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The Effect of Varenicline (Chantix) and Bupropion (Zyban) on Smoking Lapse Behavior

This study has been completed.
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Sherry McKee, Yale University
ClinicalTrials.gov Identifier:
NCT00580853
First received: December 25, 2007
Last updated: January 20, 2017
Last verified: January 2017
December 25, 2007
January 20, 2017
April 2007
October 2016   (Final data collection date for primary outcome measure)
Latency to Initiate Ad-lib Smoking Session [ Time Frame: 0 to 50 minutes ]
minutes to start smoking (range 0 to 50 minutes)
Latency to Initiate Ad-lib Smoking Session [ Time Frame: in the laboratory session ]
Complete list of historical versions of study NCT00580853 on ClinicalTrials.gov Archive Site
Number of Cigarettes Smoked During the 60 Minute Ad-lib Period [ Time Frame: 60 minutes ]
number of cigarettes smoked (range 0-8) during the 60 minute ad-lib period
number of cigarettes smoked during the ad-lib period [ Time Frame: during the laboratory session ]
Not Provided
Not Provided
 
The Effect of Varenicline (Chantix) and Bupropion (Zyban) on Smoking Lapse Behavior
The Effect of Varenicline (Chantix) and Bupropion (Zyban) on Smoking Lapse Behavior
The purpose of this study is to examine how smoking cessation medications (varenicline, bupropion) affect the ability to resist smoking and also subsequent ad-lib smoking in non-treatment seeking daily smokers.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Smoking Lapse Behavior
  • Drug: varenicline
    2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8).
    Other Name: Chantix
  • Drug: bupropion
    300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8).
    Other Name: Zyban
  • Drug: Placebo
    Placebo
  • Experimental: varenicline
    varenicline 2mg/day
    Intervention: Drug: varenicline
  • Experimental: Bupropion
    Bupropion 300mg/day
    Intervention: Drug: bupropion
  • Placebo Comparator: Placebo
    Placebo Control
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
October 2016
October 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • ages 18-55
  • able to read and write in English
  • Smokers

Exclusion Criteria:

  • any significant current medical or psychiatric conditions that would contraindicate smoking
  • current Diagnostic and Statistical Manual IV abuse or dependence of other substances, other than nicotine dependence or alcohol abuse
  • positive test result at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines
  • women who are pregnant or nursing
  • suicidal, homicidal, or evidence of current severe mental illness
  • participants prescribed any psychotropic drug in the 30 days prior to study enrollment
  • blood donation within the past 6 weeks
  • individuals seeking treatment for smoking cessation or have attempted to quit smoking within the past 3 months
  • specific exclusions for bupropion administration not already specified, including: have taken monoamine inhibitors in the past 6 weeks; history of anorexia or bulimia; previous hypersensitivity to bupropion; history of alcohol or drug dependence in the past year; history of seizure disorder of any etiology
  • known allergy to varenicline or taking H2blockers
  • participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current study
Sexes Eligible for Study: All
21 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00580853
HIC0702002390
P50AA015632 ( US NIH Grant/Contract Award Number )
Yes
Not Provided
No
Not Provided
Sherry McKee, Yale University
Yale University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Sherry A McKee, PhD Yale University
Yale University
January 2017

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