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Sponsored by: |
Yale University |
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Information provided by: | Yale University |
ClinicalTrials.gov Identifier: | NCT00580853 |
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 |
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Smoking Lapse Behavior |
Drug: varenicline Drug: bupropion Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Factorial Assignment |
Official Title: | The Effect of Varenicline (Chantix) and Bupropion (Zyban) on Smoking Lapse Behavior |
Estimated Enrollment: | 60 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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varenicline: Experimental
varenicline 2mg/day
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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).
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Bupropion: Experimental
Bupropion 300mg/day
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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).
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Placebo: Placebo Comparator
Placebo Control
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Drug: Placebo
Placebo
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Ages Eligible for Study: | 21 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sabrina Coppola | 203-737-2827 |
United States, Connecticut | |
Yale Center for Clinical Investigation, Yale University | Recruiting |
New Haven, Connecticut, United States, 06519 |
Principal Investigator: | Sherry A McKee, PhD | Yale University |
Responsible Party: | Yale University School of Medicine ( Sherry McKee ) |
Study ID Numbers: | HIC0702002390, P50AA15632 |
Study First Received: | December 25, 2007 |
Last Updated: | August 25, 2009 |
ClinicalTrials.gov Identifier: | NCT00580853 History of Changes |
Health Authority: | United States: Institutional Review Board |
smoking lapse behavior smoking cessation varenicline bupropion medication effect on smoking lapse behavior |
Dopamine Uptake Inhibitors Smoking Neurotransmitter Agents Dopamine Bupropion |
Psychotropic Drugs Dopamine Agents Antidepressive Agents, Second-Generation Antidepressive Agents Varenicline |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Pharmacologic Actions Smoking |
Habits Therapeutic Uses Bupropion Dopamine Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |