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

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

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Ages Eligible for Study: | 21 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, Connecticut | |
Yale Center for Clinical Investigation, Yale University | |
New Haven, Connecticut, United States, 06519 |
Principal Investigator: | Sherry A McKee, PhD | Yale University |
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 |