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

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

Study Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Drug: Placebo ethanol; Drug: Placebo; Drug: Ethanol; Drug: Gabapentin

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33181
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: B	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: Gabapentin; Gabapentin 500 mg oral capsule with 8 oz of water 2 hours prior to assessment timepoint
Experimental: C	Drug: Placebo; Matched placebo oral capsule with 8 oz of water 2 hours 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
Experimental: D	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: Gabapentin; Gabapentin 500 mg oral capsule with 8 oz of water 2 hours prior to assessment timepoint
Placebo Comparator: A	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: Placebo; Matched placebo oral capsule with 8 oz of water 2 hours prior to assessment timepoint

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: April 1, 2005
• Study Completion (Actual): May 1, 2005

Study Registration Dates

• First Submitted: April 23, 2008
• First Submitted That Met QC Criteria: April 23, 2008
• First Posted (Estimate): April 25, 2008

Study Record Updates

• Last Update Posted (Actual): February 2, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: April 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Ethanol; Gabapentin
• Other Study ID Numbers: A9451149