Involvement of the Septal Nuclei of the Human Brain in Alcohol Use Disorder
ConditionAlcohol Use Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-65
SponsorAnders Fink-Jensen, MD, DMSci
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Brain imaging
Other interventionfMRI session with the ALCUE paradigme.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Participants with AUDExperimental treatment 1 intervention
Trial outcomes
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).
Time frame
12 minutes while the brain scan is being conductedSecondary outcomes
1
Significant differences between AUD patients and healthy controls with respect to the subjectively reported craving degree
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)
Time frame
From beginning of the fMRI scan to the end of it at 12 minutes2
Significant differences between AUD patients and healthy controls with respect to alcohol cue related signals
The differences will be measured during the fMRI scan and analysed with BOLD-respons in putamen, caudate, nucleus accumbens and dorsal- and ventral striatum.
Time frame
From beginning of the fMRI scan to the end of it at 12 minutes3
Correlation between subjectively reported craving and BOLD signals
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
Time frame
From beginning of the fMRI scan to the end of it at 12 minutesSponsors and contacts
Click on the lead sponsor to view all of their trials.
Anders Fink-Jensen, MD, DMSci
Lead sponsor
Psychiatric Centre Rigshospitalet
Sponsor institution
Neurobiology Research Unit, Rigshospitalet
Collaborator
The foundation of Mr. Ivan Nielsen
Collaborator
King Christian X foundation
Collaborator
Source ClinicalTrials.gov