Physiological, Behavioral and Subjective Effects of Drugs (GHB)
NCT ID: NCT00058955
Last Updated: 2008-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2003-08-31
2005-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
CROSSOVER
PREVENTION
QUADRUPLE
Study Groups
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1
Sodium oxybate
sodium oxybate, triazolam and pentobarbital
sodium oxybate, triazolam and pentobarbital
2
triazolam
sodium oxybate, triazolam and pentobarbital
sodium oxybate, triazolam and pentobarbital
3
pentobarbital
sodium oxybate, triazolam and pentobarbital
sodium oxybate, triazolam and pentobarbital
4
Placebo
sodium oxybate, triazolam and pentobarbital
sodium oxybate, triazolam and pentobarbital
Interventions
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sodium oxybate, triazolam and pentobarbital
sodium oxybate, triazolam and pentobarbital
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
50 Years
ALL
Yes
Sponsors
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Johns Hopkins University
OTHER
Orphan Medical
INDUSTRY
Responsible Party
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Jazz Pharmaceuticals, Inc.
Principal Investigators
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Roland Griffiths, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Johns Hopkins University School of Medicine/Bayview Medical Center
Baltimore, Maryland, United States
Countries
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References
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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.
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.
Other Identifiers
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BPR00-09-27-02
Identifier Type: -
Identifier Source: secondary_id
OMC-SXB-25
Identifier Type: -
Identifier Source: org_study_id