A Study to Assess the Pharmacodynamic Interaction Between Gabapentin and Ethanol in Healthy Subjects

Study Overview
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Brief Summary
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The purpose of this study is to assess the pharmacodynamic interaction between gabapentin and ethanol

Official Title
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A Randomized, Double-Blind, 4-way Crossover, Placebo-Controlled, Single Center Trial to Evaluate the Potential Pharmacodynamic Interaction Between Gabapentin 500 mg and Ethanol in Healthy Volunteers

Conditions
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Insomnia

Intervention / Treatment
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* Drug: Placebo ethanol
* Drug: Ethanol
* Drug: Placebo
* Drug: Gabapentin
* Drug: Ethanol
* Drug: Placebo
* Drug: Gabapentin
* Drug: Placebo ethanol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Volunteers in good health aged 21 to 50 (inclusive) years who weigh 50 to 100 kg (110-220 lbs.) Experience with alcohol, defined as mild to moderate use of alcohol, ie, maximum of 14 alcoholic drinks per week Exclusion Criteria: Recent history (within 2 years) of, or current treatment for, a sleeping disorder including excessive snoring, obstructive sleep apnea or a chronic painful condition Recent history (within 2 years) of, or clinical evidence of significant unstable or uncontrolled respiratory (including asthma and congestive obstructive pulmonary disease), cardiovascular, gastrointestinal, hepatic, renal, endocrine, neurologic (including seizures), psychiatric or other chronic disease History of alcoholism or drug abuse; recreational drug use within the past 30 days; use of benzodiazepines, Ambien®, Sonata®, antidepressants or psychoactive medication within 30 days prior to screening; use of any other sedative, hypnotic, antihistamine, anticholinergic, melatonin, DHEA or herbal sleep/relaxation remedy within 7 days prior to screening

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A<br> | Drug: Placebo ethanol<br>* 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<br>Drug: Placebo<br>* Matched placebo oral capsule with 8 oz of water 2 hours prior to assessment timepoint<br>|
| Experimental: B<br> | Drug: Ethanol<br>* 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<br>Drug: Gabapentin<br>* Gabapentin 500 mg oral capsule with 8 oz of water 2 hours prior to assessment timepoint<br>|
| Experimental: C<br> | Drug: Ethanol<br>* 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<br>Drug: Placebo<br>* Matched placebo oral capsule with 8 oz of water 2 hours prior to assessment timepoint<br>|
| Experimental: D<br> | Drug: Gabapentin<br>* Gabapentin 500 mg oral capsule with 8 oz of water 2 hours prior to assessment timepoint<br>Drug: Placebo ethanol<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from pre-dose in the Psychomotor Vigilance Task (PVT) for completed subjects |  | 2 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |