Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
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.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Usual Care (UC)
196 African American smokers will receive 12 weeks of smoking cessation counseling and 18 weeks of nicotine patch.
  • Drug: Nicotine patch
    Participants will receive the 24-hour 21mg nicotine patch for up to 18 weeks of treatment.
    Other names:
    • Nicoderm
Experimental
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.
  • Drug: Nicotine patch
    Participants will receive the 24-hour 21mg nicotine patch for up to 18 weeks of treatment.
    Other names:
    • Nicoderm
  • 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.
    Other names:
    • Chantix
  • 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.
    Other names:
    • Zyban
    • Wellbutrin

Recruiting Locations

Swope Health Central
Kansas City, Missouri 64130
Contact:
Tricia Snow
816-599-5311
psnow@kumc.edu

More Details

Status
Recruiting
Sponsor
University of Kansas Medical Center

Study Contact

Tricia Snow
816-599-5311
psnow@kumc.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.