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

Study Overview
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Brief Summary
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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.

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

Conditions
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Smoking Lapse Behavior

Intervention / Treatment
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* Drug: varenicline
* Drug: bupropion
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: varenicline<br>varenicline 2mg/day | Drug: varenicline<br>* 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).<br>* Other names: Chantix;|
| Experimental: Bupropion<br>Bupropion 300mg/day | Drug: bupropion<br>* 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).<br>* Other names: Zyban;|
| Placebo Comparator: Placebo<br>Placebo Control | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Latency to Initiate Ad-lib Smoking Session | minutes to start smoking (range 0 to 50 minutes) | 0 to 50 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Cigarettes Smoked During the 60 Minute Ad-lib Period | number of cigarettes smoked (range 0-8) during the 60 minute ad-lib period | 60 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking lapse behavior, smoking cessation, varenicline, bupropion, medication effect on smoking lapse behavior