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

Viatris

Status and phase: Completed; Phase 4

Conditions: Insomnia

Treatments: Drug: Placebo; Drug: Gabapentin; Drug: Placebo ethanol; Drug: Ethanol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00666796

A9451149

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 4 patient groups, including a placebo group

A

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo ethanol

Drug: Placebo ethanol

B

Experimental group

Treatment:

Drug: Gabapentin

Drug: Ethanol

Drug: Gabapentin

Drug: Ethanol

C

Experimental group

Treatment:

Drug: Placebo

Drug: Ethanol

Drug: Placebo

Drug: Ethanol

D

Experimental group

Treatment:

Drug: Gabapentin

Drug: Gabapentin

Drug: Placebo ethanol

Drug: Placebo ethanol