CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 631 enrolled
Drug / intervention
Nicotine Lozenge +4 moredrug
Likely dose
Not stated in 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/NCT02271919
NCT02271919Phase 4Completed
CompareCT.gov

Varenicline and Combined NRT for Initial Smoking Cessation and Rescue Treatment in Smokers: A Randomized Pilot Trial

M.D. Anderson Cancer Center·interventional·Posted Oct 22, 2014·Updated Apr 24, 2026

In Brief

A Phase 4 clinical trial evaluating Nicotine Lozenge, Nicotine Patch, and 3 other interventions for Cigarette Smoker and Tobacco Use Disorder. Completed, enrolled 631 participants across 1 site.

Detailed Summary

This randomized pilot phase IV trial studies the side effects and how well varenicline works compared to nicotine replacement therapy in helping patients that smoke to quit. Varenicline is a drug that acts the same way as nicotine in the brain but is not habit-forming. Nicotine replacement therapy consists of nicotine patches and lozenges. It is not yet known if varenicline is more effective than nicotine replacement therapy in helping patients quit smoking.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCigarette Smoker, Tobacco Use Disorder
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 22, 2014
Enrollment StartMay 14, 2015
Primary CompletionJun 30, 2025
Study CompletionApr 1, 2026
TodayJul 2, 2026
Enrollment to primary: 10.1 yearsPosted 11.7 years ago

Interventions

Nicotine Lozengedrug

Given PO

Nicotine Patchdrug

Given via patch

Placeboother

Given PO or via patch

Tobacco Cessation Counselingother

Receive behavioral smoking cessation counseling

Vareniclinedrug

Given PO