The Effect of Varenicline (Chantix) and Bupropion (Zyban) on Smoking Lapse Behavior - Full Text View

Sponsor:	Yale University
Information provided by (Responsible Party):	Sherry McKee, Yale University
ClinicalTrials.gov Identifier:	NCT00580853

Purpose

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.

Condition	Intervention	Phase
Smoking Lapse Behavior	Drug: varenicline Drug: bupropion Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	The Effect of Varenicline (Chantix) and Bupropion (Zyban) on Smoking Lapse Behavior

Resource links provided by NLM:

MedlinePlus related topics: Quitting Smoking Smoking

Drug Information available for: Bupropion hydrochloride Bupropion Varenicline Varenicline tartrate

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:

latency to initiate ad-lib smoking session [ Time Frame: in the laboratory session ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

number of cigarettes smoked during the ad-lib period [ Time Frame: during the laboratory session ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	April 2007
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: varenicline varenicline 2mg/day	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). Other Name: Chantix
Experimental: Bupropion Bupropion 300mg/day	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). Other Name: Zyban
Placebo Comparator: Placebo Placebo Control	Drug: Placebo Placebo

Eligibility

Ages Eligible for Study:	21 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 DSM-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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00580853

Contacts

Contact: Sabrina Coppola

203-737-2827

Locations

United States, Connecticut
Yale Center for Clinical Investigation, Yale University	Recruiting
New Haven, Connecticut, United States, 06519

Sponsors and Collaborators

Yale University

Investigators

Principal Investigator:

Sherry A McKee, PhD

Yale University

More Information

No publications provided

Responsible Party:	Sherry McKee, Associate Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier:	NCT00580853 History of Changes
Other Study ID Numbers:	HIC0702002390, P50AA15632
Study First Received:	December 25, 2007
Last Updated:	January 20, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Yale University:

smoking lapse behavior
smoking cessation
varenicline
bupropion
medication effect on smoking lapse behavior

Additional relevant MeSH terms:

Smoking
Habits
Bupropion
Varenicline
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents

ClinicalTrials.gov processed this record on February 12, 2012