drugset / Trial / NCT03634917

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

NCT03634917

Phase 3 Completed 82 enrolled Technical University Dresden
RandomizedParallel-groupTriple-blindBasic science

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.

Timeline

Start
2020-08-05
Primary completion
2023-08-30
Completion
2024-05-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acamprosate Small molecule 666 mg Oral
Comparator Calcium carbonate Other / unclassified 1500 mg Oral

Indications