NCT02652585

Validation of a Test System for Development of Medications for Alcoholism

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Technische Universität Dresden · Academic / Other
• Sex: All
• Age: 25 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• Alcoholism

Interventions

Type	Name	Description
DRUG	Naltrexone
DRUG	Placebo	capsule filled with micro crystalline cellulose, manufactured to mimic naltrexone capsule

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-08-25
• Completion: 2017-09-04
• First posted: 2016-01-12
• Last updated: 2017-09-27

Locations

1 site across 1 country: Germany