A Study to Assess the Pharmacodynamic Interaction Between Gabapentin and Ethanol in Healthy Subjects
NCT ID: NCT00666796
Last Updated: 2021-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
20 participants
INTERVENTIONAL
2005-04-30
2005-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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A
Placebo
Matched placebo oral capsule with 8 oz of water 2 hours prior to assessment timepoint
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
B
Gabapentin
Gabapentin 500 mg oral capsule with 8 oz of water 2 hours prior to assessment timepoint
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
C
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
Placebo
Matched placebo oral capsule with 8 oz of water 2 hours prior to assessment timepoint
D
Gabapentin
Gabapentin 500 mg oral capsule with 8 oz of water 2 hours prior to assessment timepoint
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
Interventions
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Placebo
Matched placebo oral capsule with 8 oz of water 2 hours prior to assessment timepoint
Gabapentin
Gabapentin 500 mg oral capsule with 8 oz of water 2 hours prior to assessment timepoint
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
Placebo
Matched placebo oral capsule with 8 oz of water 2 hours prior to assessment timepoint
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
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
Gabapentin
Gabapentin 500 mg oral capsule with 8 oz of water 2 hours prior to assessment timepoint
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 Criteria
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Inclusion Criteria
* 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 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
21 Years
50 Years
ALL
Yes
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Miami, Florida, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A9451149
Identifier Type: -
Identifier Source: org_study_id
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