

NCT01681875

Run by

Wake Forest University Health Sciences

People needed

839

Starts

2013-06-01

Expected to finish

2014-07-01

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+
• 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)

You may not qualify if…

• 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
• 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 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

Where it is running

• 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 Masonic Cancer Center — Minneapolis, Minnesota, United States
• Duke University — Durham, North Carolina, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Brown University — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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