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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 medications thought to attenuate the effects of alcohol (naltrexone) and smoking cessation medications (varenicline) affect the ability to resist smoking and also subsequent ad-lib smoking, following a low-dose alcohol priming drink, in non-treatment seeking alcohol-drinking daily smokers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| naltrexone + varenicline | Experimental | naltrexone (25mg) + varenicline (2mg) |
|
| varenicline | Experimental | varenicline 2mg |
|
| placebo | Placebo Comparator | placebo control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| naltrexone | Drug | 25 mg/day, with 1-week lead-in medication period. The starting dose is 0 mg/day for days 1-3, followed by 12.5mg/day for day 4, followed by 25mg/day for days 5-7, plus during the laboratory session (day 8). |
| Measure | Description | Time Frame |
|---|---|---|
| Latency to Initiate Ad-lib Smoking Session | Time to smoking during the smoking delay task. Smoking delay task occurred on day 8 of the study. Range of time delay is 0 minutes to 50 minutes. | day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Cigarettes Smoked During the Ad-lib Period | Number of cigarettes smoked during the ad libitum phase of the smoking delay task. Task occurred on day 8 of the study. | day 8 |
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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 | Naltrexone + Varenicline | naltrexone (25mg) + varenicline (2mg) naltrexone: 25 mg/day, with 1-week lead-in medication period. The starting dose is 0 mg/day for days 1-3, followed by 12.5mg/day for day 4, followed by 25mg/day for days 5-7, plus during the laboratory session (day 8). varenicline: 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8). |
| FG001 | Varenicline | varenicline 2mg varenicline: 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the 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 | Naltrexone + Varenicline | naltrexone (25mg) + varenicline (2mg) naltrexone: 25 mg/day, with 1-week lead-in medication period. The starting dose is 0 mg/day for days 1-3, followed by 12.5mg/day for day 4, followed by 25mg/day for days 5-7, plus during the laboratory session (day 8). varenicline: 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8). |
| 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 | Time to smoking during the smoking delay task. Smoking delay task occurred on day 8 of the study. Range of time delay is 0 minutes to 50 minutes. | Posted | Mean | Standard Error | minutes | 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 | Naltrexone + Varenicline | naltrexone (25mg) + varenicline (2mg) naltrexone: 25 mg/day, with 1-week lead-in medication period. The starting dose is 0 mg/day for days 1-3, followed by 12.5mg/day for day 4, followed by 25mg/day for days 5-7, plus during the laboratory session (day 8). varenicline: 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea/vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sherry McKee, PhD | Yale School of Medicine | 2037373529 | sherry.mckee@yale.edu |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D009271 | Naltrexone |
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 |
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| varenicline | Drug | 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8). |
|
|
| placebo | Drug | placebo |
|
| BG001 | Varenicline | varenicline 2mg varenicline: 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the 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 |
|
varenicline 2mg varenicline: 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8). |
| OG002 | Placebo | placebo control placebo: placebo |
|
|
| Secondary | Number of Cigarettes Smoked During the Ad-lib Period | Number of cigarettes smoked during the ad libitum phase of the smoking delay task. Task occurred on day 8 of the study. | Posted | Mean | Standard Error | cigarettes | day 8 |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 3 |
| 11 |
| EG001 | Varenicline | varenicline 2mg varenicline: 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8). | 0 | 9 | 0 | 9 | 5 | 9 |
| EG002 | Placebo | placebo control placebo: placebo | 0 | 10 | 0 | 10 | 4 | 10 |
| Headache | General disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | Systematic Assessment |
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| Abnormal dreams | General disorders | Systematic Assessment |
|
| Abdominal pain | General disorders | Systematic Assessment |
|
| Erratic Behavior | General disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Dry mouth | General disorders | Systematic Assessment |
|
| Insomnia | General disorders | Systematic Assessment |
|
| Difficulty Breathing | General disorders | Systematic Assessment |
|
| Tight chest | General disorders | Systematic Assessment |
|
| Fast heartbeat | Cardiac disorders | Systematic Assessment |
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| Suicidal Thoughts | General disorders | Systematic Assessment |
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| Depressed Mood | General disorders | Systematic Assessment |
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| Appetite change | General disorders | Systematic Assessment |
|
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| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D011810 | Quinoxalines |