Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Factorial Assignment

Study Primary Completion Date: August 2009

Intervention(s) in this Clinical Trial

• 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).
• 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).
• Drug: Placebo
  • Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: varenicline
  • varenicline 2mg/day
• Experimental: Bupropion
  • Bupropion 300mg/day
• Placebo Comparator: Placebo
  • Placebo Control

Primary Measures

• latency to initiate ad-lib smoking session
  • Time Frame: in the laboratory session
    Safety Issue?: No

Secondary Measures

• number of cigarettes smoked during the ad-lib period
  • Time Frame: during the laboratory session
    Safety Issue?: No

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 DSM-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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Yale University

Overall Clinical Trial Officials and Contacts

Sherry A McKee, PhD Principal Investigator Yale University  

Overall Contact: Sabrina Coppola 203-737-2827 

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00580853

Study ID Number: HIC0702002390

ClinicalTrials.gov Identifier: NCT00580853

Health Authority: United States: Institutional Review Board