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

Condition(s) targeted: Insomnia

Intervention: Placebo ethanol (Drug); Ethanol (Drug); Placebo (Drug); Gabapentin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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

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 design: Basic Science, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Crossover Assignment, Pharmacodynamics Study

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

Secondary outcome:

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

Change from pre-dose in PVT for ITT subjects

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

Change from pre-dose in BSRT for ITT subjects

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

Change from pre-dose in SSS for ITT subjects

Adverse events

Vital signs

Change from pre-dose in PVT for completed subjects

Change from pre-dose in Digit Symbol Substitution Test (DSST) for completed subjects

Minimum age: 21 Years. Maximum age: 50 Years. Gender(s): Both.

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

Pfizer Investigational Site, Miami, Florida 33181, United States

To obtain contact information for a study center near you, click here.

Link to ClinicalStudyResults.org Posting

Starting date: April 2005
Ending date: May 2005
Last updated: April 23, 2008