Investigating how the septal nuclei in the brain relate to alcohol use disorder

Involvement of the Septal Nuclei of the Human Brain in Alcohol Use Disorder - a Functional Magnetic Resonance Imaging Study

This study is trying to see how certain parts of the brain are connected to alcohol use disorder by comparing brain activity in people with the disorder to those without it while they look at alcohol-related images.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 30 Years to 65 Years
• Sex: All
• Sponsor: Psychiatric Centre Rigshospitalet (Academic / other)
• Locations: 1 site (Frederiksberg)
• Trial ID: NCT06866379 on ClinicalTrials.gov

What this trial studies

This study aims to explore the role of the septal nuclei in the human brain concerning alcohol use disorder (AUD) by using functional MRI (fMRI) imaging. Participants diagnosed with AUD will be compared to those without the disorder while being shown alcohol-related images in an MRI scanner. The study will include a total of 50 participants, with 25 having AUD and 25 serving as controls. The fMRI scans will measure neural activity through the BOLD signal, providing insights into the neuro-anatomical mechanisms underlying addiction.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals diagnosed with alcohol use disorder according to DSM-5 criteria.

Not a fit: Patients with other substance use disorders or severe mental health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance our understanding of the brain mechanisms involved in alcohol addiction, potentially leading to improved treatment strategies.

How similar studies have performed: While studies have explored brain mechanisms in addiction, the specific focus on the septal nuclei in humans is relatively novel and under-researched.

Eligibility criteria

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

Where this trial is running

Frederiksberg

• Psychiatric Center Copenhagen, Frederiksberg Hospital — Frederiksberg, Denmark (Recruiting)

Study contacts

• Study coordinator: Mette K Klausen, MD, PhD

Conditions Alcohol Use Disorder; Alcohol use disorder; AUD; septum; fMRI; Brain imaging