NCT02244918

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
278

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2015

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2018

Completed
10 months until next milestone

Results Posted

Study results publicly available

January 9, 2019

Completed
Last Updated

January 9, 2019

Status Verified

December 1, 2018

Enrollment Period

2.5 years

First QC Date

September 17, 2014

Results QC Date

November 7, 2018

Last Update Submit

December 20, 2018

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Smoking Abstinence

    Week 26

  • Concentration of Urinary Cotinine

    Weeks 0, 26

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

    Weeks 0, 12

  • Total Days Abstinent

    Week 0-26

  • Cigarettes Used

    Weeks 0-26

Study Arms (2)

Counseling

ACTIVE COMPARATOR

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

Counseling Plus NRT

EXPERIMENTAL

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 TherapyBehavioral: Smoking Cessation Counseling

Interventions

Nicotine Replacement TherapyDRUG

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

Counseling Plus NRT
Smoking Cessation CounselingBEHAVIORAL
CounselingCounseling Plus NRT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • African American adults who are interested in quitting and whose smoking patterns meet criteria for non-daily smoking as determined by eligibility screening

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Swope Health Central

Kansas City, Missouri, 64130, United States

Location

Related Publications (1)

  • 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.

    PMID: 29787858DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

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.

Results Point of Contact

Title
Dr. Nicole Nollen
Organization
University of Kansas Medical Center
nnollen@kumc.edu
913-588-3784

Study Officials

  • Nikki Nollen, PhD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2014

First Posted

September 19, 2014

Study Start

May 1, 2015

Primary Completion

November 1, 2017

Study Completion

March 15, 2018

Last Updated

January 9, 2019

Results First Posted

January 9, 2019

Record last verified: 2018-12

Locations

US(2)