CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 122 enrolled
Drug / intervention
Chantix +3 moredrug
Likely dose
Chantix 0.5 mgfrom 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/NCT02859142
NCT02859142Phase 4Completed

Varenicline Augmentation of Patch Outcomes in Heavy Drinkers' Smoking Cessation

University of Chicago·interventional·Posted Aug 8, 2016·Updated Sep 27, 2021

In Brief

A Phase 4 clinical trial evaluating Chantix, Behavioral Counseling Sessions, and 2 other interventions for Smoking Cessation and Alcohol Drinking. Completed, enrolled 122 participants across 1 site.

Detailed Summary

The purpose of this study is to learn if the combination of a study drug and patch is more effective in helping heavy drinkers stop smoking than just the patch alone The study drug, varenicline, has been approved by the Food and Drug Administration (FDA) to help people stop smoking, but it is not known if the addition of varenicline to standard smoking cessation treatment with nicotine patches will help people stop smoking who are regular, frequent drinkers. This study is being done because cigarette smoking is the number one preventable cause of death and disease in the United States.

Study Details

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

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 8, 2016
Enrollment StartMar 29, 2018
Primary CompletionSep 30, 2020
Study CompletionOct 15, 2020
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 9.9 years ago

Interventions

Chantixdrug

Chantix given alongside standard smoking cessation treatment, and administered per manufacturer's instructions \[0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then one 1.0 mg tablet twice per day\]

Behavioral Counseling Sessionsbehavioral

One-to-one behavioral counseling sessions with a trained therapist

NicodermCQdrug

Nicotine patches provided over 12 week participation

Placebodrug

Identical in appearance to varenicline \[0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then one 1.0 mg tablet twice per day\]