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

Insomnia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00666796
• Other study ID #: A9451149
• Status: Completed
• Phase: Phase 4
• Start date: April 2005
• Est. completion date: May 2005

Study information

• Verified date: April 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from pre-dose in the Psychomotor Vigilance Task (PVT) for completed subjects		2 hours post-dose
Secondary	Change from pre-dose in DSST for Intent-to-Treat (ITTI subjects		2 and 6 hours post-dose
Secondary	Change from pre-dose in PVT for ITT subjects		2 and 6 hours post-dose
Secondary	Change from pre-dose in Buschke Selective Reminding Test (BSRT) for completed subjects		2 and 6 hours post-dose
Secondary	Change from pre-dose in BSRT for ITT subjects		2 and 6 hours post-dose
Secondary	Change from pre-dose in Stanford Sleepiness Scale (SSS) for completed subjects		2, 6, and 7.5 hours post-dose
Secondary	Change from pre-dose in SSS for ITT subjects		2, 6, and 7.5 hours post-dose
Secondary	Adverse events		Throughout study duration
Secondary	Vital signs		Throughout study duration
Secondary	Change from pre-dose in PVT for completed subjects		6 hours post-dose
Secondary	Change from pre-dose in Digit Symbol Substitution Test (DSST) for completed subjects		2 and 6 hours post-dose

External Links

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