Investigation of the Efficacy of Acamprosate and Calcium in Comparison to Placebo as Validation of a Behavioural Test for Alcohol Dependence
Last updated on July 2021Recruitment
- 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