Individualizing Pharmacotherapy for African American Smokers

NCT03897439 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: Study0000142310R01DA046576
• Study Type: interventional
• Target: 392
• Locations: 1 country
• Sites: 1

Brief Summary

Improving cessation outcomes for African American smokers through the use of novel, empirically-based strategies is a national health priority. In the vast majority of smoking cessation studies and in clinical practice, when smokers are provided a medication to help them quit, they are expected to continue that medication regardless of how well it is working. This study will assess whether African Americans smokers respond better if they continue with a single treatment or if their treatment is changed when that treatment is not working.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Biochemically Verified Smoking Abstinence at Week 12

  Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 12 visit. This will evaluate the short-term efficacy of optimized pharmacotherapy for smoking cessation in African American smokers.

  Week 12

Secondary Outcomes (2)

• Number of Participants With Biochemically Verified Smoking Abstinence at Week 18

  Week 18

• Number of Participants With Biochemically Verified Smoking Abstinence at Week 26

  Week 26

Study Arms (2)

Usual Care (UC)

ACTIVE COMPARATOR

196 African American smokers will receive 12 weeks of smoking cessation counseling and 18 weeks of nicotine patch.

Drug: Nicotine patch

Optimized Care (OPT)

EXPERIMENTAL

196 African American smokers will receive 12 weeks of smoking cessation counseling. They will receive the nicotine patch and up to two pharmacotherapy adaptations (VAR, BUP+NP) based on verified smoking status at Weeks 2 and 6 for a total of 18 weeks of pharmacotherapy.

Drug: Nicotine patch; Drug: Varenicline Tartrate; Drug: Bupropion

Interventions

Nicotine patch DRUG

Participants will receive the 24-hour 21mg nicotine patch for up to 18 weeks of treatment.

Also known as: Nicoderm

Optimized Care (OPT); Usual Care (UC)

Varenicline Tartrate DRUG

VAR will be dispensed 0.5 mg once daily on Days 1-3, 0.5 mg twice daily on Days 4-7, and 1 mg twice daily from Day 8 through the end of treatment.

Also known as: Chantix

Optimized Care (OPT)

Bupropion DRUG

BUP will be dispensed 150 mg once daily on Days 0-3 and then 150 mg twice daily from Day 4 through optimization or the end of treatment.

Also known as: Zyban, Wellbutrin

Optimized Care (OPT)

Eligibility Criteria

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

You may qualify if:

• Non-Hispanic African American
• ≥ 18 years of age
• Smoke 5-30 cigarettes per day (CPD)
• Daily cigarette smoker
• Smoked at current rate for \> 6 months
• Verified smoker (CO \> 5 ppm)
• Functioning telephone
• Interested in quitting smoking
• Willing to take NP, VAR , and/or BUP+NP for 18 weeks and complete all study visits

You may not qualify if:

• Use of non-cigarette tobacco products in past 30 days
• Medical contraindications to NP, BUP, or VAR: unstable cardiac condition (e.g., unstable angina or AMI) cardiac event, or stroke in the past 4 weeks; renal impairment; medications contraindicated ; history of clinically significant allergic reactions; history of epilepsy, seizure, head trauma, psychosis, bipolar disorder, eating disorder; unstable panic disorder or depression; active suicidal ideation; treatment for alcohol or drug dependence in the past year
• Use of pharmacotherapy in the month prior to enrollment
• Pregnant, contemplating getting pregnant, or breastfeeding
• Unstable housing (e.g., street, shelter)
• Plans to move from Kansas City during the treatment and follow-up phase
• Another household member enrolled in the study

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Swope Health Central

Kansas City, Missouri, 64130, United States

Location

Related Publications (3)

• Lambart LM, Cox LS, Mayo MS, Brown AR, Leavens ELS, Ahluwalia JS, Nollen NL. Change in Cigarette, Other Tobacco Product, and Cannabis Use Among Individuals Who Used or Did Not Use Cannabis During a Smoking Cessation Trial. Nicotine Tob Res. 2025 Aug 22;27(9):1641-1646. doi: 10.1093/ntr/ntaf045.

  PMID: 39976595 DERIVED

• Nollen NL, Ahluwalia JS, Mayo MS, Ellerbeck EF, Leavens ELS, Salzman G, Shanks D, Woodward J, Greiner KA, Cox LS. Multiple Pharmacotherapy Adaptations for Smoking Cessation Based on Treatment Response in Black Adults Who Smoke: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2317895. doi: 10.1001/jamanetworkopen.2023.17895.

  PMID: 37338906 DERIVED

• Nollen NL, Cox LS, Mayo MS, Ellerbeck EF, Arnold MJ, Salzman G, Shanks D, Woodward J, Greiner KA, Ahluwalia JS. Protocol from a randomized clinical trial of multiple pharmacotherapy adaptations based on treatment response in African Americans who smoke. Contemp Clin Trials Commun. 2022 Nov 5;30:101032. doi: 10.1016/j.conctc.2022.101032. eCollection 2022 Dec.

  PMID: 36387983 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Tobacco Use Cessation Devices; Nicotine; Varenicline; Bupropion

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Quinoxalines; Propiophenones; Ketones; Organic Chemicals

Results Point of Contact

• Title: Dr. Nicole Nollen
• Organization: University of Kanas Medical Center

nnollen@kumc.edu

913-588-3784

Study Officials

• Nicole 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 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: African American smokers randomized to OPT (n=196) will receive high intensity smoking cessation counseling, nicotine patch (NP), and up to two pharmacotherapy optimizations \[varenicline (VAR), bupropion (BUP) plus NP\] based on verified smoking status at Weeks 2 and 6. African American smokers randomized to enhanced UC (n=196) will receive the same high intensity counseling and NP with no optimizations in pharmacotherapy.

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: April 1, 2019
• Study Start: May 1, 2019
• Primary Completion: November 30, 2021
• Study Completion: January 30, 2022
• Last Updated: April 3, 2023
• Results First Posted: April 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)