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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Collaborative Neuroscience Network, Inc.
Garden Grove, California, 92845 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Smoking Cessation, Depression
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01078298
Pfizer
Completed
Safety And Efficacy Of 12 Weeks Of Varenicline For Smoking Cessation In Smokers With Depression

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Safety And Efficacy Of 12 Weeks Of Varenicline For Smoking Cessation In Smokers With Depression
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
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Smoking Cessation
  • Depression
  • Drug: varenicline
    varenicline tablets titrated to 1 mg BID during 1st week and then 1 mg BID for 11 weeks
    Other Name: Champix/Chantix
  • Drug: placebo
    placebo tablets matched in appearance and dosage to varenicline tablets
  • Experimental: varenicline
    Intervention: Drug: varenicline
  • Placebo Comparator: placebo
    placebo
    Intervention: Drug: placebo
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. Erratum in: Ann Intern Med. 2013 Oct 15;159(8):576.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
525
June 2012
June 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Bosnia and Herzegovina,   Croatia,   Germany,   Hungary,   Romania,   Russian Federation,   Spain,   United States
 
 
NCT01078298
A3051122
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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