Individualizing Pharmacotherapy for African American Smokers

NCT ID: NCT03897439

Last Updated: 2023-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 392 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2022-01-30

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.

Detailed Description

The objective of this study is to examine the efficacy of optimized (OPT) versus enhanced usual care (UC) treatment for smoking cessation. 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. Pharmacotherapy and counseling in both groups will last for 18 weeks with long-term follow-up through Week 26. The primary outcome is biochemically-verified smoking status at Week 12.

Conditions

Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Usual Care (UC)

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

Group Type: ACTIVE_COMPARATOR

Nicotine patch

Intervention Type: DRUG

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

Optimized Care (OPT)

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.

Group Type: EXPERIMENTAL

Nicotine patch

Intervention Type: DRUG

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

Varenicline Tartrate

Intervention Type: 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.

Bupropion

Intervention Type: 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.

Interventions

Nicotine patch

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

Intervention Type: DRUG

Varenicline Tartrate

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.

Intervention Type: DRUG

Bupropion

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.

Intervention Type: DRUG

Other Intervention Names

Nicoderm; Chantix; Zyban; Wellbutrin

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Nikki Nollen, PhD, MA

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicole Nollen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

Swope Health Central

Kansas City, Missouri, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39976595 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37338906 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36387983 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R01DA046576

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Study0000142310

Identifier Type: -

Identifier Source: org_study_id