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

NCT01078298 | Completed Phase 4 Results DMC

• 1 other identifier: A3051122
• Study Type: interventional
• Target: 525
• Locations: 8 countries
• Sites: 41

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.

Conditions

Smoking Cessation; Depression

Keywords

smoking; smoking cessation; smoking cessation in depressed subjects

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With a Four-Week Continuous Quit Rate (CQR)

  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).

  Week 9 through Week 12

Secondary Outcomes (3)

• Percentage of Participants With Continuous Abstinence Rate (CAR)

  Week 9 through Week 24, Week 9 through Week 52

• Number of Participants With 7-day Point Prevalence (PP) of Abstinence

  Weeks 12, 24, 52

• Number of Participants With 4-Week Point Prevalence (PP) of Abstinence

  Week 52

Other Outcomes (7)

• Number of Participants With Adverse Events (Including Solicited Neuropsychiatric Adverse Events)

  Baseline up to Week 16

• Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)

  Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16, 24, 32, 40, 52

• Number of Participants With Clinical Global Impression - Severity (CGI-S) Score

  Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16, 24, 32, 40, 52

Study Arms (2)

varenicline

EXPERIMENTAL

Drug: varenicline

placebo

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

varenicline DRUG

varenicline tablets titrated to 1 mg BID during 1st week and then 1 mg BID for 11 weeks

Also known as: Champix/Chantix

varenicline

placebo DRUG

placebo tablets matched in appearance and dosage to varenicline tablets

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (41)

Collaborative Neuroscience Network, Inc.

Garden Grove, California, 92845, United States

Location

California Neuroscience Research Medical Group, Inc

Sherman Oaks, California, 91403, United States

Location

Behavioral Health and Wellness Program, University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Comprehensive Psychiatric Care

Norwich, Connecticut, 06360, United States

Location

Emerald Coast Mood & Memory, PA

Fort Walton Beach, Florida, 32547, United States

Location

Clinical Neuroscience Solutions Incorporated

Jacksonville, Florida, 32216, United States

Location

Clinical Neuroscience Solutions Incorporated

Orlando, Florida, 32806, United States

Location

Vince and Associates Clinical Research

Overland Park, Kansas, 66212, United States

Location

Vince and Associates Clinical Research

Overland, Kansas, 66211, United States

Location

Heartland Research Associates, LLC

Wichita, Kansas, 67207, United States

Location

NorthCoast Clinical Trials Inc.

Beachwood, Ohio, 44122, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45237, United States

Location

CRI Worldwide LLC

Philadelphia, Pennsylvania, 19139, United States

Location

Clinical Trials of Memphis

Bartlett, Tennessee, 38134, United States

Location

FutureSearch Trials

Austin, Texas, 78731, United States

Location

Claghorn-Lesem Research Clinic, Ltd.

Houston, Texas, 77008, United States

Location

Psychiatric Clinic, Clinical Center Banja Luka

Banja Luka, 78000, Bosnia and Herzegovina

Location

Clinic of Psychiatry, Clinical Center University of Sarajevo

Sarajevo, 71000, Bosnia and Herzegovina

Location

"Poliklinika Neuron" - Croatian Institute for Brain Research

Zagreb, 10000, Croatia

Location

Psychiatric Hospital Vrapce

Zagreb, 10000, Croatia

Location

Universitaetsklinikum Freiburg

Freiburg im Breisgau, 79104, Germany

Location

Ludwig Maximilians-Universitaet Muenchen

München, 80336, Germany

Location

Universitaetsklinik Tuebingen, Klinik fuer Psychiatrie und Psychotherapie

Tübingen, 72076, Germany

Location

Fovarosi Onkormanyzat Nyiro Gyula Korhaz, II. Pszichiatriai Osztaly

Budapest, 1135, Hungary

Location

Processus Kft., Varoskapu Rendelo

Budapest, 1137, Hungary

Location

Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza, Pszichiatriai Osztaly

Gyula, 5700, Hungary

Location

Varosi Egeszsegugyi Kozpont

Kunszentmárton, 5440, Hungary

Location

Donatella 99 Bt.

Szentes, 6600, Hungary

Location

Fejer Megyei Szent Gyorgy Korhaz, Pszichiatriai Osztaly

Székesfehérvár, 8000, Hungary

Location

Spitalul Clinic de Psihiatrie Socola, sectia VII

Iași, Iaşi, 700282, Romania

Location

Spitalul Psihiatrie "Prof. Dr. Al. Obregia"

Bucharest, Sector 4, Romania

Location

Spitalul Clinic de Psihiatrie Prof. Dr. Al. Obregia, sectia 2

Bucharest, 041902, Romania

Location

Federal State Institution Moscow Scientific Research Institute of Psychiatry of Roszdrav

Moscow, 107076, Russia

Location

Institution of Russian Academy of Medical Sciences Mental Health Research Center

Moscow, 115522, Russia

Location

Moscow State Healthcare Institution Clinical Mental Hospital No 12

Moscow, 125367, Russia

Location

St-Petersburg State Healthcare Institution St. Nicholas Mental Hospital

Saint Petersburg, 190121, Russia

Location

Hospital de La Santa Creu I Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

Hospital General de La Vall D'Hebron

Barcelona, Barcelona, 08035, Spain

Location

Centro de Salud Mental Ii "La Corredoria"

Oviedo, Principality of Asturias, 33011, Spain

Location

Centro de Salud Torrero La Paz

Zaragoza, Zaragoza, 50007, Spain

Location

Related Publications (2)

• Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

  PMID: 37142273 DERIVED

• Anthenelli RM, Morris C, Ramey TS, Dubrava SJ, Tsilkos K, Russ C, Yunis C. Effects of varenicline on smoking cessation in adults with stably treated current or past major depression: a randomized trial. Ann Intern Med. 2013 Sep 17;159(6):390-400. doi: 10.7326/0003-4819-159-6-201309170-00005.

  PMID: 24042367 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Smoking Cessation; Depression; Smoking

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2010
• First Posted: March 2, 2010
• Study Start: March 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: April 16, 2013
• Results First Posted: April 16, 2013

Record last verified: 2013-03

Locations

RU (4); CR (2); RO (3); US (17); ES (4); DE (3); HU (6); BO (2)