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

Phase

N/A

Condition

Alcohol Dependence

Addictions

Alcohol Use Disorder

Treatment

Brain imaging

Clinical Study ID

NCT06866379

The septum study

Ages 30-65
All Genders

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 Criteria

Inclusion

Inclusion criteria:

Diagnosed with alcohol use disorder (AUD) according to DSM-5, and alcohol dependenceaccording 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 LineFollow Back (TLFB) method

Exclusion

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 thefMRI 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 theintention of becoming pregnant within the next month or are not using contraceptionappropriate 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

Study Design

Brain imaging

May 07, 2025

November 30, 2025

Study Description

This is a comparative, non-interventional, case-control, brain imaging study using the ALCUE paradigm to investigate the neuro-anatomical underpinings of AUD during a fMRI-scan. The contrast used for the fMRI scans is the BOLD signal which measures the ratio of oxygenated to deoxygenated blood in the brain as a measurement of neural activity.

The study will conclude after the last participant with AUD succesfully has undergone the fMRI scan, and will include 50 participants in total: 25 participants diagnosed with AUD and 25 participants without AUD (data from a previous brain imaging study). Written informed consent will be collected, before any trial activities are performed.

Connect with a study center

Psychiatric Center Copenhagen, Frederiksberg Hospital
Frederiksberg, 2000
Denmark
Active - Recruiting

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