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| ID | Type | Description | Link |
|---|---|---|---|
| P50AA015632 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| varenicline | Experimental | varenicline 2mg/day |
|
| Bupropion | Experimental | Bupropion 300mg/day |
|
| Placebo | Placebo Comparator | Placebo Control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| varenicline | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Latency to Initiate Ad-lib Smoking Session | minutes to start smoking (range 0 to 50 minutes) | 0 to 50 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Cigarettes Smoked During the 60 Minute Ad-lib Period | number of cigarettes smoked (range 0-8) during the 60 minute ad-lib period | 60 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sherry A McKee, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Center for Clinical Investigation, Yale University | New Haven | Connecticut | 06519 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Varenicline | varenicline 2mg/day 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). |
| FG001 | Bupropion | Bupropion 300mg/day 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). |
| FG002 | Placebo | Placebo Control Placebo: Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Varenicline | varenicline 2mg/day 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). |
| BG001 | Bupropion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Latency to Initiate Ad-lib Smoking Session | minutes to start smoking (range 0 to 50 minutes) | Subsample with high nicotine dependence | Posted | Mean | Standard Error | minutes | 0 to 50 minutes |
|
Titration period (7 days)
All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (>5% from placebo according to manufacturer) associated with varenicline and bupropion. Adverse events assessed on Day 2 and Day 8.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Varenicline | varenicline 2mg/day 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sherry McKee PhD | Yale University | 203-737-3529 | sherry.mckee@yale.edu |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000068580 | Varenicline |
| D016642 | Bupropion |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
| bupropion | Drug | 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). |
|
|
| Placebo | Drug | Placebo |
|
Bupropion 300mg/day 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). |
| BG002 | Placebo | Placebo Control Placebo: Placebo |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | Placebo | Placebo Control Placebo: Placebo |
|
|
| Secondary | Number of Cigarettes Smoked During the 60 Minute Ad-lib Period | number of cigarettes smoked (range 0-8) during the 60 minute ad-lib period | Posted | Mean | Standard Error | number of cigarettes | 60 minutes |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 13 |
| 20 |
| EG001 | Bupropion | Bupropion 300mg/day 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). | 0 | 21 | 0 | 21 | 13 | 21 |
| EG002 | Placebo | Placebo Control Placebo: Placebo | 0 | 21 | 0 | 21 | 13 | 21 |
| need to urinate | Renal and urinary disorders | Systematic Assessment |
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| Dry mouth | General disorders | Systematic Assessment |
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| Insomnia | General disorders | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | Systematic Assessment |
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| Abnormal dreams | General disorders | Systematic Assessment |
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| Discomfort | General disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Change in taste | General disorders | Systematic Assessment |
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| Runny nose | General disorders | Systematic Assessment |
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| Change in appetite | General disorders | Systematic Assessment |
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| Trouble concentrating | General disorders | Systematic Assessment |
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| Sweating | General disorders | Systematic Assessment |
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| Heartburn | Gastrointestinal disorders | Systematic Assessment |
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| Cough | General disorders | Systematic Assessment |
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| Drowsiness | General disorders | Systematic Assessment |
|
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| D011810 | Quinoxalines |
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |