Safety And Efficacy Of 12 Weeks Of Varenicline For Smoking Cessation In Smokers With Depression
- Registration Number
- NCT01078298
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 525
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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.
Trial Locations
- Locations (38)
Comprehensive Psychiatric Care
🇺🇸Norwich, Connecticut, United States
Clinical Neuroscience Solutions Incorporated
🇺🇸Orlando, Florida, United States
Ludwig Maximilians-Universitaet Muenchen
🇩🇪Muenchen, Germany
"Poliklinika Neuron" - Croatian Institute for Brain Research
🇭🇷Zagreb, Croatia
Universitaetsklinik Tuebingen, Klinik fuer Psychiatrie und Psychotherapie
🇩🇪Tuebingen, Germany
Spitalul Psihiatrie "Prof. Dr. Al. Obregia"
🇷🇴Bucuresti, Sector 4, Romania
Moscow State Healthcare Institution Clinical Mental Hospital No 12
🇷🇺Moscow, Russian Federation
Clinical Trials of Memphis
🇺🇸Bartlett, Tennessee, United States
Claghorn-Lesem Research Clinic, Ltd.
🇺🇸Houston, Texas, United States
Centro de Salud Mental Ii "La Corredoria"
🇪🇸Oviedo, Asturias, Spain
Vince and Associates Clinical Research
🇺🇸Overland, Kansas, United States
Heartland Research Associates, LLC
🇺🇸Wichita, Kansas, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza, Pszichiatriai Osztaly
🇭🇺Gyula, Hungary
Collaborative Neuroscience Network, Inc.
🇺🇸Garden Grove, California, United States
Emerald Coast Mood & Memory, PA
🇺🇸Fort Walton Beach, Florida, United States
NorthCoast Clinical Trials Inc.
🇺🇸Beachwood, Ohio, United States
CRI Worldwide LLC
🇺🇸Philadelphia, Pennsylvania, United States
Psychiatric Clinic, Clinical Center Banja Luka
🇧🇦Banja Luka, Bosnia and Herzegovina
FutureSearch Trials
🇺🇸Austin, Texas, United States
Clinic of Psychiatry, Clinical Center University of Sarajevo
🇧🇦Sarajevo, Bosnia and Herzegovina
Universitaetsklinikum Freiburg
🇩🇪Freiburg, Germany
Psychiatric Hospital Vrapce
🇭🇷Zagreb, Croatia
Processus Kft., Varoskapu Rendelo
🇭🇺Budapest, Hungary
Donatella 99 Bt.
🇭🇺Szentes, Hungary
Fejer Megyei Szent Gyorgy Korhaz, Pszichiatriai Osztaly
🇭🇺Szekesfehervar, Hungary
Spitalul Clinic de Psihiatrie Prof. Dr. Al. Obregia, sectia 2
🇷🇴Bucuresti, Romania
Federal State Institution Moscow Scientific Research Institute of Psychiatry of Roszdrav
🇷🇺Moscow, Russian Federation
Spitalul Clinic de Psihiatrie Socola, sectia VII
🇷🇴Iasi, Romania
Institution of Russian Academy of Medical Sciences Mental Health Research Center
🇷🇺Moscow, Russian Federation
Hospital de La Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
St-Petersburg State Healthcare Institution St. Nicholas Mental Hospital
🇷🇺St-Petersburg, Russian Federation
Hospital General de La Vall D'Hebron
🇪🇸Barcelona, Spain
Centro de Salud Torrero La Paz
🇪🇸Zaragoza, Spain
Behavioral Health and Wellness Program, University of Colorado Denver
🇺🇸Aurora, Colorado, United States
California Neuroscience Research Medical Group, Inc
🇺🇸Sherman Oaks, California, United States
Fovarosi Onkormanyzat Nyiro Gyula Korhaz, II. Pszichiatriai Osztaly
🇭🇺Budapest, Hungary
Varosi Egeszsegugyi Kozpont
🇭🇺Kunszentmarton, Hungary