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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sherry McKee, Yale University
ClinicalTrials.gov Identifier:
NCT00580853
First received: December 25, 2007
Last updated: February 21, 2013
Last verified: February 2013
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: 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:

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 2014
Estimated Primary Completion Date: September 2014 (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

Locations
United States, Connecticut
Yale Center for Clinical Investigation, Yale University
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: February 21, 2013
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 May 21, 2013