Physiological, Behavioral and Subjective Effects of Drugs (GHB)
- Conditions
- Sedative Abuse
- Interventions
- Registration Number
- NCT00058955
- Lead Sponsor
- Orphan Medical
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 4 sodium oxybate, triazolam and pentobarbital Placebo 1 sodium oxybate, triazolam and pentobarbital Sodium oxybate 2 sodium oxybate, triazolam and pentobarbital triazolam 3 sodium oxybate, triazolam and pentobarbital pentobarbital
- Primary Outcome Measures
Name Time Method Pharmacokinetics
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Johns Hopkins University School of Medicine/Bayview Medical Center
🇺🇸Baltimore, Maryland, United States