Physiological, Behavioral and Subjective Effects of Drugs (GHB)

Study Overview
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Brief Summary
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The purpose of this study is to learn more about the effects of gamma-hydroxybutyric acid (GHB) by comparing its physiological, behavioral and subjective effects with those of several other drugs.

Detailed Description
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The purpose of this study is to learn more about the effects of gamma-hydroxybutyric acid by comparing its physiological, behavioral and subjective effects with those of several other drugs. This trial will be conducted as a double-blind, double-dummy, placebo-controlled, counter-balanced (Latin-square design) crossover study in volunteers with histories of sedative abuse. Volunteers will be recruited through advertising and word-of-mouth. Volunteers will reside on our residential research unit for the duration of the study and participate in a maximum of 16 experimental sessions. Sessions will be conducted five days a week (Monday through Friday). The primary subjective and behavioral measures will be taken before drug administration and at 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours after drug administration.

Official Title
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Physiological, Behavioral and Subjective Effects of Drugs (GHB)

Conditions
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Sedative Abuse

Intervention / Treatment
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* Drug: sodium oxybate, triazolam and pentobarbital


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA are ages 18-50 years have histories of sedative (e.g., GHB, alcohol, benzodiazepine or barbiturate) abuse are within 20% of their ideal body weight are healthy as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, and routine medical blood and urinalysis laboratory tests are not currently pregnant or breast-feeding, if female have signed and dated an informed consent form prior to beginning the study are willing and able to participate EXCLUSION CRITERIA have a history or current serious medical or psychiatric conditions, including (but not limited to): heart condition, lung disease, diabetes, seizure disorders, significant gastrointestinal disturbances, narrow angle glaucoma, ulcers, sleep apnea, schizophrenia, personality disorder, bipolar disorder, paranoia, multiple personality disorder have hypersensitivity/allergy or other contraindications to sedatives or stimulants are physically dependent on alcohol or other drugs, excluding nicotine and caffeine are females who are pregnant or are breast feeding are females who become pregnant during the study as evaluated using periodic pregnancy tests

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Sodium oxybate | Drug: sodium oxybate, triazolam and pentobarbital<br>* sodium oxybate, triazolam and pentobarbital<br>* Other names: Xyrem;|
| Active Comparator: 2<br>triazolam | Drug: sodium oxybate, triazolam and pentobarbital<br>* sodium oxybate, triazolam and pentobarbital<br>* Other names: Xyrem;|
| Active Comparator: 3<br>pentobarbital | Drug: sodium oxybate, triazolam and pentobarbital<br>* sodium oxybate, triazolam and pentobarbital<br>* Other names: Xyrem;|
| Placebo Comparator: 4<br>Placebo | Drug: sodium oxybate, triazolam and pentobarbital<br>* sodium oxybate, triazolam and pentobarbital<br>* Other names: Xyrem;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ghb, Xyrem, triazolam, pentobarbital, sedative, abuse