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

Phase 4

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Male or female cigarette smokers, 18-75 years, motivated to stop smoking and considered suitable for a smoking cessation attempt
Smoked an average of at least 10 cigarettes per day during past year and over past month, and exhaled carbon monoxide (CO) > 10 ppm at screening
Current or past diagnosis of MDD without psychotic features, either single or recurrent, using DSM IV TR based on clinical assessment and confirmed by SCID and at least one of the following:
On stable antidepressant treatment for MDD (stable dose for at least 2 months)
Major depressive episode, using DSM IV TR, in the past 2 years successfully treated

Exclusion Criteria

Current or past diagnosis of dementia, schizophrenia, schizoaffective disorder, or other psychotic disorder, bipolar I disorder, bipolar II disorder.
Subjects with antisocial, schizotypal, or any other personality disorder severe enough to compromise the subject's ability to comply with the study requirements..
Current use of either bupropion or nortryptiline.

Arm && Interventions

Group	Intervention	Description
varenicline	varenicline	-
placebo	placebo	placebo

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With a Four-Week Continuous Quit Rate (CQR)	Week 9 through Week 12	Percentage of participants who reported no use of nicotine-containing products by answering "No" to the nicotine use inventory (NUI) questions: 'Has the participant smoked cigarettes' and 'Has the participant used other nicotine-containing products' in the last 7 days (Week 9) or since last study visit (Week 9 through 12) confirmed by a measurement of an end-expiratory exhaled carbon monoxide (CO) measurement less than or equal to 10 parts per million (ppm).

Secondary Outcome Measures

Name	Time	Method
Number of Participants With 4-Week Point Prevalence (PP) of Abstinence	Week 52	Number of participants at Week 52 visit reporting no smoking and no use of other tobacco products in the last 4 weeks confirmed by a measurement of an end-expiratory exhaled CO measurement less than or equal to 10 ppm.
Percentage of Participants With Continuous Abstinence Rate (CAR)	Week 9 through Week 24, Week 9 through Week 52	Percentage of participants who remained abstinent from the period defined as start of the primary endpoint (Week 9) through Week 24 and the end of follow-up (Week 52) by reporting no use of nicotine-containing products confirmed by a measurement of an end-expiratory exhaled CO measurement less than or equal to 10 ppm.
Number of Participants With 7-day Point Prevalence (PP) of Abstinence	Weeks 12, 24, 52	Number of participants reporting no use of nicotine-containing products in the last 7 days confirmed by a measurement of an end-expiratory exhaled CO measurement less than or equal to 10 ppm.

Locations (38): Collaborative Neuroscience Network, Inc.
🇺🇸
Garden Grove, California, United States
California Neuroscience Research Medical Group, Inc
🇺🇸
Sherman Oaks, California, United States
Behavioral Health and Wellness Program, University of Colorado Denver
🇺🇸
Aurora, Colorado, United States
Comprehensive Psychiatric Care
🇺🇸
Norwich, Connecticut, United States
Emerald Coast Mood & Memory, PA
🇺🇸
Fort Walton Beach, Florida, United States
Clinical Neuroscience Solutions Incorporated
🇺🇸
Orlando, Florida, United States
Vince and Associates Clinical Research
🇺🇸
Overland, Kansas, United States
Heartland Research Associates, LLC
🇺🇸
Wichita, Kansas, United States
NorthCoast Clinical Trials Inc.
🇺🇸
Beachwood, Ohio, United States
University of Cincinnati
🇺🇸
Cincinnati, Ohio, United States
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Collaborative Neuroscience Network, Inc.
🇺🇸Garden Grove, California, United States