Measuring Smoking Behaviors While Using Varenicline

NCT00948155

Last updated date
Study Location
Tobacco Use Research Center
Philadelphia, Pennsylvania, 19104, 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.
Nicotine Dependence
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- self report minimum 10 daily cigarettes

- self report smoking every day past 5 years

- between the ages 21-65

- self report intention to try to quit smoking in the next 6 months

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


- self reported use of any nicotine-containing products other than non-menthol
cigarettes


- self reported history or current treatment of substance abuse (other than nicotine
dependence)


- self reported alcohol use greater than 25 standard drinks per week;


- currently pregnant, planned pregnancy or lactating (females: negative urine pregnancy
screen)


- self reported history or current diagnosis of any Axis 1 disorders except past
depression


- self reported serious or unstable disease within past year


- self reported history of epilepsy or seizure disorder;


- self reported history or current diagnosis of COPD (chronic obstructive pulmonary
disease), cardiovascular disease, heart attack, or uncontrolled hypertension


- self reported kidney function impairment


- any current or recent (30 day) use of: smoking cessation medications, anti-psychotics,
anti-depressants, anti-anxiety, panic medications, stimulants or opiate-containing
medications


- less than 5 years of daily smoking


- any medical condition or concomitant medication that could compromise participant
safety or treatment


- provide a baseline carbon monoxide (CO) reading < 10 ppm


- self reported use of non filtered cigarettes


- inability to provide informed consent or complete any of the study tasks as determined
by the Principal Investigator and/or Study Physician

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Advanced Information
Descriptive Information
Brief Title  ICMJE Measuring Smoking Behaviors While Using Varenicline
Official Title  ICMJE Assessment of Smoking Topography and Behaviors During Response to Varenicline
Brief Summary This study will demonstrate the behavioral responses to varenicline, helping to better understand its mechanisms. Hypotheses for the study are to observe decreases in smoking topography and nicotine cigarette choice on varenicline, relative to placebo; and decreases on day 21 relative to day 7 during varenicline treatment. We also propose to examine if extended duration of treatment has clinical significance in decreasing smoking behaviors, thus increasing the efficacy of varenicline.
Detailed Description This study is designed to examine the behavioral responses a cigarette smoker may have to using varenicline. Behavioral responses may help to better understand its mechanisms which in turn could improve treatment outcomes. The primary hypothesis for the study is to observe decreases in smoking topography, an objective measure of smoking behavior or puffing, on varenicline, relative to placebo; and decreases on day 21 relative to day 7 during varenicline treatment. We will also examine puffing and nicotine cigarette choices during lab visits at baseline, and Days 7 and 21. We also propose to examine if extended duration of treatment has clinical significance in decreasing smoking behaviors, thus potentially increasing the efficacy of varenicline.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Nicotine Dependence
Intervention  ICMJE Drug: Varenicline
Intervention Drug (Varenicline (Chantix) will be administered in standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21.
Other Name: Chantix
Study Arms  ICMJE
  • Experimental: Varenicline before placebo

    Drug (Varenicline (Chantix)): Placebo

    Intervention to be administered is: participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.

    Intervention: Drug: Varenicline
  • Experimental: Placebo then Varenicline

    Placebo: Drug Varenicline (Chantix)

    Intervention to be administered is: participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.

    Intervention 'Drug (Varenicline (Chantix)): Placebo'

    Intervention: Drug: Varenicline
Publications * Ashare RL, Tang KZ, Mesaros AC, Blair IA, Leone F, Strasser AA. Effects of 21 days of varenicline versus placebo on smoking behaviors and urges among non-treatment seeking smokers. J Psychopharmacol. 2012 Oct;26(10):1383-90. doi: 10.1177/0269881112449397. Epub 2012 Jun 13.

*   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: December 15, 2014)
48
Original Estimated Enrollment  ICMJE
 (submitted: July 28, 2009)
30
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • self report minimum 10 daily cigarettes
  • self report smoking every day past 5 years
  • between the ages 21-65
  • self report intention to try to quit smoking in the next 6 months

Exclusion Criteria:

  • self reported use of any nicotine-containing products other than non-menthol cigarettes
  • self reported history or current treatment of substance abuse (other than nicotine dependence)
  • self reported alcohol use greater than 25 standard drinks per week;
  • currently pregnant, planned pregnancy or lactating (females: negative urine pregnancy screen)
  • self reported history or current diagnosis of any Axis 1 disorders except past depression
  • self reported serious or unstable disease within past year
  • self reported history of epilepsy or seizure disorder;
  • self reported history or current diagnosis of COPD (chronic obstructive pulmonary disease), cardiovascular disease, heart attack, or uncontrolled hypertension
  • self reported kidney function impairment
  • any current or recent (30 day) use of: smoking cessation medications, anti-psychotics, anti-depressants, anti-anxiety, panic medications, stimulants or opiate-containing medications
  • less than 5 years of daily smoking
  • any medical condition or concomitant medication that could compromise participant safety or treatment
  • provide a baseline carbon monoxide (CO) reading < 10 ppm
  • self reported use of non filtered cigarettes
  • inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator and/or Study Physician
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT00948155
Other Study ID Numbers  ICMJE 808930
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andrew Strasser, University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Andrew Strasser, PhDUniversity of Pennsylvania
PRS Account University of Pennsylvania
Verification Date December 2014

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