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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA015596-01 | 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 the effect of smoking cessation medications on alcohol drinking. Effect of 2mg/day, 1mg/day, placebo varenicline was evaluated.
Following 7 days of medication pre-treatment to achieve steady state levels, participants complete a laboratory session assessing alcohol self-administration behavior.
Study enrolls heavy drinking smokers (not tested under nicotine deprivation), non-daily smokers, and nonsmokers. Volunteers are administered either varenicline (Chantix) or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| varenicline | Experimental | varenicline 1mg/day or 2mg/day |
|
| Placebo | Placebo Comparator | Placebo Controlled |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| varenicline | Drug | 2mg/day or 1mg/day with 1-week medication lead-in period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Drinks Consumed | number of drinks consumed during hour 1 and hour 2 of the 120 minute alcohol self-administration session | 2 hour ad-lib drinking period, during the laboratory session (Day 8) |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol Craving | alcohol craving during the alcohol priming dose period using a visual analog scale of alcohol craving (1-100; higher scores = higher craving) | during laboratory session (Day 8) at baseline |
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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 and Yale Behavioral Pharmacology Laboratory | New Haven | Connecticut | 06519 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29389170 | Derived | Roberts W, McKee SA. Effects of varenicline on cognitive performance in heavy drinkers: Dose-response effects and associations with drinking outcomes. Exp Clin Psychopharmacol. 2018 Feb;26(1):49-57. doi: 10.1037/pha0000161. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo controlled placebo: placebo |
| FG001 | 1 mg/Day Varenicline | 1mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for days 1-5, followed by 0.5mg twice daily for days 6-7. 0.5mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session. |
| FG002 | 2 mg/Day Varenicline | 2mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for Day 1 and 2, 0.5 mg twice daily for Days 3-5, and 1.0mg twice daily on Days 6-7. 1.0mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo controlled placebo: placebo |
| BG001 | 1 mg/Day Varenicline | 1mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for days 1-5, followed by 0.5mg twice daily for days 6-7. 0.5mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session. |
| 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 | Number of Drinks Consumed | number of drinks consumed during hour 1 and hour 2 of the 120 minute alcohol self-administration session | number of drinks consumed during hour 1 and hour 2 of the 120 minute alcohol self-administration session | Posted | Mean | Standard Error | number of drinks | 2 hour ad-lib drinking period, during the laboratory session (Day 8) |
|
Titration period (8 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. Adverse events assessed on Day 1, 2, 5, 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 | Placebo | Placebo controlled placebo: placebo | 0 |
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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 School of Medicine | 203-737-3529 | sherry.mckee@yale.edu |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D015438 | Health Behavior |
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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 |
|
| BG002 | 2 mg/Day Varenicline | 2mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for Day 1 and 2, 0.5 mg twice daily for Days 3-5, and 1.0mg twice daily on Days 6-7. 1.0mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG002 | 2 mg/Day Varenicline | 2mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for Day 1 and 2, 0.5 mg twice daily for Days 3-5, and 1.0mg twice daily on Days 6-7. 1.0mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session. |
|
|
| Secondary | Alcohol Craving | alcohol craving during the alcohol priming dose period using a visual analog scale of alcohol craving (1-100; higher scores = higher craving) | n=19 in the 2mg/day varenicline group because 1 subject failed to respond on measure. | Posted | Mean | Standard Error | units on a visual analog scale | during laboratory session (Day 8) at baseline |
|
|
|
| 20 |
| 0 |
| 20 |
| 7 |
| 20 |
| EG001 | 1 mg/Day Varenicline | 1mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for days 1-5, followed by 0.5mg twice daily for days 6-7. 0.5mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session. | 0 | 20 | 0 | 20 | 4 | 20 |
| EG002 | 2 mg/Day Varenicline | 2mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for Day 1 and 2, 0.5 mg twice daily for Days 3-5, and 1.0mg twice daily on Days 6-7. 1.0mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session. | 0 | 20 | 0 | 20 | 5 | 20 |
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| 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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| Difficulty Breathing | General disorders | Systematic Assessment |
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| Shortness of Breath | General disorders | Systematic Assessment |
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| Tightness in Chest | Cardiac disorders | Systematic Assessment |
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| Abnormal Dreams | General disorders | Systematic Assessment |
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| Fast Heartbeat | Cardiac disorders | Systematic Assessment |
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| Suicidal Thoughts | General disorders | Systematic Assessment |
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| Erratic Behavior | General disorders | Systematic Assessment |
|
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| D011810 | Quinoxalines |