Physiological, Behavioral and Subjective Effects of Drugs (GHB)

September 9, 2008 updated by: Orphan Medical
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 4
Placebo
Drug: sodium oxybate, triazolam and pentobarbital
sodium oxybate, triazolam and pentobarbital
Other Names:
  • Xyrem
Experimental: 1
Sodium oxybate
Drug: sodium oxybate, triazolam and pentobarbital
sodium oxybate, triazolam and pentobarbital
Other Names:
  • Xyrem
Active Comparator: 2
triazolam
Drug: sodium oxybate, triazolam and pentobarbital
sodium oxybate, triazolam and pentobarbital
Other Names:
  • Xyrem
Active Comparator: 3
pentobarbital
Drug: sodium oxybate, triazolam and pentobarbital
sodium oxybate, triazolam and pentobarbital
Other Names:
  • Xyrem

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pharmacokinetics

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orphan Medical

Collaborators

Johns Hopkins University

Investigators

  • Principal Investigator: Roland Griffiths, PhD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Study Completion

March 1, 2005

Study Registration Dates

First Submitted

April 15, 2003

First Submitted That Met QC Criteria

April 15, 2003

First Posted (Estimate)

April 16, 2003

Study Record Updates

Last Update Posted (Estimate)

September 10, 2008

Last Update Submitted That Met QC Criteria

September 9, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OMC-SXB-25
  • BPR00-09-27-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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