Investigation of the Efficacy of Acamprosate & Calcium in Comparison to

Status Completed

Clinical Trial Summary

Validation of a Test System to develop new medications for alcoholism (TEMA) The 'TEMA', a progressive-work alcohol self-administration paradigm, can be validated by reproducing the effect of Acamprosate and prove the effect of Calcium to reduce motivation to work for alcohol after 14 - 19 days of treatment during a period of 15 - 20 days of alcohol abstinence in a randomized, double-blind, placebo-controlled three-arm parallel-group design.

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. 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 1. administration of Acamprosate or Calcium Carbonate in comparison to placebo leads to a change in perception of subjective alcohol effects 2. effectiveness of Acamprosate or Calcium can be predicted by calcium parameters (baseline and changes during medication period) 3. administration of Acamprosate or Calcium leads to a reduction in alcohol craving 4. Frequency of alcohol consumption during the imposed abstinence period differs between treatment groups and influences primary outcome 5. study participation modifies motivation to change drinking habits and utilization of addiction care services 6. Acid sphingomyelinase (ASM) activities are applicable as biomarker and predictor of medication effects. 7. safety issues occur due to study medication ;

Study Design

Related Conditions & MeSH terms

Alcoholism

Clinical Trial Details

NCT number	NCT03634917
Study type	Interventional
Source	Technische Universität Dresden
Contact
Status	Completed
Phase	Phase 3
Start date	August 5, 2020
Completion date	May 1, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Investigation of the Efficacy of Acamprosate and Calcium in Comparison to Placebo as Validation of a Behavioural Test for Alcohol Dependence — TEMACA

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms