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

NCT06866379 | Recruiting

• 1 other identifier: The septum study
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcohol Use Disorder

Keywords

Alcohol use disorder; AUD; septum; fMRI; Brain imaging

Outcome Measures

Primary Outcomes (1)

• Significant differences in alcohol cue related fMRI BOLD signals in the septal nuclei of the brain between AUD patients and healthy controls.

  Data is obtained using the ALCUE fMRI paradigm with the septal area as a predefined region of interest (ROI).

  12 minutes while the brain scan is being conducted

Secondary Outcomes (3)

• Significant differences between AUD patients and healthy controls with respect to the subjectively reported craving degree

  From beginning of the fMRI scan to the end of it at 12 minutes

• Significant differences between AUD patients and healthy controls with respect to alcohol cue related signals

  From beginning of the fMRI scan to the end of it at 12 minutes

• Correlation between subjectively reported craving and BOLD signals

  From beginning of the fMRI scan to the end of it at 12 minutes

Study Arms (1)

Participants with AUD

EXPERIMENTAL

Participants diagnosed with alcohol use disorder participating in one fMRI brain scan.

Other: Brain imaging

Interventions

Brain imaging OTHER

fMRI session with the ALCUE paradigme.

Participants with AUD

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anders Fink-Jensen, MD, DMSci: lead
• Neurobiology Research Unit, Rigshospitalet: collaborator
• The foundation of Mr. Ivan Nielsen: collaborator
• King Christian X foundation: collaborator

Study Sites (1)

Psychiatric Center Copenhagen, Frederiksberg Hospital

Frederiksberg, 2000, Denmark

RECRUITING

MeSH Terms

Conditions

Alcoholism

Interventions

Neuroimaging

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Investigative Techniques

Central Study Contacts

Mette K Klausen, MD, PhD

CONTACT

004524835004; mette.kruse.klausen@regionh.dk

Anders Fink-Jensen, Professor

CONTACT

004538647070; anders.fink-jensen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Senior Consultant, dr.med.

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 10, 2025
• Study Start: May 7, 2025
• Primary Completion: September 1, 2025
• Study Completion: November 30, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-04

Locations

DK (1)