Physiological, Behavioral and Subjective Effects of Drugs (GHB) - Full Text View

Sponsor:	Orphan Medical
Collaborator:	Johns Hopkins University
Information provided by:	Orphan Medical
ClinicalTrials.gov Identifier:	NCT00058955

Purpose

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:	Allocation: Non-Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Physiological, Behavioral and Subjective Effects of Drugs (GHB)

Resource links provided by NLM:

MedlinePlus related topics: Club Drugs

Drug Information available for: Pentobarbital sodium Triazolam Pentobarbital Sodium oxybate

U.S. FDA Resources

Further study details as provided by Orphan Medical:

Primary Outcome Measures:

Pharmacokinetics [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	August 2003
Estimated Study Completion Date:	March 2005

Arms	Assigned Interventions
Experimental: 1 Sodium oxybate	Drug: sodium oxybate, triazolam and pentobarbital sodium oxybate, triazolam and pentobarbital Other Name: Xyrem
Active Comparator: 2 triazolam	Drug: sodium oxybate, triazolam and pentobarbital sodium oxybate, triazolam and pentobarbital Other Name: Xyrem
Active Comparator: 3 pentobarbital	Drug: sodium oxybate, triazolam and pentobarbital sodium oxybate, triazolam and pentobarbital Other Name: Xyrem
Placebo Comparator: 4 Placebo	Drug: sodium oxybate, triazolam and pentobarbital sodium oxybate, triazolam and pentobarbital Other Name: Xyrem

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00058955

Locations

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

Sponsors and Collaborators

Orphan Medical

Johns Hopkins University

Investigators

Principal Investigator:

Roland Griffiths, PhD

Johns Hopkins University

More Information

Publications:

[No authors listed] A 12-month, open-label, multicenter extension trial of orally administered sodium oxybate for the treatment of narcolepsy. Sleep. 2003 Feb 1;26(1):31-5.

[No authors listed] A randomized, double blind, placebo-controlled multicenter trial comparing the effects of three doses of orally administered sodium oxybate with placebo for the treatment of narcolepsy. Sleep. 2002 Feb 1;25(1):42-9.

Responsible Party:	Senior Director of Clinical Development, Jazz Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00058955 History of Changes
Other Study ID Numbers:	OMC-SXB-25, BPR00-09-27-02
Study First Received:	April 15, 2003
Last Updated:	September 9, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Orphan Medical:

ghb
Xyrem
triazolam

pentobarbital
sedative
abuse

Additional relevant MeSH terms:

Substance-Related Disorders
Mental Disorders
Sodium Oxybate
Pentobarbital
Triazolam
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anesthetics, Intravenous
Anesthetics, General

Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on February 12, 2012