NCT00058955

Physiological, Behavioral and Subjective Effects of Drugs (GHB)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Orphan Medical · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Sedative Abuse

Interventions

Type	Name	Description
DRUG	sodium oxybate, triazolam and pentobarbital	sodium oxybate, triazolam and pentobarbital

Timeline

• Start date: 2003-08-01
• Completion: 2005-03-01
• First posted: 2003-04-16
• Last updated: 2008-09-10

Locations

1 site across 1 country: United States