Overview

Comparison of Low Yield Cigarettes in African Americans vs. Whites

Status:
Completed
Trial end date:
2013-01-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of California, San Francisco
Treatments:
Nicotine
Criteria
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