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Individualizing Pharmacotherapy for African American Smokers

Sponsor
University of Kansas Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03897439
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
392
Enrollment
1
Location
2
Arms
33
Actual Duration (Months)
11.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
392 participants
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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Individualizing Pharmacotherapy: A Novel Optimization Strategy to Increase Smoking Cessation in the African American Community
Actual Study Start Date :
May 1, 2019
Actual Primary Completion Date :
Nov 30, 2021
Actual Study Completion Date :
Jan 30, 2022

Arms and Interventions

Arm Intervention/Treatment
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Biochemically verified smoking abstinence [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.

    Secondary Outcome Measures

    1. Biochemically verified smoking abstinence [Week 18]

      Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 18 visit. This will evaluate the end-of-treatment efficacy of optimized pharmacotherapy for smoking cessation in African American smokers

    2. Biochemically verified smoking abstinence [Week 26]

      Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 26 visit. This will evaluate the long-term efficacy of optimized pharmacotherapy for smoking cessation in African American smokers

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Swope Health Central Kansas City Missouri United States 64130

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Nicole Nollen, PhD, University of Kansas Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nikki Nollen, PhD, MA, Associate Professor, University of Kansas Medical Center
    ClinicalTrials.gov Identifier:
    NCT03897439
    Other Study ID Numbers:
    • Study0000142310
    • R01DA046576
    First Posted:
    Apr 1, 2019
    Last Update Posted:
    Mar 10, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Bupropion
    Nicotine
    Varenicline

    Study Results

    No Results Posted as of Mar 10, 2022