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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00666796

Enrollment

Registered

2008-04-25

Start date

2005-04-30

Completion date

2005-05-31

Last updated

2021-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Brief summary

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

Interventions

DRUGPlacebo 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

DRUGEthanol

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

DRUGPlacebo

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

DRUGGabapentin

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Change from pre-dose in the Psychomotor Vigilance Task (PVT) for completed subjects	2 hours post-dose

Secondary

Measure	Time frame
Change from pre-dose in PVT for completed subjects	6 hours post-dose
Change from pre-dose in Stanford Sleepiness Scale (SSS) for completed subjects	2, 6, and 7.5 hours post-dose
Change from pre-dose in SSS for ITT subjects	2, 6, and 7.5 hours post-dose
Change from pre-dose in Digit Symbol Substitution Test (DSST) for completed subjects	2 and 6 hours post-dose
Vital signs	Throughout study duration
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 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
Adverse events	Throughout study duration

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026