Physiological, Behavioral and Subjective Effects of Drugs (GHB)
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.
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.
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
sodium oxybate, triazolam and pentobarbital
Johns Hopkins University School of Medicine/Bayview Medical Center
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00058955
- Information obtained from ClinicalTrials.gov on July 15, 2010
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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.