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

Phase 2

Completed

• Conditions: Smoking Lapse Behavior
• Interventions: Drug: bupropion; Drug: Placebo; Drug: varenicline

• Registration Number: NCT00580853
• Lead Sponsor: Yale University

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

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-12-25
• Study First Submitted QC: 2007-12-26
• Study First Posted: 2007-12-27
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Results First Submitted: 2016-10-21
• Results First Submitted QC: 2017-01-20
• Results First Posted: 2017-03-10
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-12
• Last Update Posted: 2018-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupropion	bupropion	Bupropion 300mg/day
Placebo	Placebo	Placebo Control
varenicline	varenicline	varenicline 2mg/day

Primary Outcome Measures

Name	Time	Method
Latency to Initiate Ad-lib Smoking Session	0 to 50 minutes	minutes to start smoking (range 0 to 50 minutes)

Secondary Outcome Measures

Name	Time	Method
Number of Cigarettes Smoked During the 60 Minute Ad-lib Period	60 minutes	number of cigarettes smoked (range 0-8) during the 60 minute ad-lib period

Trial Locations

Locations (1)

Yale Center for Clinical Investigation, Yale University; 🇺🇸 New Haven, Connecticut, United States