Physiological, Behavioral and Subjective Effects of Drugs (GHB)

23:55 EDT 19th September 2014 | BioPortfolio

Summary

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.

Description

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.

Study Design

Allocation: Non-Randomized, Control: Placebo Control, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Sedative Abuse

Intervention

sodium oxybate, triazolam and pentobarbital

Location

Johns Hopkins University School of Medicine/Bayview Medical Center
Baltimore
Maryland
United States
21224

Status

Completed

Source

Orphan Medical

Results (where available)

View Results

Links

Clinical Trials [525 Associated Clinical Trials listed on BioPortfolio]

Behavioral and Subjective Efficacy of Ramelteon in Subjects With a History of Polydrug Abuse

The purpose of this study is to determine the relative abuse potential of ramelteon, once daily (QD), compared to triazolam in subjects with a history of drug abuse.

Sodium Oxybate in Schizophrenia With Insomnia

The present protocol proposes study of the recently approved compound sodium oxybate (Xyrem), a GABAB and a g-hydroxybutyric acid (GHB) receptor agonist, for the study of persistent sympto...

Safety and Tolerability Study Comparing Sodium Oxybate Given as an Oral Solution to a Single-blinded Combination of Oral Tablets Plus Oral Solution in Subjects With Fibromyalgia

To compare the safety and tolerability of sodium oxybate given as a combination of an oral solution and oral tablets for 4 weeks in subjects with fibromyalgia (FM).

Trial Comparing the Effects of Xyrem (Sodium Oxybate) With Placebo for the Treatment of Fibromyalgia

The purpose of this study is to determine whether Xyrem (sodium oxybate) is effective when used alone to treat the pain and sleep disturbances of fibromyalgia.

Triazolam Trial In Healthy Subjects To Compare Bioavailability Between Formulations Of Triazolam To Determine Their Bioequivalence In Terms Of Rate And Magnitude Of Absorption

The purpose of this study is to compare the bioavailability of two oral formulations of Triazolam in healthy volunteers, in order to determine that they are bioequivalent.

PubMed Articles [2566 Associated PubMed Articles listed on BioPortfolio]

Sodium Oxybate: A Primer for Pharmacists in the Treatment of Narcolepsy.

The purpose of this report is to describe a 57-year-old man who was admitted to a nursing facility for physical therapy. His home medication list included sodium oxybate. This article will provide the...

Arachis hypogaea L. stem and leaf extract improves the sleep behavior of pentobarbital-treated rats.

This study was conducted to evaluate the sedative effects of Arachis hypogaea L. stem and leaf extract (AHSLE) and determine its effect pathways through γ-aminobutyric acid (GABA)-gated channels on m...

Determination of triazolam and midazolam in human plasma using gas chromatography with microelectron capture detection for clinical application.

  A method for the simple and reliable determination of triazolam and midazolam in human plasma using gas chromatography with microelectron capture detection has been developed. Samples (0.5 mL of p...

Sodium Oxybate in the Treatment of Alcohol Withdrawal Syndrome: A Randomized Double-Blind Comparative Study versus Oxazepam. The GATE 1 Trial.

Benzodiazepines (BDZs) are the gold standard in the treatment of alcohol withdrawal syndrome (AWS). Sodium oxybate (SMO) has been tested as a treatment for AWS with encouraging results. The aim of thi...

Long-term Effect of Sodium Oxybate (Xyrem®) in Spasmodic Dysphonia with Vocal Tremor.

Symptoms of spasmodic dysphonia (SD) are usually managed successfully with botulinum toxin injections. Vocal tremor (VT), which accompanies SD, has a poor response to this treatment.

Medical and Biotech [MESH] Definitions

The sodium salt of 4-hydroxybutyric acid. Anesthetic used for both induction and maintenance. It may cause bradycardia and dyskinesias.

A short-acting benzodiazepine used in the treatment of insomnia. Some countries temporarily withdrew triazolam from the market because of concerns about adverse reactions, mostly psychological, associated with higher dose ranges. Its use at lower doses with appropriate care and labeling has been reaffirmed by the FDA and most other countries.

A short-acting barbiturate that is effective as a sedative and hypnotic (but not as an anti-anxiety) agent and is usually given orally. It is prescribed more frequently for sleep induction than for sedation but, like similar agents, may lose its effectiveness by the second week of continued administration. (From AMA Drug Evaluations Annual, 1994, p236)

A quinazoline derivative with hypnotic and sedative properties. It has been withdrawn from the market in many countries because of problems with abuse. (From Martindale, The Extra Pharmacopoeia, 30th ed, p604)

Sodium or sodium compounds used in foods or as a food. The most frequently used compounds are sodium chloride or sodium glutamate.

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