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Smoking CessationPhase 3NCT03897439

Individualizing Pharmacotherapy for African American Smokers

A Phase 3 study testing Nicotine patch, Varenicline Tartrate and Bupropion in people with Smoking Cessation, run by University of Kansas Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Smoking Cessation
What is being tested?
Nicotine patch, Varenicline Tartrate and Bupropion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
392 participants
Where
1 siteUnited States
Study dates
1 May 2019to 30 Jan 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 9Show fewer
  • Functioning telephone
  • Interested in quitting smoking
  • Willing to take NP, VAR , and/or BUP+NP for 18 weeks and complete all study visits

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Swope Health Central

    Kansas City, Missouri, 64130

Other trials in United States

About this study

Official title: Individualizing Pharmacotherapy: A Novel Optimization Strategy to Increase Smoking Cessation in the African American Community

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.

Read the 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.

Being tested
Nicotine patch, Varenicline Tartrate, Bupropion
Medical subject headings
Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nicotine patchDrug

    Also called Nicoderm

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

  • Varenicline TartrateDrug

    Also called Chantix

    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.

  • BupropionDrug

    Also called Zyban, Wellbutrin

    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.

Study groups in NCT03897439
Study groupRoleWhat they receive
Usual Care (UC)Active comparator196 African American smokers will receive 12 weeks of smoking cessation counseling and 18 weeks of nicotine patch.
Receives: Drug: Nicotine patch
Optimized Care (OPT)Experimental196 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.
Receives: Drug: Nicotine patch; Drug: Varenicline Tartrate; Drug: Bupropion

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 12

Secondary outcomes (2)

  1. Number of Participants With Biochemically Verified Smoking Abstinence at 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

    Measured: Week 18

  2. Number of Participants With Biochemically Verified Smoking Abstinence at 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

    Measured: Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2019
  2. Study start1 May 2019
  3. Primary completion30 Nov 2021
  4. Study completion30 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
392 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03897439
Sponsor's protocol ID
Study0000142310
Other IDs
R01DA046576
Status last verified
Mar 2023
First submitted
25 Mar 2019
Last updated
3 Apr 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39976595

  • 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.

    PubMed 37338906

  • 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.

    PubMed 36387983

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nicotine patch, Varenicline Tartrate and Bupropion in people with Smoking Cessation, run by University of Kansas Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Biochemically Verified Smoking Abstinence at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03897439, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.

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