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Clinical Trials in Denmark / NCT06866379
Recruiting Not applicable

Involvement of the Septal Nuclei of the Human Brain in Alcohol Use Disorder

NCT06866379 · tracked via the Priya Life Science Denmark tracker
Sponsor
Anders Fink-Jensen, MD, DMSci
Phase
Not applicable
Started
2025-05-07
Last updated
2025-06-11

Condition(s) studied

Alcohol Use Disorder

Investigational drug(s) / intervention(s)

Brain imaging

Brain imaging: fMRI session with the ALCUE paradigme.

Study summary

Alcohol activates reward systems in different brain areas, i.e., the nucleus accumbens, dorsal striatum, extended amygdala, and prefrontal cortex. These areas are all part of the reward neurocircuitry, which plays an important role in the development of addiction.

A former study performed on rodents has shown that a specific area of the forebrain, the septal nuclei, is associated with the feeling of reward and, hence, addiction when stimulated. However, whether the septal area is involved in reward and addiction in humans is sparsely investigated.

The purpose of this brain-imaging study is to assess how the septal nuclei react to alcohol-related pictures shown to participants diagnosed with alcohol use disorder while lying in an MRI scanner, compared to people without a diagnosis of alcohol use disorder. This might give us a better understanding of how the septal nuclei is involved in reward and addiction.

Eligibility

Sex
ALL
Min age
30 Years
Max age
65 Years
Healthy volunteers
No
Inclusion criteria: * Diagnosed with alcohol use disorder (AUD) according to DSM-5, and alcohol dependence according to ICD-10 * An Alcohol Use Disorder Identification Test (AUDIT) score ≥ 15 * At least six heavy drinking days for the last 30 days, measured with the Time Line Follow Back (TLFB) method Exclusion criteria: * Diagnosis of schizophrenia spectrum disorder, paranoid psychosis, bipolar disorder, or mental retardation * Previous or current substance use disorder other than AUD and nicotine use disorder * History of alcohol withdrawal seizures within the past 5 years * Alcohol withdrawal symptoms defined as a CIWA-Ar score \> 9 at screening or at the fMRI session * Treatment with chlordiazepoxide or other benzodiazepine within the past 30 days * Other pharmacological treatment for AUD within the past 30 days * Treatment with GLP-1 analogues within the last 6 months * Urine tests positive for psychoactive drugs (cocaine, amphetamine, TCH, methadone, opioids, and benzodiazepines) at screening * DUDIT score ≥ 2/6 for females/males * Contraindications for undergoing an fMRI scan (magnetic implants, metal splinters, pacemaker, claustrophobia, etc.) * Females of childbearing potential who are either pregnant, breastfeeding or have the intention of becoming pregnant within the next month or are not using contraception appropriate for participating in a clinical study * Pregnancy (positive urine pregnancy test) * Unable to speak or understand Danish * Any condition that the investigator feels would interfere with trial participation

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Psychiatric Center Copenhagen, Frederiksberg Hospital Frederiksberg Denmark Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06866379 on ClinicalTrials.gov ↗ ← All trials in Denmark