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

Tracking Information

First Received Date ^ICMJE

December 25, 2007

Last Updated Date

August 25, 2009

Start Date ^ICMJE

April 2007

Estimated Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

latency to initiate ad-lib smoking session [ Time Frame: in the laboratory session ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00580853 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

number of cigarettes smoked during the ad-lib period [ Time Frame: during the laboratory session ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Smoking Lapse Behavior

Intervention ^ICMJE

Drug: varenicline
Drug: bupropion
Drug: Placebo

Study Arms / Comparison Groups

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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2010

Estimated Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

21 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Sabrina Coppola

203-737-2827

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00580853

Responsible Party

Sherry McKee, Yale University School of Medicine

Study ID Numbers ^ICMJE

HIC0702002390, P50AA15632

Study Sponsor ^ICMJE

Yale University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Sherry A McKee, PhD

Yale University

Information Provided By

Yale University

Verification Date

August 2009

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