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Varenicline and Combined NRT for Smoking Cessation

NCT02271919 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 631

Last updated 2026-04-24

Study results available
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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.

Conditions

  • Cigarette Smoker
  • Tobacco Use Disorder

Interventions

DRUG

Nicotine Lozenge

Given PO

DRUG

Nicotine Patch

Given via patch

OTHER

Placebo

Given PO or via patch

OTHER

Tobacco Cessation Counseling

Receive behavioral smoking cessation counseling

DRUG

Varenicline

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Jason Robinson · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-14
Primary Completion
2025-06-30
Completion
2026-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT02271919 on ClinicalTrials.gov