Investigation of the efficacy of acamprosate and calcium in comparison to placebo as validation of a behavioural test for alcohol dependence (TEMACA)
Funded by BMBF grant 01ZX1611H
Project Summary
The clinical trial (EudraCT number 2018-001386-16; TUD-TEMACA-069) aims to evaluate the efficacy of acamprosate and ionized calcium in reducing the willingness to work for alcohol in participants diagnosed with alcohol use disorder in a laboratory test system.
The trial employs the 'human laboratory test system to screen new medications for alcoholism' (TESMA) to examine the effects of these substances on behavioral changes within a controlled laboratory environment. It aims to validate the TESMA as an effective system for evaluating potential new treatments targeting alcohol use disorder.
In the first funding period, the effects of naltrexone on the behavior of non-dependent but at least medium risk drinkers were investigated under different contingencies of alcohol reinforcement. The unique experimental design allowed both positive and potentially negative reinforcement to be modeled in a single experiment (Spreer et al 2023).
Project Members
Michael Smolka (PI)
Maik Spreer (Researcher and Physician)
Collaborators
Manufacturer of the investigational medicinal products:
Dr. I--M. Klut, Clinic Pharmacy of the University Hospital Carl Gustav Carus Dresden
Laboratories:
Institute for Clinical Chemistry and Laboratory Medicine of the University Hospital Carl Gustav Carus Dresden
Dr. rer.nat. Michael Böttcher
MVZ Labor Dessau GmbH
Dr. rer.nat. Christiane Mühle
Laboratory for Molecular Neurobiology of the PSychiatric and Psyhotherapeutic Clinic of the University Hospital Erlangen
Data management:
Stephan Friedrich
Control Center for Clinical Trials (KKS) Dresden
Clinical monitoring:
Dr. Jette Rahn
Control Center for Clinical Trials (KKS) Dresden
Pharmacovigilance:
Barabara Djawid
Control Center for Clinical Trials (KKS) Dresden
Biometrics:
Cathrin Sauer
Clinic and Polyclinic for Psychiatriy and Psychotherapy, University Hospital Carl Gustav Carus Dresden
Key Publications:
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Spreer M, Grahlert X, Klut IM, Al Hamdan F, Sommer WH, Plawecki MH, O'Connor S, Bottcher M, Sauer C, Smolka MN & Zimmermann US (2023) Using naltrexone to validate a human laboratory test system to screen new medications for alcoholism (tesma)- a randomized clinical trial. Transl Psychiatry 13(1):113. https://doi.org/10.1038/s41398-023-02404-7
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Fang X, Deza-Araujo YI, Petzold J, Spreer M, Riedel P, Marxen M, O'Connor SJ, Zimmermann US & Smolka MN (2021) Effects of moderate alcohol levels on default mode network connectivity in heavy drinkers. Alcohol Clin Exp Res 45(5):1039-50. https://doi.org/10.1111/acer.14602
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Riedel P, Wolff M, Spreer M, Petzold J, Plawecki MH, Goschke T, Zimmermann US & Smolka MN (2021) Acute alcohol does not impair attentional inhibition as measured with stroop interference scores but impairs stroop performance. Psychopharmacology (Berl) 238(6):1593-607. https://doi.org/10.1007/s00213-021-05792-0