Cigarette Smoking Clinical Trial
— 6162-AAPK2Official title:
Nicotine Regulation/Response to Low Yield Cigarettes in African-Americans vs. Whites
The investigators' general hypothesis is that African-Americans (AAs) smoke more for
positive reinforcement from nicotine with a "peak-seeking" pattern of smoking (smoking
individual cigarettes more intensively with greater intake of nicotine and tobacco smoke
toxins), while whites smoke more for negative reinforcement with a "trough-maintaining"
pattern (avoiding withdrawal by maintaining more consistent nicotine levels throughout the
day by means of a more regular smoking pattern). We, the investigators, believe that these
patterns are linked to identifiable racial differences in nicotine pharmacology.
For this study we hypothesize that if AAs behave more like nicotine "peak-seeker" while
whites behave more like nicotine "trough-maintainers", that AAs will respond to switching
from regular to low nicotine yield commercial cigarettes by smoking each cigarette
relatively more intensively with a relatively smaller increase in daily cigarette
consumption (cigarettes per day or CPD) as compared to whites.
Status | Completed |
Enrollment | 43 |
Est. completion date | January 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Sex: male or female (balanced numbers) - Age: 18- 65 - Race/ethnicity: African-American or White (based on two parents who self- identify as AA or White, respectively) - Smoking Status: Current daily smoker of at least 10 cigarettes per day; either menthol or non-menthol. Screening saliva cotinine level of > 100 ng/ml. Healthy by history and assessment of vital signs. Exclusion Criteria: - Evidence of cardiac disease by history - Recent or current history of asthma or severe allergic rhinitis - Hypertension (blood pressure [BP] >140/90 at screening after 5 min rest) - Serious medical or psychiatric condition or other condition requiring regular medication use - Lack of access to a refrigerator to store saliva specimens collected at home - Morbid obesity (body mass index [BMI]>35) - Current illicit drug use by history and tox screen (however subjects using marijuana may be included if they are not daily users and will agree to abstain from the time of screening until the end of the study) - Pregnancy or breastfeeding - Significant history of fainting, "bad veins", discomfort with blood draws - Current or recent alcohol or drug abuse - Inability to speak English/read forms or aversion to filling out forms - Multiple or unexplained "no shows" for screening/study visits or other noncompliance with study procedures |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Francisco, San Francisco General Hospital | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Nicotine clearance | 14 days | No |
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