CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 392 enrolled
Drug / intervention
Nicotine patch +2 moredrug
Likely dose
Nicotine patch 21mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03897439
NCT03897439Phase 3Completed

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

University of Kansas Medical Center·interventional·Posted Apr 1, 2019·Updated Apr 3, 2023

In Brief

A Phase 3 clinical trial evaluating Nicotine patch, Varenicline Tartrate, and 1 other intervention for Smoking Cessation. Completed, enrolled 392 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedApr 1, 2019
Enrollment StartMay 1, 2019
Primary CompletionNov 30, 2021
Study CompletionJan 30, 2022
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 7.3 years ago

Interventions

Nicotine patchdrug

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

Varenicline Tartratedrug

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

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.