Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Alcoholism
Type
Interventional
Phase
Phase 3
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Care Provider, Investigator)Primary Purpose: Basic Science

Participation Requirements

Age
Between 25 years and 55 years
Gender
Both males and females

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 ...

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. 84 at least high risky drinkers (WHO) with at least mild alcohol use disorder perform two alcohol self-administration experiments, one before and one after 14-19 days of randomized double-blinded treatment with Acamprosate, Calcium Carbonate or Placebo. Each alcohol request requires prior work in a constant attention task according to a progressive schedule to earn the next alcohol infusion. Secondary objectives refer to investigations, whether administration of Acamprosate or Calcium Carbonate in comparison to placebo leads to a change in perception of subjective alcohol effects effectiveness of Acamprosate or Calcium can be predicted by calcium parameters (baseline and changes during medication period) administration of Acamprosate or Calcium leads to a reduction in alcohol craving Frequency of alcohol consumption during the imposed abstinence period differs between treatment groups and influences primary outcome study participation modifies motivation to change drinking habits and utilization of addiction care services Acid sphingomyelinase (ASM) activities are applicable as biomarker and predictor of medication effects. safety issues occur due to study medication

Tracking Information

NCT #
NCT03634917
Collaborators
Not Provided
Investigators
Not Provided