Physiological, Behavioral and Subjective Effects of Drugs (GHB)

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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.

Interventions

  • Drug: sodium oxybate, triazolam and pentobarbital
    • sodium oxybate, triazolam and pentobarbital

Arms, Groups and Cohorts

  • Experimental: 1
    • Sodium oxybate
  • Active Comparator: 2
    • triazolam
  • Active Comparator: 3
    • pentobarbital
  • Placebo Comparator: 4
    • Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Pharmacokinetics

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Orphan Medical
  • Collaborator
    • Johns Hopkins University
  • Provider of Information About this Clinical Study
    • Senior Director of Clinical Development, Jazz Pharmaceuticals, Inc.
  • Overall Official(s)
    • Roland Griffiths, PhD, Principal Investigator, Johns Hopkins University

References

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.