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Completed Phase 4 Interventional Results available

Safety And Efficacy Of 12 Weeks Of Varenicline For Smoking Cessation In Smokers With Depression

ClinicalTrials.gov ID: NCT01078298

Public ClinicalTrials.gov record NCT01078298. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 22, 2026, 11:28 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 4 12-week, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating The Safety And Efficacy Of Varenicline Tartrate (CP-526,555) 1mg BID For Smoking Cessation In Subjects With Depression

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Patients with depression tend to have a higher prevalence of smoking as well as increased severity of nicotine dependence. Phase 2 and Phase 3 varenicline clinical trials that demonstrated its efficacy and tolerability have not included subjects with depression. This smoking cessation study focuses on the depressed population and will assess the efficacy and safety of varenicline.

Study identification

NCT ID
NCT01078298
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Pfizer
Industry
Enrollment
525 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 28, 2010
Primary completion
May 31, 2012
Completion
May 31, 2012
Last update posted
Apr 15, 2013

2010 – 2012

United States locations

U.S. sites
17
U.S. states
9
U.S. cities
16
Facility City State ZIP Site status
Collaborative Neuroscience Network, Inc. Garden Grove California 92845
California Neuroscience Research Medical Group, Inc Sherman Oaks California 91403
Behavioral Health and Wellness Program, University of Colorado Denver Aurora Colorado 80045
Comprehensive Psychiatric Care Norwich Connecticut 06360
Emerald Coast Mood & Memory, PA Fort Walton Beach Florida 32547
Clinical Neuroscience Solutions Incorporated Jacksonville Florida 32216
Clinical Neuroscience Solutions Incorporated Orlando Florida 32806
Vince and Associates Clinical Research Overland Park Kansas 66212
Vince and Associates Clinical Research Overland Kansas 66211
Heartland Research Associates, LLC Wichita Kansas 67207
NorthCoast Clinical Trials Inc. Beachwood Ohio 44122
University of Cincinnati Cincinnati Ohio 45219
University of Cincinnati Cincinnati Ohio 45237
CRI Worldwide LLC Philadelphia Pennsylvania 19139
Clinical Trials of Memphis Bartlett Tennessee 38134
FutureSearch Trials Austin Texas 78731
Claghorn-Lesem Research Clinic, Ltd. Houston Texas 77008

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 24 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01078298, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 15, 2013 · Synced Sep 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01078298 live on ClinicalTrials.gov.

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