CompletedNCT02244918Updated Jan 9, 2019Results posted

Informing Tobacco Treatment Guidelines for African American Non-Daily Smokers

A Phase 4 interventional study of Nicotine Replacement Therapy and Smoking Cessation Counseling in Smoking Cessation, sponsored by University of Kansas Medical Center. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-09.

Sponsored by University of Kansas Medical Center · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 278
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Smoking Cessation

In context

Lead sponsor

University of Kansas Medical Center is the lead sponsor of 484 studies on the registry; 113 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

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

Exclusion Criteria:

Contraindications to behavioral counseling, nicotine gum, patch, or lozenge and unable to complete study procedures as determined by eligibility screening

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 278 participants (actual)

Study arms

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.
Drug: Nicotine Replacement Therapy · Behavioral: Smoking Cessation Counseling

Interventions

DrugNicotine Replacement Therapy
Participant has choice of from over-the-counter nicotine patch, nicotine gum or lozenge.
BehavioralSmoking Cessation Counseling

What researchers measure

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

Results

Posted Jan 9, 2019

Limitations and caveats

Findings may not generalize to non-daily smokers of other racial/ethnic groups. Low rates of cessation overall limited the potential for analyses of differential effects in sub-populations.

Participant flow

Participant flow — Overall Study
Milestone	Counseling Plus Nicotine Replacement Therapy	Counseling
Started	185	93
Week 12	160	83
Completed	185	93
Not completed	0	0

Outcome measures

PrimarySmoking 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
Reported as:: Count of participants · Participants

Smoking Abstinence
Participants	Counseling Plus Nicotine Replacement Therapy	Counseling
Smoking Abstinence	21	8

SecondarySmoking 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
Reported as:: Count of participants · Participants

Smoking Abstinence
Participants	Counseling Plus Nicotine Replacement Therapy	Counseling
Smoking Abstinence	13	6

SecondaryConcentration 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
Reported as:: Mean · ng/ml

Concentration of Urinary Cotinine
ng/ml	Counseling Plus Nicotine Replacement Therapy	Counseling
Baseline Nicotine Exposure	1538.3 ± 1622.0	1905.3 ± 1695.3
Week 26 Nicotine Exposure	1513.2 ± 1779.0	1649.3 ± 1443.9

SecondaryUrinary 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
Reported as:: Mean · pg/ml

Urinary Concentration of NNAL (4-(Methyl Nitrosamine)-1-(3-pyridyl)-1-butanol)
pg/ml	Counseling Plus Nicotine Replacement Therapy	Counseling
Baseline Carcinogen Exposure	100.9 ± 121.0	97.1 ± 97.8
Week 12 Carcinogen Exposure	47.6 ± 55.2	49.3 ± 47.3

SecondaryTotal Days Abstinent

Number of days abstinent from baseline through week 26.

Time frame:: Week 0-26
Reported as:: Mean · days abstinent in the past 30 days

Total Days Abstinent
days abstinent in the past 30 days	Counseling Plus Nicotine Replacement Therapy	Counseling
Baseline days abstinent from all tobacco	10.3 ± 6.4	10.4 ± 6.4
Week 4 days abstinent from all tobacco	17.4 ± 9.0	12.8 ± 9.2
Week 8 days abstinent from all tobacco	20.8 ± 9.0	19.8 ± 10.7
Week 12 days abstinent from all tobacco	19.8 ± 10.7	14.8 ± 11.1
Week 26 days abstinent from all tobacco	19.2 ± 11.2	15.1 ± 11.2

SecondaryCigarettes Used

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

Time frame:: Weeks 0-26
Reported as:: Mean · Cigarettes used in the past 30 days

Cigarettes Used
Cigarettes used in the past 30 days	Counseling Plus Nicotine Replacement Therapy	Counseling
Baseline	100.4 ± 102.1	85.8 ± 72.6
Week 4	43.2 ± 58.5	57.9 ± 51.8
Week 8	30.9 ± 52.3	53.3 ± 64.3
Week 12	37.1 ± 69.4	49.0 ± 56.6
Week 26	46.9 ± 81.0	48.7 ± 57.4

Adverse events

Collected over Adverse events were collected for 12 weeks.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Counseling Plus Nicotine Replacement Therapy	0/185 (0%)	0/185 (0%)	161/185 (87%)
Counseling	0/93 (0%)	0/93 (0%)	83/93 (89.2%)

Most frequent other events

Showing 10 of 19

Most frequent other events
Event	Counseling Plus Nicotine Replacement Therapy	Counseling
Tiredness/fatigueGeneral disorders	109/185	67/93
IrritabilityGeneral disorders	105/185	63/93
Nervous, restless, anxiousNervous system disorders	103/185	56/93
Sleeping ProblemsGeneral disorders	98/185	56/93
Changes in tasteGastrointestinal disorders	104/185	45/93
Heartburn, indigestion, hiccups or burpingGastrointestinal disorders	88/185	43/93
HeadacheGeneral disorders	87/185	44/93
Cold Sweats or increased sweatingEndocrine disorders	72/185	34/93
Bowel changes like constipation or diarrheaGastrointestinal disorders	70/185	36/93
Difficulty concentrating or confusion.mental weaknessPsychiatric disorders	63/185	34/93

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Counseling Plus Nicotine Replacement Therapy	Counseling	Total
Mean	48.6 ± 1.6	49 ± 11.8	48.7 ± 11.7

Sex: Female, Male
Sex: Female, Male(Participants)	Counseling Plus Nicotine Replacement Therapy	Counseling	Total
Female	94	47	141
Male	91	46	137

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Counseling Plus Nicotine Replacement Therapy	Counseling	Total
African American, Non-Hispanic	185	93	278

Region of Enrollment
Region of Enrollment(participants)	Counseling Plus Nicotine Replacement Therapy	Counseling	Total
United States	185	93	278

Cohabitation Status, Married or living with a partner
Cohabitation Status, Married or living with a partner(Participants)	Counseling Plus Nicotine Replacement Therapy	Counseling	Total
Count of participants	48	17	65

Employed Full-time
Employed Full-time(Participants)	Counseling Plus Nicotine Replacement Therapy	Counseling	Total
Count of participants	45	29	74

Education level of less than High School graduate
Education level of less than High School graduate(Participants)	Counseling Plus Nicotine Replacement Therapy	Counseling	Total
Count of participants	27	13	40

Has health insurance
Has health insurance(Participants)	Counseling Plus Nicotine Replacement Therapy	Counseling	Total
Count of participants	146	67	213

5 further baseline measures are reported on the registry.

Study locations

2 sites

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

References and documents

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. PubMed 29787858 ↗

Study documents

Protocol and statistical analysis plan · May 24, 2018

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02244918
Lead sponsor: University of Kansas Medical Center
Collaborators: Patient-Centered Outcomes Research Institute
Responsible party: Sponsor
First posted: Sep 19, 2014
Start date: May 2015
Primary completion: Nov 1, 2017
Completion: Mar 15, 2018
Results posted: Jan 9, 2019
Last update: Jan 9, 2019

Study contacts

Nikki Nollen, PhD

principal investigator · University of Kansas Medical Center

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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