Physiological, Behavioral and Subjective Effects of Drugs (GHB)

This study has been completed.

Sponsor:

Collaborator:

Johns Hopkins University

Information provided by:

Orphan Medical

ClinicalTrials.gov Identifier:

NCT00058955

First received: April 15, 2003

Last updated: September 9, 2008

Last verified: September 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

April 15, 2003

Last Updated Date

September 9, 2008

Start Date ^ICMJE

August 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Pharmacokinetics [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00058955 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Physiological, Behavioral and Subjective Effects of Drugs (GHB)

Official Title ^ICMJE

Physiological, Behavioral and Subjective Effects of Drugs (GHB)

Brief 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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Sedative Abuse

Intervention ^ICMJE

Drug: sodium oxybate, triazolam and pentobarbital

sodium oxybate, triazolam and pentobarbital

Other Name: Xyrem

Study Arm (s)

Experimental: 1
Sodium oxybate

Intervention: Drug: sodium oxybate, triazolam and pentobarbital
Active Comparator: 2
triazolam

Intervention: Drug: sodium oxybate, triazolam and pentobarbital
Active Comparator: 3
pentobarbital

Intervention: Drug: sodium oxybate, triazolam and pentobarbital
Placebo Comparator: 4
Placebo

Intervention: Drug: sodium oxybate, triazolam and pentobarbital

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

March 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00058955

Other Study ID Numbers ^ICMJE

OMC-SXB-25, BPR00-09-27-02

Has Data Monitoring Committee

Responsible Party

Senior Director of Clinical Development, Jazz Pharmaceuticals, Inc.

Study Sponsor ^ICMJE

Orphan Medical

Collaborators ^ICMJE

Johns Hopkins University

Investigators ^ICMJE

Principal Investigator:

Roland Griffiths, PhD

Johns Hopkins University

Information Provided By

Orphan Medical

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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