Alcohol Use DisorderNCT06866379
Involvement of the Septal Nuclei of the Human Brain in Alcohol Use Disorder
A study testing Brain imaging in people with Alcohol Use Disorder, run by Anders Fink-Jensen, MD, DMSci at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Brain imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- 7 May 2025to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Psychiatric Center Copenhagen, Frederiksberg Hospital
Frederiksberg, 2000
Anders Fink-Jensen, Professor, 004538647070, anders.fink-jensen@regionh.dk
Mette K Klausen, MD, PhD, 004524835004, mette.kruse.klausen@regionh.dk
About this study
Official title: 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.
Read the 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.
- Conditions
- Alcohol Use Disorder
- Being tested
- Brain imaging
- Keywords
- Alcohol use disorder, AUD, septum, fMRI, Brain imaging
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain imagingOther
fMRI session with the ALCUE paradigme.
| Study group | Role | What they receive |
|---|---|---|
| Participants with AUD | Experimental | Participants diagnosed with alcohol use disorder participating in one fMRI brain scan. Receives: Other: Brain imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 minutes while the brain scan is being conducted
Secondary outcomes (3)
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)
Measured: From beginning of the fMRI scan to the end of it at 12 minutes
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.
Measured: From beginning of the fMRI scan to the end of it at 12 minutes
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
Measured: From beginning of the fMRI scan to the end of it at 12 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start7 May 2025
- Primary completion1 Sep 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anders Fink-Jensen, MD, DMSci
- Sponsor type
- University, hospital or other
- Collaborators
- Neurobiology Research Unit, Rigshospitalet, The foundation of Mr. Ivan Nielsen, King Christian X foundation
- Responsible party
- Sponsor-investigator, Anders Fink-Jensen, MD, DMSci, Psychiatric Centre Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866379
- Sponsor's protocol ID
- The septum study
- Status last verified
- Apr 2025
- First submitted
- 4 Mar 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Involvement of the Septal Nuclei of the Human Brain in Alcohol Use Disorder - a Functional Magnetic Resonance Imaging Study
- ClinicalTrials.gov ID
- NCT06866379
- Acronym / sponsor ID
- The septum study
- Conditions
- Alcohol Use Disorder
- Keywords
- Alcohol use disorder, AUD, septum, fMRI, Brain imaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Anders Fink-Jensen, MD, DMSciUniversity, hospital or other
- Collaborators
- Neurobiology Research Unit, Rigshospitalet, The foundation of Mr. Ivan Nielsen, King Christian X foundation
- Study start
- 7 May 2025 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with AUD | Experimental | Other: Brain imagingParticipants diagnosed with alcohol use disorder participating in one fMRI brain scan. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain imagingfMRI session with the ALCUE paradigme. | Other | Participants with AUD |
Primary outcome
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
Data is obtained using the ALCUE fMRI paradigm with the septal area as a predefined region of interest (ROI).
3 secondary outcomes
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
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
Correlation between subjectively reported craving and BOLD signals
Time frame: From beginning of the fMRI scan to the end of it at 12 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain imaging in people with Alcohol Use Disorder, run by Anders Fink-Jensen, MD, DMSci at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mette K Klausen, MD, PhD (004524835004, mette.kruse.klausen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.