- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01898507
Nicotine Metabolism and Low Nicotine Cigarettes
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Low nicotine cigarettes
Participants will smoke their own brand cigarettes during a baseline 5 day period, followed by a 15-day period of smoking low nicotine content cigarette level 1: 0.25 mg nicotine content, followed by a 15-day period of smoking low nicotine content cigarette level 2: 0.08 mg nicotine content. Other: Low nicotine cigarettes |
15-day period of smoking low nicotine content cigarette level 1: 0.25 mg nicotine content, followed by a 15-day period of smoking low nicotine content cigarette level 2: 0.08 mg nicotine content.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Smoking topography- total puff volume
Time Frame: up to 35 days
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up to 35 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Daily cigarette consumption
Time Frame: Study day 0, 5, 10, 15, 20, 25, 30, 35
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Total number of cigarettes smoked each day.
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Study day 0, 5, 10, 15, 20, 25, 30, 35
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Urine nicotine metabolite measures
Time Frame: Assessed at Days 5, 20 and 35
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NNK, mercapturic acid metabolites, total nicotine equivalents
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Assessed at Days 5, 20 and 35
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Carbon monoxide measurements
Time Frame: Study day 0, 5, 10, 15, 20, 25, 30, 35
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Study day 0, 5, 10, 15, 20, 25, 30, 35
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 816228
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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