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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Miami, Florida, 33181 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Insomnia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-50 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00666796
Pfizer
Completed
A Study to Assess the Pharmacodynamic Interaction Between Gabapentin and Ethanol in Healthy Subjects

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A Study to Assess the Pharmacodynamic Interaction Between Gabapentin and Ethanol in Healthy Subjects
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
The purpose of this study is to assess the pharmacodynamic interaction between gabapentin and ethanol
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Insomnia
  • 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: 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
  • Drug: Gabapentin
    Gabapentin 500 mg oral capsule with 8 oz of water 2 hours prior to assessment timepoint
  • Placebo Comparator: A
    Interventions:
    • Drug: Placebo ethanol
    • Drug: Placebo
  • Experimental: B
    Interventions:
    • Drug: Ethanol
    • Drug: Gabapentin
  • Experimental: C
    Interventions:
    • Drug: Ethanol
    • Drug: Placebo
  • Experimental: D
    Interventions:
    • Drug: Gabapentin
    • Drug: Placebo ethanol
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
May 2005
Not Provided

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
Sexes Eligible for Study: All
21 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00666796
A9451149
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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