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| ID | Type | Description | Link |
|---|---|---|---|
| R44AA152200 | Other Grant/Funding Number | NIAAA |
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This research is designed to assess the impact of pretreatment with puerarin (NPI-031G), a major ingredient in the plant kudzu, on alcohol drinking. Hypothesis: Short-term treatment with this compound will reduce alcohol self-administration in a simulated natural settings laboratory.
Participants will have an opportunity to drink up to 6 beers, plus water and juice, during a 90 minute afternoon drinking session in our simulated apartment room laboratory. Drinking sessions will be conducted in the afternoon after participants take puerarin or placebo for 7 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Puerarin | Active Comparator |
| |
| Placebo | Placebo Comparator | Sugar beet filler in capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Puerarin, Placebo | Drug | 400 mg, three times a day for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amount of Alcohol Consumed | During a 90 minute drinking session |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David M. Penetar, PhD | Mclean Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McLean Hospital, Behavioral Psychopharmacology Research Laboratory | Belmont | Massachusetts | 02478 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15897719 | Background | Lukas SE, Penetar D, Berko J, Vicens L, Palmer C, Mallya G, Macklin EA, Lee DY. An extract of the Chinese herbal root kudzu reduces alcohol drinking by heavy drinkers in a naturalistic setting. Alcohol Clin Exp Res. 2005 May;29(5):756-62. doi: 10.1097/01.alc.0000163499.64347.92. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo, Then Puerarin | |
| FG001 | Puerarin, Then Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| ||||||||||||||||||
| Washout |
| |||||||||||||||||||
| Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo, Then Puerarin | |
| BG001 | Puerarin, Then Placebo | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Amount of Alcohol Consumed | Posted | Mean | Standard Error | Number of drinks consumed | During a 90 minute drinking session |
|
|
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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, Then Puerarin |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David M. Penetar | BPRL, McLean Hospital | 617-855-2913 | dpenetar@mclean.harvard.edu |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C033607 | puerarin |
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| NOT COMPLETED |
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| NOT COMPLETED |
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Total of all reporting groups
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 8 |
| 4 |
| 8 |
| EG001 | Puerarin, Then Placebo | 0 | 8 | 3 | 8 |
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Urinary Tract infection | Renal and urinary disorders | Non-systematic Assessment |
|
| Cheek Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Elevated Liver Enzymes | Hepatobiliary disorders | Systematic Assessment |
|
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