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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2016-10-31

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.

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Detailed Description

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Conditions

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Smoking Lapse Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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varenicline

varenicline 2mg/day

Group Type EXPERIMENTAL

varenicline

Intervention Type DRUG

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).

Bupropion

Bupropion 300mg/day

Group Type EXPERIMENTAL

bupropion

Intervention Type DRUG

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).

Placebo

Placebo Control

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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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).

Intervention Type 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).

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Chantix Zyban

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No