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

NCT03634917 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2024-05-29

No results posted yet for this study

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.

Conditions

  • Alcoholism

Interventions

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)

Sponsors & Collaborators

  • Technische Universität Dresden

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03634917 on ClinicalTrials.gov