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Sponsors and Collaborators: |
Orphan Medical Johns Hopkins University |
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Information provided by: | Orphan Medical |
ClinicalTrials.gov Identifier: | NCT00058955 |
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.
Condition | Intervention | Phase |
---|---|---|
Sedative Abuse |
Drug: sodium oxybate, triazolam and pentobarbital |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacodynamics Study |
Official Title: | Physiological, Behavioral and Subjective Effects of Drugs (GHB) |
Estimated Enrollment: | 20 |
Study Start Date: | August 2003 |
Estimated Study Completion Date: | March 2005 |
Arms | Assigned Interventions |
---|---|
1: Experimental
Sodium oxybate
|
Drug: sodium oxybate, triazolam and pentobarbital
sodium oxybate, triazolam and pentobarbital
|
2: Active Comparator
triazolam
|
Drug: sodium oxybate, triazolam and pentobarbital
sodium oxybate, triazolam and pentobarbital
|
3: Active Comparator
pentobarbital
|
Drug: sodium oxybate, triazolam and pentobarbital
sodium oxybate, triazolam and pentobarbital
|
4: Placebo Comparator
Placebo
|
Drug: sodium oxybate, triazolam and pentobarbital
sodium oxybate, triazolam and pentobarbital
|
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.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
INCLUSION CRITERIA
EXCLUSION CRITERIA
United States, Maryland | |
Johns Hopkins University School of Medicine/Bayview Medical Center | |
Baltimore, Maryland, United States, 21224 |
Principal Investigator: | Roland Griffiths, PhD | Johns Hopkins University |
Responsible Party: | Jazz Pharmaceuticals, Inc. ( Senior Director of Clinical Development ) |
Study ID Numbers: | OMC-SXB-25, BPR00-09-27-02 |
Study First Received: | April 15, 2003 |
Last Updated: | September 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00058955 |
Health Authority: | United States: Food and Drug Administration |
ghb Xyrem triazolam |
pentobarbital sedative abuse |
Pentobarbital Triazolam Sodium Oxybate |
Anesthetics, Intravenous Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action GABA Modulators Physiological Effects of Drugs Psychotropic Drugs Anesthetics Central Nervous System Depressants |
Pharmacologic Actions Adjuvants, Anesthesia Anesthetics, General Therapeutic Uses Hypnotics and Sedatives GABA Agents Anti-Anxiety Agents Central Nervous System Agents |