Safety And Efficacy Of 12 Weeks Of Varenicline For Smoking Cessation In Smokers With Depression
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.
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
- Enrollment
- 525 participants
Conditions and interventions
Conditions
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.