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

Yale University

Status and phase: Completed; Phase 2

Conditions: Smoking Lapse Behavior

Treatments: Drug: bupropion; Drug: Placebo; Drug: varenicline

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00580853

0702002390

P50AA015632 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

62 participants in 3 patient groups, including a placebo group

varenicline

Experimental group

Description:

varenicline 2mg/day

Treatment:

Drug: varenicline

Bupropion

Experimental group

Description:

Bupropion 300mg/day

Treatment:

Drug: bupropion

Placebo

Placebo Comparator group

Description:

Placebo Control

Treatment:

Drug: Placebo