Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00666796
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00666796
Recruitment Status : Completed
First Posted : April 25, 2008
Last Update Posted : February 2, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Tracking Information
First Submitted Date  ICMJE April 23, 2008
First Posted Date  ICMJE April 25, 2008
Last Update Posted Date February 2, 2021
Study Start Date  ICMJE April 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2008)
Change from pre-dose in the Psychomotor Vigilance Task (PVT) for completed subjects [ Time Frame: 2 hours post-dose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2008)
  • Change from pre-dose in DSST for Intent-to-Treat (ITTI subjects [ Time Frame: 2 and 6 hours post-dose ]
  • Change from pre-dose in PVT for ITT subjects [ Time Frame: 2 and 6 hours post-dose ]
  • Change from pre-dose in Buschke Selective Reminding Test (BSRT) for completed subjects [ Time Frame: 2 and 6 hours post-dose ]
  • Change from pre-dose in BSRT for ITT subjects [ Time Frame: 2 and 6 hours post-dose ]
  • Change from pre-dose in Stanford Sleepiness Scale (SSS) for completed subjects [ Time Frame: 2, 6, and 7.5 hours post-dose ]
  • Change from pre-dose in SSS for ITT subjects [ Time Frame: 2, 6, and 7.5 hours post-dose ]
  • Adverse events [ Time Frame: Throughout study duration ]
  • Vital signs [ Time Frame: Throughout study duration ]
  • Change from pre-dose in PVT for completed subjects [ Time Frame: 6 hours post-dose ]
  • Change from pre-dose in Digit Symbol Substitution Test (DSST) for completed subjects [ Time Frame: 2 and 6 hours post-dose ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
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