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

This study has been completed.

Sponsor:

Collaborator:

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Information provided by (Responsible Party):

Sherry McKee, Yale University

ClinicalTrials.gov Identifier:

NCT00580853

First received: December 25, 2007

Last updated: January 20, 2017

Last verified: January 2017

History of Changes

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 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, 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: Smoking

Drug Information available for: Bupropion hydrochloride Bupropion Varenicline Varenicline tartrate

U.S. FDA Resources

Further study details as provided by Sherry McKee, Yale University:

Primary Outcome Measures:

Latency to Initiate Ad-lib Smoking Session [ Time Frame: 0 to 50 minutes ]
minutes to start smoking (range 0 to 50 minutes)

Secondary Outcome Measures:

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


Enrollment:	62
Study Start Date:	April 2007
Study Completion Date:	October 2016
Primary Completion Date:	October 2016 (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 (Adult)
Sexes Eligible for Study:	All
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 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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


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

Sponsors and Collaborators

Yale University

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators


Principal Investigator:	Sherry A McKee, PhD	Yale University

More Information


Responsible Party:	Sherry McKee, Associate Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier:	NCT00580853 History of Changes
Other Study ID Numbers:	HIC0702002390 P50AA015632 ( U.S. NIH Grant/Contract )
Study First Received:	December 25, 2007
Results First Received:	October 21, 2016
Last Updated:	January 20, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Sherry McKee, Yale University:


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

Additional relevant MeSH terms:


Varenicline Bupropion Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antidepressive Agents, Second-Generation	Antidepressive Agents Psychotropic Drugs Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Dopamine Agents Cytochrome P-450 CYP2D6 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 19, 2017

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