The purpose of this study is to assess the pharmacodynamic interaction between gabapentin and ethanol
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
20
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
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
Matched placebo oral capsule with 8 oz of water 2 hours prior to assessment timepoint
Pfizer Investigational Site
Miami, Florida, United States
Change from pre-dose in the Psychomotor Vigilance Task (PVT) for completed subjects
Time frame: 2 hours post-dose
Change from pre-dose in DSST for Intent-to-Treat (ITTI subjects
Time frame: 2 and 6 hours post-dose
Change from pre-dose in PVT for ITT subjects
Time frame: 2 and 6 hours post-dose
Change from pre-dose in Buschke Selective Reminding Test (BSRT) for completed subjects
Time frame: 2 and 6 hours post-dose
Change from pre-dose in BSRT for ITT subjects
Time frame: 2 and 6 hours post-dose
Change from pre-dose in Stanford Sleepiness Scale (SSS) for completed subjects
Time frame: 2, 6, and 7.5 hours post-dose
Change from pre-dose in SSS for ITT subjects
Time frame: 2, 6, and 7.5 hours post-dose
Adverse events
Time frame: Throughout study duration
Vital signs
Time frame: Throughout study duration
Change from pre-dose in PVT for completed subjects
Time frame: 6 hours post-dose
Change from pre-dose in Digit Symbol Substitution Test (DSST) for completed subjects
Time frame: 2 and 6 hours post-dose
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Gabapentin 500 mg oral capsule with 8 oz of water 2 hours prior to assessment timepoint
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
Matched placebo oral capsule with 8 oz of water 2 hours prior to assessment timepoint
Gabapentin 500 mg oral capsule with 8 oz of water 2 hours prior to assessment timepoint
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