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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA022285 | 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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Evaluating the effect of guanfacine on alcohol consumption. The investigators hypothesize that guanfacine versus placebo will decrease the amount of alcohol consumption (mls consumed) during the 2-hour self-administration period across two laboratory sessions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guanfacine 3mg/day | Experimental | Guanfacine 3mg/day |
|
| Guanfacine 1.5mg/day | Experimental | Guanfacine 1.5mg/day |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guanfacine 3mg/day | Drug | 3 mg/day Guanfacine with 3-week lead-in period. Maintained at steady state throughout lab sessions. After lab sessions, given taper supply of medication. Follow up 2 weeks after completion of taper. |
| Measure | Description | Time Frame |
|---|---|---|
| mL Per 15 Minutes | mL per 15 minutes during 2-hour ad-lib drinking period | 2 hour self administration period during lab sessions held on days 22 and 25 |
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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 Investigations, Yale University | New Haven | Connecticut | 06519 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Guanfacine 3mg/Day | Guanfacine 3mg/day Guanfacine 3mg/day: 3 mg/day Guanfacine with 3-week lead-in period. Maintained at steady state throughout lab sessions. After lab sessions, given taper supply of medication. Follow up 2 weeks after completion of taper. |
| FG001 | Guanfacine 1.5mg/Day | Guanfacine 1.5mg/day Guanfacine 1.5mg/day: 1.5 mg/day Guanfacine with 3-week lead-in period. Maintained at steady state throughout lab sessions. After lab sessions, given taper supply of medication. Follow up 2 weeks after completion of taper. |
| FG002 | Placebo | Placebo Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Guanfacine 3mg/Day | Guanfacine 3mg/day Guanfacine 3mg/day: 3 mg/day Guanfacine with 3-week lead-in period. Maintained at steady state throughout lab sessions. After lab sessions, given taper supply of medication. Follow up 2 weeks after completion of taper. |
| BG001 | Guanfacine 1.5mg/Day |
| 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 | mL Per 15 Minutes | mL per 15 minutes during 2-hour ad-lib drinking period | Posted | Mean | Standard Error | mls of alcohol consumed per 15 minutes | 2 hour self administration period during lab sessions held on days 22 and 25 |
|
Day 1 to Day 22
Treatment emergent adverse events
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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 | Guanfacine 3mg/Day | Guanfacine 3mg/day Guanfacine 3mg/day: 3 mg/day Guanfacine with 3-week lead-in period. Maintained at steady state throughout lab sessions. After lab sessions, given taper supply of medication. Follow up 2 weeks after completion of taper. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| somnolence | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sherry McKee | Yale School of Medicine | 2037373529 | sherry.mckee@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 21, 2021 | Apr 16, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D016316 | Guanfacine |
| ID | Term |
|---|---|
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D010648 | Phenylacetates |
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|
| Guanfacine 1.5mg/day | Drug | 1.5 mg/day Guanfacine with 3-week lead-in period. Maintained at steady state throughout lab sessions. After lab sessions, given taper supply of medication. Follow up 2 weeks after completion of taper. |
|
|
| Placebo | Drug |
|
Guanfacine 1.5mg/day Guanfacine 1.5mg/day: 1.5 mg/day Guanfacine with 3-week lead-in period. Maintained at steady state throughout lab sessions. After lab sessions, given taper supply of medication. Follow up 2 weeks after completion of taper. |
| BG002 | Placebo | Placebo Placebo |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Placebo | Placebo Placebo |
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 3 |
| 25 |
| EG001 | Guanfacine 1.5mg/Day | Guanfacine 1.5mg/day Guanfacine 1.5mg/day: 1.5 mg/day Guanfacine with 3-week lead-in period. Maintained at steady state throughout lab sessions. After lab sessions, given taper supply of medication. Follow up 2 weeks after completion of taper. | 0 | 22 | 0 | 22 | 2 | 22 |
| EG002 | Placebo | Placebo Placebo | 0 | 23 | 0 | 23 | 3 | 23 |
| fatigue | General disorders | Systematic Assessment |
|
| dizziness | General disorders | Systematic Assessment |
|
| dry mouth | Gastrointestinal disorders | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
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| D000146 |
| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |