Comparison of Low Yield Cigarettes in African Americans vs. Whites

NCT01058876 | Completed Phase 1

• 2 other identifiers: 10-00158NIDA DA002277
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cigarette Smoking

Keywords

Smoking; nicotine

Outcome Measures

Primary Outcomes (1)

• Nicotine clearance

  14 days

Study Arms (2)

Usual Cigarette

EXPERIMENTAL

African American and White Smokers will smoke their usual cigarette and also undergo an oral pharmacokinetics protocol after administration of 3 mg deuteriumlabeled nicotine and 5 mg deuterium-labeled cotinine.

Drug: Deuterated nicotine and cotinine

Low-yield Cigarette

EXPERIMENTAL

African American and White smokers will smoke a commercial cigarette with a machine-determined nicotine yield of approximately 50% of their "usual" brand.

Drug: Deuterated nicotine and cotinine

Interventions

Deuterated nicotine and cotinine DRUG

used as a marker for pharmacokinetic studies

Low-yield Cigarette; Usual Cigarette

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco, San Francisco General Hospital

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Cigarette Smoking; Smoking

Interventions

Cotinine

Condition Hierarchy (Ancestors)

Tobacco Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Neal L Benowitz, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2010
• First Posted: January 29, 2010
• Study Start: December 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: May 24, 2013

Record last verified: 2013-05

Locations

US (1)