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Neuronal reactivity in men with high alcohol consumption after reduction of dihydrotestosterone in a pharmaco-challenge experiment with finasteride vs. placebo (Reduction of dihydrotestosterone and neuronal reactivity)

Neuronal reactivity in men with high alcohol consumption after reduction of dihydrotestosterone in a pharmaco-challenge experiment with finasteride vs. placebo (Reduction of dihydrotestosterone and neuronal reactivity) - ReD-Neuron

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00020569
Enrollment
50
Registered
2021-12-27
Start date
2022-02-14
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuronal reactivity

Interventions

Group 1: Finasteride 5mg (one-time administration) Group 2: Placebo (one-time administration)

Sponsors

Zentralinstitut für Seelische Gesundheit (ZI)
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Body mass index 18.5-30.0 kg/m²; high episodic alcohol consumption defined as drinking at least 5 alcoholic beverages of 12 g alcohol each (12 g alcohol is equivalent to approximately 0.33 liters of beer or approximately 0.125 liters of wine) on one occasion, i.e., within a few hours, once per month (WHO, 2018); ability to give written informed consent and to undergo fMRI; present written informed consent; sufficient knowledge of the German language; breath alcohol concentration of 0.0 per mille

Exclusion criteria

Exclusion criteria: Lack of written informed consent; medical history with outpatient or inpatient treatment of depressive or bipolar disorder, psychotic disorder, schizophrenia or schizophrenic spectrum disorder, or substance dependence other than alcohol, nicotine or cannabis; medical history of severe head injury or other severe central nervous system disease (e.g., dementia, Parkinson's disease, multiple sclerosis); use of drugs or medications that interact with the central nervous system within the past 10 days or if their use was less than 5 half-lives ago; regular use of finasteride for medical reasons; exclusion criteria for finasteride use: known hypersensitivity to finasteride, clinically significant pharmacokinetic interaction (finasteride is metabolized via the cytochrome P450-3A4 system), currently planning pregnancy with sexual intercourse without contraception, pregnant partner; exclusion criteria for an MRI examination (e.g. metal in the body)

Design outcomes

Primary

MeasureTime frame
Neuronal fMRI reactivity to alcohol stimuli

Secondary

MeasureTime frame
Neuronal reactivity to emotional stimuli, in a stop signal task, in an incentive delay task, explicit and implicit craving, and attention bias

Countries

Germany

Contacts

Public ContactRafat Boroumand-Jazi

Zentralinstitut für Seelische Gesundheit (ZI)

rafat.boroumandjazi@zi-mannheim.de++49 621 1703 3522

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026