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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014