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The purpose of this study is to assess the pharmacodynamic interaction between gabapentin and ethanol
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Placebo Comparator |
| |
| B | Experimental |
| |
| C | Experimental |
| |
| D | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo ethanol | Drug | Matched placebo ethanol 0.4% in a total volume of 300 mL as an orange juice cocktail (consumed within 15 minutes) at 1 hour prior to assessment timepoint |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from pre-dose in the Psychomotor Vigilance Task (PVT) for completed subjects | 2 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Change from pre-dose in DSST for Intent-to-Treat (ITTI subjects | 2 and 6 hours post-dose | |
| Change from pre-dose in PVT for ITT subjects | 2 and 6 hours post-dose | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Miami | Florida | 33181 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Ethanol | Drug | Ethanol 0.7 g/kg in a total volume of 300 mL as an orange juice cocktail (consumed within 15 minutes) at 1 hour prior to assessment timepoint |
|
| Placebo | Drug | Matched placebo oral capsule with 8 oz of water 2 hours prior to assessment timepoint |
|
| Gabapentin | Drug | Gabapentin 500 mg oral capsule with 8 oz of water 2 hours prior to assessment timepoint |
|
| Ethanol | Drug | Ethanol 0.7 g/kg in a total volume of 300 mL as an orange juice cocktail (consumed within 15 minutes) at 1 hour prior to assessment timepoint |
|
| Placebo | Drug | Matched placebo oral capsule with 8 oz of water 2 hours prior to assessment timepoint |
|
| Gabapentin | Drug | Gabapentin 500 mg oral capsule with 8 oz of water 2 hours prior to assessment timepoint |
|
| Placebo ethanol | Drug | Matched placebo ethanol 0.4% in a total volume of 300 mL as an orange juice cocktail (consumed within 15 minutes) at 1 hour prior to assessment timepoint |
|
| Change from pre-dose in Buschke Selective Reminding Test (BSRT) for completed subjects |
| 2 and 6 hours post-dose |
| Change from pre-dose in BSRT for ITT subjects | 2 and 6 hours post-dose |
| Change from pre-dose in Stanford Sleepiness Scale (SSS) for completed subjects | 2, 6, and 7.5 hours post-dose |
| Change from pre-dose in SSS for ITT subjects | 2, 6, and 7.5 hours post-dose |
| Adverse events | Throughout study duration |
| Vital signs | Throughout study duration |
| Change from pre-dose in PVT for completed subjects | 6 hours post-dose |
| Change from pre-dose in Digit Symbol Substitution Test (DSST) for completed subjects | 2 and 6 hours post-dose |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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