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

Not Applicable

Recruiting

• Conditions: Alcohol Use Disorder

• Registration Number: NCT06866379
• Lead Sponsor: Anders Fink-Jensen, MD, DMSci

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2025-03-04
• Study First Submitted QC: 2025-03-04
• Study First Posted: 2025-03-10
• Status Verified: 2025-04
• Study Start: 2025-05-07
• Last Update Submitted: 2025-06-10
• Last Update Posted: 2025-06-11
• Primary Completion: 2025-09-01
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Significant differences in alcohol cue related fMRI BOLD signals in the septal nuclei of the brain between AUD patients and healthy controls.	12 minutes while the brain scan is being conducted	Data is obtained using the ALCUE fMRI paradigm with the septal area as a predefined region of interest (ROI).

Secondary Outcome Measures

Name	Time	Method
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	The craving degree will be measured during the fMRI paradigm on a visual analogue scale ranging from 0 (no craving) to 100 (extremely extensive craving)
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	The differences will be measured during the fMRI scan and analysed with BOLD-respons in putamen, caudate, nucleus accumbens and dorsal- and ventral striatum.
Correlation between subjectively reported craving and BOLD signals	From beginning of the fMRI scan to the end of it at 12 minutes	A comparision between the subjectively measured craving degree using a visual analogue scale and the BOLD signals of the putamen, caudate, nucleus accumbens and dorsal- and ventral striatum measured during the fMRI

Trial Locations

Locations (1)

Psychiatric Center Copenhagen, Frederiksberg Hospital; 🇩🇰 Frederiksberg, Denmark