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The purpose of this study is the examine the effect of varenicline on cognition to a high dose (0.08 g/dL) of alcohol (vs. placebo alcohol) over the ascending and descending limb of the blood alcohol curve.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| varenicline | Experimental | varenicline 1mg/day or 2mg/day |
|
| placebo | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| varenicline | Drug | 1mg/day or 2 mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645. |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Function as Measured by Omissions on the CPT | Cognitive function was measured using the Continuous Performance Task (CPT). The CPT assess attention and response inhibition and the main outcome was number of omissions (the number of times the target was present, but the subject did not respond) errors in response to go and stop targets. Participants are presented with "stop" and "go" targets that appear on a computer screen. They are told to press the space bar (respond) to "go" targets and to avoid pressing the space bar when "stop" targets appear. Presented in the data table are the average number of omissions (the number of times the target was present, but the subject did not respond). Higher omission rates indicate a greater level of inattention (range 0-324). | Following 3 weeks of medication. The CPT task was performed at 60 minutes following alcohol or placebo beverage consumption. |
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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 Human Behavioral Pharmacology Laboratory | New Haven | Connecticut | 06519 | United States |
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Of the n=60 subjects who completed the parent study (NCT00580645), n=44 elected to also complete the current protocol.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 mg/Day Varenicline | varenicline 1mg/day varenicline: 1mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645. |
| FG001 | 2 mg/Day Varenicline | varenicline 2mg/day varenicline: 2mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645. |
| FG002 | Placebo | placebo placebo: placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 mg/Day Varenicline | varenicline 1mg/day varenicline: 1mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645. |
| BG001 | 2 mg/Day Varenicline |
| 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 | Cognitive Function as Measured by Omissions on the CPT | Cognitive function was measured using the Continuous Performance Task (CPT). The CPT assess attention and response inhibition and the main outcome was number of omissions (the number of times the target was present, but the subject did not respond) errors in response to go and stop targets. Participants are presented with "stop" and "go" targets that appear on a computer screen. They are told to press the space bar (respond) to "go" targets and to avoid pressing the space bar when "stop" targets appear. Presented in the data table are the average number of omissions (the number of times the target was present, but the subject did not respond). Higher omission rates indicate a greater level of inattention (range 0-324). | Posted | Mean | Standard Error | Number of Omissions | Following 3 weeks of medication. The CPT task was performed at 60 minutes following alcohol or placebo beverage consumption. |
|
During the 1-week medication titration period (Days 1-8) of the parent study (NCT00580645).
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% and twice the rate seen in placebo-treated subjects) associated with varenicline. Adverse events assessed on Days 1, 2, 5 and 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 | 1 mg/Day Varenicline | varenicline 1mg/day varenicline: 1mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | 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 |
|---|---|
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
| placebo | Drug | placebo |
|
varenicline 2mg/day varenicline: 2mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645. |
| BG002 | Placebo | placebo placebo: placebo |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
varenicline 1mg/day
varenicline: 1mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645.
| OG001 | 2 mg/Day Varenicline | varenicline 2mg/day varenicline: 2mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645. |
| OG002 | Placebo | placebo placebo: placebo |
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 4 |
| 20 |
| EG001 | 2 mg/Day Varenicline | varenicline 2mg/day varenicline: 2mg/day Subjects are at steady state medication levels. They are participating during the 4-week medication period of our ongoing study, NCT00580645. | 0 | 20 | 0 | 20 | 5 | 20 |
| EG002 | Placebo | placebo placebo: placebo | 0 | 20 | 0 | 20 | 7 | 20 |
| Nausea/Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Dry Mouth | General disorders | Systematic Assessment |
|
| Insomnia | General disorders | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
|
| Difficulty Breathing | General disorders | Systematic Assessment |
|
| Shortness of Breath | General disorders | Systematic Assessment |
|
| Tightness in Chest | Cardiac disorders | Systematic Assessment |
|
| Abnormal Dreams | General disorders | Systematic Assessment |
|
| Fast Heartbeat | Cardiac disorders | Systematic Assessment |
|
| Suicidal Thoughts | General disorders | Systematic Assessment |
|
| Erratic Behavior | General disorders | Systematic Assessment |
|
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| D011810 | Quinoxalines |