Involvement of the Septal Nuclei of the Human Brain in Alcohol Use Disorder
Involvement of the Septal Nuclei of the Human Brain in Alcohol Use Disorder - a Functional Magnetic Resonance Imaging Study
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.
Study Overview
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mette K Klausen, MD, PhD
- Phone Number: 004524835004
- Email: mette.kruse.klausen@regionh.dk
Study Contact Backup
- Name: Anders Fink-Jensen, Professor
- Phone Number: 004538647070
- Email: anders.fink-jensen@regionh.dk
Study Locations
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Frederiksberg, Denmark, 2000
- Recruiting
- Psychiatric Center Copenhagen, Frederiksberg Hospital
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Contact:
- Mette K Klausen, MD, PhD
- Phone Number: 004524835004
- Email: mette.kruse.klausen@regionh.dk
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Contact:
- Anders Fink-Jensen, Professor
- Phone Number: 004538647070
- Email: anders.fink-jensen@regionh.dk
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Sub-Investigator:
- Linnea R Køber, Scholar student
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Participants with AUD
Participants diagnosed with alcohol use disorder participating in one fMRI brain scan.
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fMRI session with the ALCUE paradigme.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Significant differences in alcohol cue related fMRI BOLD signals in the septal nuclei of the brain between AUD patients and healthy controls.
Time Frame: 12 minutes while the brain scan is being conducted
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Data is obtained using the ALCUE fMRI paradigm with the septal area as a predefined region of interest (ROI).
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12 minutes while the brain scan is being conducted
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Significant differences between AUD patients and healthy controls with respect to the subjectively reported craving degree
Time Frame: From beginning of the fMRI scan to the end of it at 12 minutes
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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)
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From beginning of the fMRI scan to the end of it at 12 minutes
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Significant differences between AUD patients and healthy controls with respect to alcohol cue related signals
Time Frame: From beginning of the fMRI scan to the end of it at 12 minutes
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The differences will be measured during the fMRI scan and analysed with BOLD-respons in putamen, caudate, nucleus accumbens and dorsal- and ventral striatum.
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From beginning of the fMRI scan to the end of it at 12 minutes
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Correlation between subjectively reported craving and BOLD signals
Time Frame: From beginning of the fMRI scan to the end of it at 12 minutes
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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
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From beginning of the fMRI scan to the end of it at 12 minutes
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- The septum study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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