The Effect of Varenicline (Chantix) and Bupropion (Zyban) on Smoking Lapse Behavior
Information source: Yale University
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Smoking Lapse Behavior
Intervention: varenicline (Drug); bupropion (Drug); Placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Yale University Official(s) and/or principal investigator(s):
Sherry A McKee, PhD, Principal Investigator, Affiliation: Yale University
Overall contact:
Sabrina Coppola, Phone: 203-737-2827
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.
Clinical Details
Official title: The Effect of Varenicline (Chantix) and Bupropion (Zyban) on Smoking Lapse Behavior
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Factorial Assignment
Primary outcome: latency to initiate ad-lib smoking session
Secondary outcome: number of cigarettes smoked during the ad-lib period
Eligibility
Minimum age: 21 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Sabrina Coppola, Phone: 203-737-2827
Yale Center for Clinical Investigation, Yale University, New Haven, Connecticut 06519, United States; Recruiting
Additional Information
Starting date: April 2007
Ending date: August 2009
Last updated: October 14, 2008
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