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

NCT01078298

Last updated date
Study Location
Collaborative Neuroscience Network, Inc.
Garden Grove, California, 92845, United States
Contact
1-800-718-1021

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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.

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Smoking Cessation, DepressionSafety And Efficacy Of 12 Weeks Of Varenicline For Smoking Cessation In Smokers With Depression NCT01078298
  1. Garden Grove, California
  2. Sherman Oaks, California
  3. Aurora, Colorado
  4. Norwich, Connecticut
  5. Fort Walton Beach, Florida
  6. Jacksonville, Florida
  7. Orlando, Florida
  8. Overland Park, Kansas
  9. Overland, Kansas
  10. Wichita, Kansas
  11. Beachwood, Ohio
  12. Cincinnati, Ohio
  13. Cincinnati, Ohio
  14. Philadelphia, Pennsylvania
  15. Bartlett, Tennessee
  16. Austin, Texas
  17. Houston, Texas
  18. Banja Luka,
  19. Sarajevo,
  20. Zagreb,
  21. Zagreb,
  22. Freiburg,
  23. Muenchen,
  24. Tuebingen,
  25. Budapest,
  26. Budapest,
  27. Gyula,
  28. Kunszentmarton,
  29. Szekesfehervar,
  30. Szentes,
  31. Bucuresti, Sector 4
  32. Bucuresti,
  33. Iasi,
  34. Moscow,
  35. Moscow,
  36. Moscow,
  37. St-Petersburg,
  38. Oviedo, Asturias
  39. Barcelona,
  40. Barcelona,
  41. Zaragoza,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Safety And Efficacy Of 12 Weeks Of Varenicline For Smoking Cessation In Smokers With Depression
Official Title  ICMJE 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 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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Smoking Cessation
  • Depression
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: varenicline
    Intervention: Drug: varenicline
  • Placebo Comparator: placebo
    placebo
    Intervention: Drug: placebo
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2012)
525
Original Estimated Enrollment  ICMJE
 (submitted: February 26, 2010)
500
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bosnia and Herzegovina,   Croatia,   Germany,   Hungary,   Romania,   Russian Federation,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01078298
Other Study ID Numbers  ICMJE A3051122
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP