Status:
COMPLETED
Nicotine Metabolism and Low Nicotine Cigarettes
Lead Sponsor:
University of Pennsylvania
Conditions:
Smoking
Eligibility:
All Genders
21-65 years
Phase:
NA
Brief Summary
This study examines the effects of smoking low nicotine cigarettes in different groups of smokers. The investigators are focusing on differences in how smokers' bodies break down and eliminate nicotin...
Detailed Description
This study examines the effects of smoking low nicotine cigarettes on smoking behaviors and toxin exposure in fast and slow nicotine metabolizing smokers. We will recruit current smokers (split betwee...
Eligibility Criteria
Inclusion
- adults age 21-65.
- smoking at least 10 cigarettes per day.
- smoking daily for the last 5 years.
- Provide a baseline breath CO reading equal to or greater than 10 parts per million.
- smoke predominantly non-menthol filtered cigarettes (research cigarettes are only non-menthol).
- not currently using any other nicotine containing products such as cigars, smokeless tobacco, nicotine replacement therapies (patch or gum).
- are fluent in English and are capable of providing written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form.
- Participants who meet the inclusion/exclusion criteria and attend an Intake Visit for medical screening will be asked to provide a blood sample to determine NMR. Only those individuals who are characterized as slow or rapid, based on NMRs ≤ .26, or ≥ .42, will be eligible.
Exclusion
- use of any nicotine containing products other than cigarettes
- current or impending enrollment in smoking cessation program
- history in the last year or current treatment of substance abuse (other than nicotine dependence)
- positive drug screen for cocaine, methamphetamines or opiates for urine drug screen at intake session
- alcohol use greater than 25 standard drinks per week
- current or planned pregnancy or lactating
- history or current diagnosis of psychosis, bipolar disorder, mania, or schizophrenia
- current major depression (history of major depression but in remission for a minimum 6 months is eligible).
- serious or unstable disease within past year (e.g. cancer other than melanoma, heart disease)
- history or current diagnosis of COPD
- history of stroke or heart attack
- age less than 21 years- We wish to recruit smokers with well established smoking patterns and will restrict recruitment to those over 21
- age more than 65 years - smoking is often associated with cardiovascular and pulmonary obstructive diseases that manifest later in life. As smokers develop these problems, smoking behavior and biomarkers of harm may be affected therefore we will restrict enrollment to those under age 65
- provide baseline CO reading less than 10 at initial session
- current use (or use within past 14 days) of any medication that affects the biotransformation of nicotine, such as anticonvulsant drugs, rifampin, and disulfiram; or any psychoactive medications which can affect smoking behaviors
- any conditions viewed by the PI or study physician as creating a potential increased risk to a participant due to their participation will be reasons for exclusion
- at the discretion of the PI, any participants viewed as non-compliant will be excluded from further participation
- Smoke cigarettes with a filter size other than standard or slim sized as the topography mouthpieces are sized for standard filters and have an adapter for slim cigarettes only.
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2015
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT01898507
Start Date
September 1 2013
End Date
December 2 2015
Last Update
July 18 2018
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104