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Completed

NCT Number: NCT02244918

Informing Tobacco Treatment Guidelines for African American Non-Daily Smokers

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Kansas Medical Center, Kansas City, Kansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nicotine Replacement Therapy

Drug

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

Smoking Cessation Counseling

Behavioral

Primary outcomes

  1. Smoking Abstinence

    Time frame: Week 12

    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.

Secondary outcomes

  1. Smoking Abstinence

    Time frame: Week 26

    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.

  2. Concentration of Urinary Cotinine

    Time frame: Weeks 0, 26

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

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

    Time frame: Weeks 0, 12

    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.

  4. Total Days Abstinent

    Time frame: Week 0-26

    Number of days abstinent from baseline through week 26.

  5. Cigarettes Used

    Time frame: Weeks 0-26

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

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Sep 19, 2014
Registry last updated
Jan 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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