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
  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 1

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:


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:
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 April 23, 2014