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

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ClinicalTrials.gov Identifier: NCT00580853
Recruitment Status : Completed
First Posted : December 27, 2007
Results First Posted : March 10, 2017
Last Update Posted : February 8, 2018
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Yale University

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Smoking Lapse Behavior Drug: varenicline Drug: bupropion Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Varenicline (Chantix) and Bupropion (Zyban) on Smoking Lapse Behavior
Study Start Date : April 2007
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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


Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00580853     History of Changes
Other Study ID Numbers: 0702002390
P50AA015632 ( U.S. NIH Grant/Contract )
First Posted: December 27, 2007    Key Record Dates
Results First Posted: March 10, 2017
Last Update Posted: February 8, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by 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