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Completed

NCT Number: NCT00666796

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

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

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site

Miami, Florida, 33181, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo ethanol

Drug

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

Drug

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

Drug

Matched placebo oral capsule with 8 oz of water 2 hours prior to assessment timepoint

Gabapentin

Drug

Gabapentin 500 mg oral capsule with 8 oz of water 2 hours prior to assessment timepoint

Primary outcomes

  1. Change from pre-dose in the Psychomotor Vigilance Task (PVT) for completed subjects

    Time frame: 2 hours post-dose

Secondary outcomes

  1. Change from pre-dose in DSST for Intent-to-Treat (ITTI subjects

    Time frame: 2 and 6 hours post-dose

  2. Change from pre-dose in PVT for ITT subjects

    Time frame: 2 and 6 hours post-dose

  3. Change from pre-dose in Buschke Selective Reminding Test (BSRT) for completed subjects

    Time frame: 2 and 6 hours post-dose

  4. Change from pre-dose in BSRT for ITT subjects

    Time frame: 2 and 6 hours post-dose

  5. Change from pre-dose in Stanford Sleepiness Scale (SSS) for completed subjects

    Time frame: 2, 6, and 7.5 hours post-dose

  6. Change from pre-dose in SSS for ITT subjects

    Time frame: 2, 6, and 7.5 hours post-dose

  7. Adverse events

    Time frame: Throughout study duration

  8. Vital signs

    Time frame: Throughout study duration

  9. Change from pre-dose in PVT for completed subjects

    Time frame: 6 hours post-dose

  10. Change from pre-dose in Digit Symbol Substitution Test (DSST) for completed subjects

    Time frame: 2 and 6 hours post-dose

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2005
Study completion
2005
First posted
Apr 25, 2008
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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