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

Smoking Lapse Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00580853
• Other study ID #: 0702002390
• Secondary ID: P50AA015632
• Status: Completed
• Phase: Phase 2
• First received: December 25, 2007
• Last updated: January 12, 2018
• Start date: April 2007
• Est. completion date: October 2016

Study information

• Verified date: January 2018
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Smoking Lapse Behavior

Intervention

Drug:
• 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).
• 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).
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Yale Center for Clinical Investigation, Yale University	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Latency to Initiate Ad-lib Smoking Session	minutes to start smoking (range 0 to 50 minutes)	0 to 50 minutes
Secondary	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