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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Psychiatric Center Copenhagen, Frederiksberg Hospital
  Frederiksberg, Denmark Recruiting

Study contacts

• Study coordinator: Mette K Klausen, MD, PhD
• Email: mette.kruse.klausen@regionh.dk
• Phone: 004524835004

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.