A Study to Assess the Pharmacodynamic Interaction Between Gabapentin and Ethanol in Healthy Subjects
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ClinicalTrials.gov Identifier: NCT00666796 |
Recruitment Status :
Completed
First Posted : April 25, 2008
Last Update Posted : February 2, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Insomnia | Drug: Placebo ethanol Drug: Ethanol Drug: Placebo Drug: Gabapentin | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Basic Science |
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 Start Date : | April 2005 |
Actual Study Completion Date : | May 2005 |

Arm | Intervention/treatment |
---|---|
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 |
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: 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: Placebo Matched placebo oral capsule with 8 oz of water 2 hours prior to assessment timepoint |
Experimental: D |
Drug: Gabapentin
Gabapentin 500 mg oral capsule with 8 oz of water 2 hours prior to assessment timepoint 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 |
- Change from pre-dose in the Psychomotor Vigilance Task (PVT) for completed subjects [ Time Frame: 2 hours post-dose ]
- Change from pre-dose in DSST for Intent-to-Treat (ITTI subjects [ Time Frame: 2 and 6 hours post-dose ]
- Change from pre-dose in PVT for ITT subjects [ Time Frame: 2 and 6 hours post-dose ]
- Change from pre-dose in Buschke Selective Reminding Test (BSRT) for completed subjects [ Time Frame: 2 and 6 hours post-dose ]
- Change from pre-dose in BSRT for ITT subjects [ Time Frame: 2 and 6 hours post-dose ]
- Change from pre-dose in Stanford Sleepiness Scale (SSS) for completed subjects [ Time Frame: 2, 6, and 7.5 hours post-dose ]
- Change from pre-dose in SSS for ITT subjects [ Time Frame: 2, 6, and 7.5 hours post-dose ]
- Adverse events [ Time Frame: Throughout study duration ]
- Vital signs [ Time Frame: Throughout study duration ]
- Change from pre-dose in PVT for completed subjects [ Time Frame: 6 hours post-dose ]
- Change from pre-dose in Digit Symbol Substitution Test (DSST) for completed subjects [ Time Frame: 2 and 6 hours post-dose ]

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Ages Eligible for Study: | 21 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00666796
United States, Florida | |
Pfizer Investigational Site | |
Miami, Florida, United States, 33181 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
ClinicalTrials.gov Identifier: | NCT00666796 |
Other Study ID Numbers: |
A9451149 |
First Posted: | April 25, 2008 Key Record Dates |
Last Update Posted: | February 2, 2021 |
Last Verified: | April 2008 |
Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases Mental Disorders Ethanol Gabapentin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Anticonvulsants Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antimanic Agents Anti-Infective Agents, Local Anti-Infective Agents |