A Study to Assess the Pharmacodynamic Interaction Between Gabapentin and Ethanol in Healthy Subjects - Full Text View

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:

MedlinePlus related topics: Drug Reactions

Drug Information available for: Gabapentin Gabapentin enacarbil

U.S. FDA Resources

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:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

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 May 21, 2013