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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00666796
First received: April 23, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
  Purpose

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


Condition Intervention Phase
Insomnia
Drug: Placebo ethanol
Drug: Ethanol
Drug: Placebo
Drug: Gabapentin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from pre-dose in the Psychomotor Vigilance Task (PVT) for completed subjects [ Time Frame: 2 hours post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from pre-dose in DSST for Intent-to-Treat (ITTI subjects [ Time Frame: 2 and 6 hours post-dose ] [ Designated as safety issue: No ]
  • Change from pre-dose in PVT for ITT subjects [ Time Frame: 2 and 6 hours post-dose ] [ Designated as safety issue: No ]
  • Change from pre-dose in Buschke Selective Reminding Test (BSRT) for completed subjects [ Time Frame: 2 and 6 hours post-dose ] [ Designated as safety issue: No ]
  • Change from pre-dose in BSRT for ITT subjects [ Time Frame: 2 and 6 hours post-dose ] [ Designated as 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 ] [ Designated as safety issue: No ]
  • Change from pre-dose in SSS for ITT subjects [ Time Frame: 2, 6, and 7.5 hours post-dose ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Throughout study duration ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: Throughout study duration ] [ Designated as safety issue: Yes ]
  • Change from pre-dose in PVT for completed subjects [ Time Frame: 6 hours post-dose ] [ Designated as safety issue: No ]
  • Change from pre-dose in Digit Symbol Substitution Test (DSST) for completed subjects [ Time Frame: 2 and 6 hours post-dose ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: April 2005
Study Completion Date: May 2005
Arms Assigned Interventions
Placebo Comparator: A 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: Placebo
Matched placebo oral capsule with 8 oz of water 2 hours prior to assessment timepoint
Experimental: B 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: Gabapentin
Gabapentin 500 mg oral capsule with 8 oz of water 2 hours prior to assessment timepoint
Experimental: C 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
Experimental: D 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

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00666796

Locations
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33181
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00666796     History of Changes
Other Study ID Numbers: A9451149
Study First Received: April 23, 2008
Last Updated: April 23, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ethanol
Gabapentin
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents

ClinicalTrials.gov processed this record on April 15, 2014