NCT00058955

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 16, 2003

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2003

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
Last Updated

September 10, 2008

Status Verified

September 1, 2008

First QC Date

April 15, 2003

Last Update Submit

September 9, 2008

Conditions

Sedative Abuse

Keywords

ghbXyremtriazolampentobarbitalsedativeabuse

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics

Study Arms (4)

1

EXPERIMENTAL

Sodium oxybate

Drug: sodium oxybate, triazolam and pentobarbital

2

ACTIVE COMPARATOR

triazolam

Drug: sodium oxybate, triazolam and pentobarbital

3

ACTIVE COMPARATOR

pentobarbital

Drug: sodium oxybate, triazolam and pentobarbital

4

PLACEBO COMPARATOR

Placebo

Drug: sodium oxybate, triazolam and pentobarbital

Interventions

sodium oxybate, triazolam and pentobarbitalDRUG

sodium oxybate, triazolam and pentobarbital

Also known as: Xyrem
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Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University School of Medicine/Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (2)

  • 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.

    PMID: 12627729BACKGROUND

  • 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.

    PMID: 11833860BACKGROUND

MeSH Terms

Interventions

Sodium OxybateTriazolamPentobarbital

Intervention Hierarchy (Ancestors)

HydroxybutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsBarbituratesPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Roland Griffiths, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 15, 2003

First Posted

April 16, 2003

Study Start

August 1, 2003

Study Completion

March 1, 2005

Last Updated

September 10, 2008

Record last verified: 2008-09

Locations

US(1)