Clinical trial NCT00058955: Physiological, Behavioral and Subjective Effects of Drugs (GHB)
Official title: Physiological, Behavioral and Subjective Effects of Drugs (GHB)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sedative Abuse
Keywords: ghb
Xyrem
triazolam
pentobarbital
sedative
abuse
Lead sponsor: Orphan Medical
Sponsor class: INDUSTRY
Collaborators: name: Johns Hopkins University
First posted: 2003-04-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: Pharmacokinetics
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine/Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Roland Griffiths, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.