Informing Tobacco Treatment Guidelines for African American Non-Daily Smokers

University of Kansas Medical Center278 enrolled

Overview

The researchers are testing if counseling alone or counseling plus over-the-counter nicotine replacement therapies (NRT), like the patch,gum, or lozenge, helps African American non-daily smokers quit smoking.

Non-daily smokers represent a growing number of racial/ethnic minority smokers. 1 out of 4 African Americans are non-daily smokers. African Americans seem to have a harder time quitting and have greater medical problems related to smoking even at lighter usage rates compared to Whites. Current tobacco treatment guidelines target daily smokers. There are no guidelines for non-daily smokers. This study will allow the researchers to explore treatment options for African American non-daily smokers and find out if some treatments work better than others. Participation in this study will last about 6 months. Over this course of time, participants will be asked to visit the study location 3 times and will talk with a member of the study team on the phone 4 times.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

278

Conditions

Smoking Cessation

Interventions

Nicotine Replacement TherapyDRUG

Participant has choice of from over-the-counter nicotine patch, nicotine gum or lozenge.

Smoking Cessation CounselingBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * African American adults who are interested in quitting and whose smoking patterns meet criteria for non-daily smoking as determined by eligibility screening Exclusion Criteria: * Contraindications to behavioral counseling, nicotine gum, patch, or lozenge and unable to complete study procedures as determined by eligibility screening

Locations (2)

University of Kansas Medical Center

Kansas City, Kansas, United States

Swope Health Central

Kansas City, Missouri, United States

Outcomes

Primary Outcomes

Smoking Abstinence

Biochemically confirmed 30-day point prevalence abstinence at Week 12 using urine anabasine and anatabine, with the recommended cut-off of 2 ng/ml to differentiate smokers from non-smokers.

Time frame: Week 12

Secondary Outcomes

Smoking Abstinence

Biochemically confirmed 30-day point prevalence abstinence at Week 26 using urinary cotinine, with the recommended cut-off of 50 ng/ml to differentiate smokers from non-smokers.

Time frame: Week 26

Concentration of Urinary Cotinine

Measured by urinary cotinine, a biochemical marker of nicotine intake, sampled from participants at weeks 0 and 26.

Time frame: Weeks 0, 26

Urinary Concentration of NNAL (4-(Methyl Nitrosamine)-1-(3-pyridyl)-1-butanol)

Measured by a change in NNAL (4-(methyl nitrosamine)-1-(3-pyridyl)-1-butanol),a biochemical marker of tobacco-specific carcinogen exposure. Levels assessed by urine sample from each participant and Weeks 0 and 12.

Time frame: Weeks 0, 12

Total Days Abstinent

Number of days abstinent from baseline through week 26.

Time frame: Week 0-26

Cigarettes Used

Cigarettes used in the past 30 days from baseline through week 26

Time frame: Weeks 0-26

Data from ClinicalTrials.gov

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