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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: Smoking Cessation Counseling; Drug: Nicotine Replacement Therapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 278
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Missouri
    • Kansas City, Missouri, United States, 64130
      • Swope Health Central

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Counseling; Participants will go to smoking cessation counseling over 12 weeks. They will be asked to participated in 5 total counseling sessions.	Behavioral: Smoking Cessation Counseling
Experimental: Counseling Plus NRT; Participants will go to smoking cessation counseling over 12 weeks. They will be asked to participated in 5 total counseling sessions. In addition to counseling, participants in this group will also take 12 weeks of a nicotine replacement therapy(NRT) (like the patch, gum or lozenge) of their choice.	Behavioral: Smoking Cessation Counseling; Drug: Nicotine Replacement Therapy; Participant has choice of from over-the-counter nicotine patch, nicotine gum or lozenge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Total Days Abstinent	Number of days abstinent from baseline through week 26.	Week 0-26
Cigarettes Used	Cigarettes used in the past 30 days from baseline through week 26	Weeks 0-26

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Nikki Nollen, PhD, University of Kansas Medical Center

Publications and helpful links

General Publications

• Nollen NL, Cox LS, Mayo MS, Ellerbeck EF, Madhusudhana S, Ahluwalia JS. A randomized clinical trial of counseling and nicotine replacement therapy for treatment of African American non-daily smokers: Design, accrual, and baseline characteristics. Contemp Clin Trials. 2018 Jul;70:72-82. doi: 10.1016/j.cct.2018.05.011. Epub 2018 May 19.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): March 15, 2018

Study Registration Dates

• First Submitted: September 17, 2014
• First Submitted That Met QC Criteria: September 17, 2014
• First Posted (Estimate): September 19, 2014

Study Record Updates

• Last Update Posted (Actual): January 9, 2019
• Last Update Submitted That Met QC Criteria: December 20, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: STUDY00001602; AD-1310-08709 (Other Grant/Funding Number: Patient-Centered Outcomes Research Institute)