CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,251 enrolled
Drug / intervention
Varenicline +3 moredrug
Likely dose
Varenicline 0.5mgfrom 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/NCT03176784
NCT03176784Phase 4Completed

UW Quitting Using Intensive Treatment Study

University of Wisconsin, Madison·interventional·Posted Jun 6, 2017·Updated Jan 23, 2023

In Brief

A Phase 4 clinical trial evaluating Varenicline, Nicotine patch, and 2 other interventions for Tobacco Dependence. Completed, enrolled 1,251 participants across 2 sites.

Detailed Summary

This research will determine whether two highly promising modifications to varenicline treatment (i.e. use of a nicotine patch adjuvant and extended 24-week duration) produce superior smoking outcomes when they are either used together or alone. Despite their promise, the proposed modifications have never been experimentally evaluated relative to standard varenicline pharmacotherapy. Thus, this innovative research will produce novel evidence regarding how best to help smokers quit, and thereby address the leading cause of preventable mortality and morbidity related to cardiovascular and pulmonary diseases.

Study Details

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

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedJun 6, 2017
Enrollment StartNov 11, 2017
Primary CompletionJul 9, 2020
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 9.1 years ago

Interventions

Vareniclinedrug

0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)

Nicotine patchdrug

14 mg and 7 mg nicotine patches used. See arms for specific durations.

Placebo Patchother

Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations.

Placebo Pillother

Placebo pills matched in appearance to the Active Varenicline pills in the Varenicline intervention. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)