Validation of a Test System for Development of Medications for Alcoholism — TEMANX  

Alcoholism Clinical Trial

Official title: Validation of a Test System for Development of Medications for Alcoholism

Status Completed

Clinical Trial Summary

Using theTEMA (test system for development of medications for alcoholism) it can be shown, that naltrexone administration reduces the willingness to perform work for alcohol infusion in a laboratory experiment.

Clinical Trial Description

Objective of this study is to show that a laboratory alcohol self-administration method can predict the therapeutic potential of new compounds to reduce relapse in alcohol-dependent patients.

The 'TEMA" translates several animal behavioral paradigms of alcohol self-administration into corresponding human experiments.

We will investigate the opiate antagonist Naltrexone, whose anti-relapse effect is well documented, as a reference drug for validation.

Main objective:

With TEMA (test system for development of medications for alcoholism ) it can be shown, that naltrexone administration reduces the willingness to perform work for alcohol infusion in a laboratory experiment.

Secondary objectives:

• administration of naltrexone in comparison to placebo leads to a reduction of alcohol craving and real-life drinking

• administration of naltrexone in comparison to placebo leads to reduction of the CDT-Level

• administration of naltrexone in comparison to placebo leads to a change in perception of subjective alcohol effects

• the effectiveness of naltrexone can be predicted by the A118G polymorphism of the OPRM1

• administration of naltrexone changes the baseline and alcohol-induced ability of motor inhibition

• administration of naltrexone changes the baseline and alcohol-induced regional cerebral perfusion

• administration of naltrexone changes the baseline and alcohol-induced cerebral resting state activity

• changes of alcohol effects to the brain activity induced by naltrexone in comparison to placebo correlate with effects of naltrexone on the willingness to work for alcohol self-administration ;

Related Conditions & MeSH terms

• Alcoholism

• NCT number: NCT02652585
• Study type: Interventional
• Source: Technische Universität Dresden
• Status: Completed
• Phase: Phase 3
• Start date: February 2016
• Completion date: September 4, 2017