Informing Tobacco Treatment Guidelines for African American Non-Daily Smokers

Smoking Cessation Clinical Trial

Official title:

Informing Tobacco Treatment Guidelines for African American Non-Daily Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02244918
• Other study ID #: STUDY00001602
• Secondary ID: AD-1310-08709
• Status: Completed
• Phase: Phase 4
• Start date: May 2015
• Est. completion date: March 15, 2018

Study information

• Verified date: December 2018
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: March 15, 2018
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• Nicotine Replacement Therapy
Participant has choice of from over-the-counter nicotine patch, nicotine gum or lozenge.

Behavioral:
• Smoking Cessation Counseling

Locations

Country	Name	City	State
United States	Swope Health Central	Kansas City	Missouri
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 12
Secondary	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.	Week 26
Secondary	Concentration of Urinary Cotinine	Measured by urinary cotinine, a biochemical marker of nicotine intake, sampled from participants at weeks 0 and 26.	Weeks 0, 26
Secondary	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.	Weeks 0, 12
Secondary	Total Days Abstinent	Number of days abstinent from baseline through week 26.	Week 0-26
Secondary	Cigarettes Used	Cigarettes used in the past 30 days from baseline through week 26	Weeks 0-26