NCT00666796

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2005

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2008

Completed
Last Updated

February 2, 2021

Status Verified

April 1, 2008

First QC Date

April 23, 2008

Last Update Submit

February 1, 2021

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

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

    2 hours post-dose

Secondary Outcomes (10)

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

    2 and 6 hours post-dose

  • Change from pre-dose in PVT for ITT subjects

    2 and 6 hours post-dose

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

    2 and 6 hours post-dose

  • Change from pre-dose in BSRT for ITT subjects

    2 and 6 hours post-dose

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

    2, 6, and 7.5 hours post-dose

  • +5 more secondary outcomes

Study Arms (4)

A

PLACEBO COMPARATOR
Drug: Placebo ethanolDrug: Placebo

B

EXPERIMENTAL
Drug: EthanolDrug: Gabapentin

C

EXPERIMENTAL
Drug: EthanolDrug: Placebo

D

EXPERIMENTAL
Drug: GabapentinDrug: Placebo ethanol

Interventions

Placebo ethanolDRUG

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

A
EthanolDRUG

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

B
PlaceboDRUG

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

A
GabapentinDRUG

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

B

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Miami, Florida, 33181, United States

Location

Related Links

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

EthanolGabapentin

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsAminesgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2008

First Posted

April 25, 2008

Study Start

April 1, 2005

Study Completion

May 1, 2005

Last Updated

February 2, 2021

Record last verified: 2008-04

Locations

US(1)