Advancing Tobacco Use Treatment for African American Smokers

NCT02360631 | Completed Phase 4 Results

• 2 other identifiers: STUDY00000721R01DA035796
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to examine whether or not providing Chantix (varenicline) will help African American smokers quit smoking.

Conditions

Smoking Cessation

Keywords

smoking; quit smoking; smoking treatment

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Smoking Abstinence at Month 6

  Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Month 6 visit

  Month 6

Secondary Outcomes (2)

• Number of Participants With Smoking Abstinence at Week 12

  Week 12

• Number of Participants With Smoking Abstinence at Week 26

  Week 26

Study Arms (2)

Chantix (varenicline)

EXPERIMENTAL

Participants will receive 1mg pills to take twice a day for 12 weeks.

Drug: Chantix

Placebo

PLACEBO COMPARATOR

Participants will receive a placebo pill to take twice a day for 12 weeks.

Drug: Placebo

Interventions

Chantix DRUG

A drug used to treat nicotine addiction.Chantix is approved by the FDA to be given to help people quit smoking.

Also known as: Varenicline

Chantix (varenicline)

Placebo DRUG

Health education counseling will be provided to all participants.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-identified African American
• Smokes ≥ 1 cigarette per day (cpd)
• Smoke on ≥ 25 days of the past 30 days
• Functioning telephone
• Interested in quitting smoking
• Interested in taking 3 months of varenicline
• Willing to complete all study visits

You may not qualify if:

• Renal impairment
• Evidence or history of clinically significant allergic reactions to varenicline
• A cardiovascular event in the past month
• History of alcohol or drug dependence in the past year
• Major depressive disorder in the last year requiring treatment
• History of panic disorder, psychosis, bipolar disorder, or eating disorders
• Use of tobacco products other than cigarettes in past 30 days
• Use of pharmacotherapy in the month prior to enrollment, including prior use of varenicline
• Pregnant, contemplating getting pregnant, or breastfeeding
• Plans to move from Kansas City during the treatment and follow-up phase
• Another household member enrolled in the study
• Evidence of current severe major depressive disorder or suicidal ideation

Sponsors & Collaborators

• Lisa Sanderson Cox, PhD: lead
• National Institute on Drug Abuse (NIDA): collaborator

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 (3)

• Lambart L, Nollen NL, Mayo MS, Funk O, Leavens E, Cruvinel E, Brown A, Ahluwalia JS, Sanderson Cox L. The impact of blunt use on smoking abstinence among Black adults: Secondary analysis from randomized controlled smoking cessation clinical trial. Addict Behav. 2024 Jan;148:107877. doi: 10.1016/j.addbeh.2023.107877. Epub 2023 Oct 4.

  PMID: 37804748 DERIVED

• Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

  PMID: 37142273 DERIVED

• Cox LS, Nollen NL, Mayo MS, Faseru B, Greiner A, Ellerbeck EF, Krebill R, Tyndale RF, Benowitz NL, Ahluwalia JS. Effect of Varenicline Added to Counseling on Smoking Cessation Among African American Daily Smokers: The Kick It at Swope IV Randomized Clinical Trial. JAMA. 2022 Jun 14;327(22):2201-2209. doi: 10.1001/jama.2022.8274.

  PMID: 35699705 DERIVED

MeSH Terms

Conditions

Smoking Cessation; Smoking

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Limitations and Caveats

Findings cannot be generalized to non-US Blacks and require replication with smokers outside the Midwestern US.

Results Point of Contact

• Title: Lisa Sanderson Cox
• Organization: University of Kansas Medical Center

lcox@kumc.edu

913-588-2643

Study Officials

• Lisa Sanderson Cox, 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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: February 4, 2015
• First Posted: February 10, 2015
• Study Start: July 29, 2015
• Primary Completion: July 12, 2018
• Study Completion: July 12, 2018
• Last Updated: July 15, 2020
• Results First Posted: July 24, 2019

Record last verified: 2020-07

Locations

US (2)