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Individualizing Pharmacotherapy for African American Smokers

NCT03897439 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 392

Last updated 2023-04-03

Study results available
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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

Interventions

DRUG

Nicotine patch

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

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.

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.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • University of Kansas Medical Center

    lead OTHER

Principal Investigators

  • Nicole Nollen, PhD · University of Kansas Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2021-11-30
Completion
2022-01-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03897439 on ClinicalTrials.gov