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

NCT00666796

Last updated date
Study Location
Pfizer Investigational Site
Miami, Florida, 33181, United States
Contact
1-800-718-1021

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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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

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

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[email protected]

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study to Assess the Pharmacodynamic Interaction Between Gabapentin and Ethanol in Healthy Subjects
Official Title  ICMJE 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
Brief Summary The purpose of this study is to assess the pharmacodynamic interaction between gabapentin and ethanol
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Insomnia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 23, 2008)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 21 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00666796
Other Study ID Numbers  ICMJE A9451149
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP