Physiological, Behavioral and Subjective Effects of Drugs (GHB)

12:48 EDT 30th June 2015 | BioPortfolio

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.

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 Design

Allocation: Non-Randomized, Control: Placebo Control, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Sedative Abuse

Intervention

sodium oxybate, triazolam and pentobarbital

Location

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

Status

Completed

Source

Orphan Medical

Results (where available)

View Results

Links

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Medical and Biotech [MESH] Definitions

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