Clinical trial NCT00666796: A Study to Assess the Pharmacodynamic Interaction Between Gabapentin and Ethanol in Healthy Subjects
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Insomnia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-25
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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

Primary outcomes:
measure: Change from pre-dose in the Psychomotor Vigilance Task (PVT) for completed subjects
timeFrame: 2 hours post-dose
Secondary outcomes:
measure: Change from pre-dose in DSST for Intent-to-Treat (ITTI subjects
timeFrame: 2 and 6 hours post-dose
measure: Change from pre-dose in PVT for ITT subjects
timeFrame: 2 and 6 hours post-dose
measure: Change from pre-dose in Buschke Selective Reminding Test (BSRT) for completed subjects
timeFrame: 2 and 6 hours post-dose
measure: Change from pre-dose in BSRT for ITT subjects
timeFrame: 2 and 6 hours post-dose
measure: Change from pre-dose in Stanford Sleepiness Scale (SSS) for completed subjects
timeFrame: 2, 6, and 7.5 hours post-dose
measure: Change from pre-dose in SSS for ITT subjects
timeFrame: 2, 6, and 7.5 hours post-dose
measure: Adverse events
timeFrame: Throughout study duration
measure: Vital signs
timeFrame: Throughout study duration
measure: Change from pre-dose in PVT for completed subjects
timeFrame: 6 hours post-dose
measure: Change from pre-dose in Digit Symbol Substitution Test (DSST) for completed subjects
timeFrame: 2 and 6 hours post-dose
Other outcomes:
Locations:
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: