NCT03634917

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Technische Universität Dresden · Academic / Other
• Sex: All
• Age: 25 Years – 55 Years
• Healthy volunteers: Accepted

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.

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. 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

Conditions

• Alcoholism

Interventions

Type	Name	Description
DRUG	Acamprosate Calcium	1 capsule with 666 mg Acamprosate
DRUG	Calcium Carbonate	1 capsule with 1500 mg Calcium Carbonate
DRUG	Placebo	1 Capsule with Placebo (lactose monohydrate, micro crystalline cellulose, magnesium stearate)
DRUG	Placebo lead in	1 Capsule with Placebo (lactose monohydrate, micro crystalline cellulose, magnesium stearate)

Timeline

• Start date: 2020-08-05
• Primary completion: 2023-08-30
• Completion: 2024-05-01
• First posted: 2018-08-17
• Last updated: 2024-05-29

Locations

1 site across 1 country: Germany