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

Official Title: “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”

The purpose of this study is to assess the pharmacodynamic interaction between gabapentin and ethanol

Intervention(s) in this Clinical Trial

• Drug: Placebo ethanol
  • 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
• Drug: Ethanol
  • 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
• Drug: Placebo
  • Matched placebo oral capsule with 8 oz of water 2 hours prior to assessment timepoint
• Drug: Gabapentin
  • Gabapentin 500 mg oral capsule with 8 oz of water 2 hours prior to assessment timepoint
• Drug: Ethanol
  • 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
• Drug: Placebo
  • Matched placebo oral capsule with 8 oz of water 2 hours prior to assessment timepoint
• Drug: Gabapentin
  • Gabapentin 500 mg oral capsule with 8 oz of water 2 hours prior to assessment timepoint
• Drug: Placebo ethanol
  • 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

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: A
• Experimental: B
• Experimental: C
• Experimental: D

Primary Measures

• Change from pre-dose in the Psychomotor Vigilance Task (PVT) for completed subjects
  • Time Frame: 2 hours post-dose
    Safety Issue?: No

Secondary Measures

• Change from pre-dose in DSST for Intent-to-Treat (ITTI subjects
  • Time Frame: 2 and 6 hours post-dose
    Safety Issue?: No
• Change from pre-dose in PVT for ITT subjects
  • Time Frame: 2 and 6 hours post-dose
    Safety Issue?: No
• Change from pre-dose in Buschke Selective Reminding Test (BSRT) for completed subjects
  • Time Frame: 2 and 6 hours post-dose
    Safety Issue?: No
• Change from pre-dose in BSRT for ITT subjects
  • Time Frame: 2 and 6 hours post-dose
    Safety Issue?: No
• Change from pre-dose in Stanford Sleepiness Scale (SSS) for completed subjects
  • Time Frame: 2, 6, and 7.5 hours post-dose
    Safety Issue?: No
• Change from pre-dose in SSS for ITT subjects
  • Time Frame: 2, 6, and 7.5 hours post-dose
    Safety Issue?: No
• Adverse events
  • Time Frame: Throughout study duration
    Safety Issue?: Yes
• Vital signs
  • Time Frame: Throughout study duration
    Safety Issue?: Yes
• Change from pre-dose in PVT for completed subjects
  • Time Frame: 6 hours post-dose
    Safety Issue?: No
• Change from pre-dose in Digit Symbol Substitution Test (DSST) for completed subjects
  • Time Frame: 2 and 6 hours post-dose
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00666796

Study ID Number: A9451149

ClinicalTrials.gov Identifier: NCT00666796

Health Authority: United States: Food and Drug Administration

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