Assessing Neuropsychiatric Symptoms Including Depression, Anxiety, Irritability, and Suicidal Thoughts or Behavior in Subjects Quitting Smoking on Varenicline Tartrate or Placebo

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NCT00749944

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Study Location
Pfizer Investigational Site
Austin, Texas, 78759, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Smoking Cessation
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

- smokers who smoke >10 cigarettes/day and who have at least a moderate level of addiction as measured by the Fagerstrom Test for Nicotine Dependence (score >5)

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


- Any neuropsychiatric disease including depression, history of suicidal thoughts or
behavior, bipolar disorder.


- Any unstable medical condition

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Advanced Information
Descriptive Information
Brief Title  ICMJE Assessing Neuropsychiatric Symptoms Including Depression, Anxiety, Irritability, and Suicidal Thoughts or Behavior in Subjects Quitting Smoking on Varenicline Tartrate or Placebo
Official Title  ICMJE An Experimental Medicine, Randomized, Double-Blind Study Assessing Neuropsychiatric Symptoms In Quitting Smokers Treated With Varenicline Tartrate Or Placebo
Brief Summary Study objective is to compare neuropsychiatric adverse events in subjects treated with varenicline or placebo in a controlled setting where both groups are experiencing nicotine withdrawal.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Smoking Cessation
Intervention  ICMJE
  • Drug: varenicline
    1 mg tablets twice daily by mouth (after one week of uptitration: 0.5mg once daily for three days, 0.5mg twice daily for four days)
    Other Name: Chantix, Champix
  • Drug: placebo
    1 mg tablets twice daily by mouth (after one week of uptitration: 0.5mg once daily for three days, 0.5mg twice daily for four days)
Study Arms  ICMJE
  • Experimental: varenicline
    Intervention: Drug: varenicline
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
Publications * Garza D, Murphy M, Tseng LJ, Riordan HJ, Chatterjee A. A double-blind randomized placebo-controlled pilot study of neuropsychiatric adverse events in abstinent smokers treated with varenicline or placebo. Biol Psychiatry. 2011 Jun 1;69(11):1075-82. doi: 10.1016/j.biopsych.2010.12.005. Epub 2011 Feb 3.

*   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: September 9, 2008)		110
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • smokers who smoke >10 cigarettes/day and who have at least a moderate level of addiction as measured by the Fagerstrom Test for Nicotine Dependence (score >5)

Exclusion Criteria:

  • Any neuropsychiatric disease including depression, history of suicidal thoughts or behavior, bipolar disorder.
  • Any unstable medical condition
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00749944
Other Study ID Numbers  ICMJE A3051115
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2010

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