Alcohol Use DisorderNIQANCT05843435
Brain Connectivity Between Networks Implied in Inhibition and Cue-reactivity in Alcohol Use Disorder
An observational study of Alcohol Use Disorder, run by University of Bern at 1 site in Switzerland.
Trial summary
Research about patients with alcohol use disorder has shown that task-related brain activation patterns as well as resting-state connectivity (measured with functional magnetic resonance imaging) change with clinical parameters such as the extent of craving and duration of abstinence during treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Go-Nogo-task during functional magnetic resonance imaging and Resting-state functional magnetic resonance imaging
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 59 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 May 2024to 31 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: AUD patients are detoxified and will be recruited upon entry to specialized residential treatment program at the Clinic Südhang in Kirchlindach in Switzerland. HC subjects will be recruited via advertisement in social media and local newspapers in the area of Bern in Switzerland.
Who may be able to join
- Abstained from alcohol for at least 4 weeks prior to fMRI measurement (AUD only)
- Diagnosis of AUD according to ICD-11 (AUD only)
- Written informed consent
- Mother tongue German (or Swiss German)
- Right-handedness
- AUDIT ≤ 7 (HC only)
Show all 9Show fewer
- AUD-S < 2 (HC only)
- BSCL GSI ≤ 63 (T-value, HC only)
- DUDIT < 7 (HC only)
Who cannot join
- Other main psychiatric diagnosis than AUD (comorbidity allowed, but AUD has to be considered the main diagnosis, AUD only)
- Neurocognitive problems
- Current medical conditions excluding participation (e.g. acute infectious disease)
- Inability to understand the participant information
- Contraindication to Magnetic Resonance Imaging (e.g. metallic objects, pregnancy, claustrophobia)
- History of alcohol and other substance use disorder (HC only)
- Being staff or student of the project leader and other persons involved in the project
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital for Psychiatry and Psychotherapy Bern
Bern, 3000
About this study
Research about patients with alcohol use disorder has shown that task-related brain activation patterns as well as resting-state connectivity (measured with functional magnetic resonance imaging) change with clinical parameters such as the extent of craving and duration of abstinence during treatment. These brain activation alterations are related to treatment success. Although an imbalance between increased cue-reactivity and impaired counteracting inhibitory control processes are at the core of most neuropsychological conceptualizations of alcohol use disorder, the direct interaction between these two processes has not yet been investigated. Therefore, the investigators aim to study patients with alcohol use disorder in an ultra-high-field 7 Tesla magnetic resonance imaging scanner to identify fine-grained activation and connectivity patterns. The investigators would like to improve the knowledge of the interplay between the brain networks for inhibition and cue-reactivity, as well as to explore its influence on craving and treatment success. The investigators hypothesize that a more pronounced negative relationship between increased cue-reactivity and reduced inhibitory control processes in the brain is linked to higher craving and worse relapse probability.
Read the detailed description
Even if an imbalance between enhanced cue-reactivity and impaired opposing control processes is at the center of most neuroscientific conceptualizations of alcohol use disorder (AUD), these two processes are still rarely investigated in direct interaction.
Attempting to target both processes in one design, initial studies reported enhanced brain activation in anterior cingulate cortex (ACC) and ventrolateral prefrontal cortex (vlPFC), when control processes had to be carried out in the context of alcohol-related cues, and linked this altered brain activation to relapse risk. Hence, the proposed study will take advantage of the higher spatial resolution and signal-to-noise ratio of a 7 Tesla fMRI scanner to investigate more subtle effects and the involvement of subregions of vlPFC and ACC during alcohol-related inhibition.
Of special interest, particularly when it comes to explaining an imbalance between brain systems related to cue-reactivity and inhibitory control, are concurrent measures of functional brain connectivity. Aberrant resting-state functional connectivity in networks involved in reward prediction, motivation, salience attribution and executive control have been reported in AUD. Also, altered task-related connectivity was observed during cue-reactivity as well as during executive control. However, functional connectivity measures during a task combining both aspects are still missing. Therefore, this study examines the mutual interplay between cue-responsive regions and opposing inhibitory control networks. To this aim, task-related functional connectivity are measured in a specifically tailored experimental design allowing for the assessment of effects related to cue-reactivity, inhibition, as well as their interaction.
Besides, this study assesses whether possible interaction effects of task-related functional connectivity between cue-reactivity and inhibitory control vary with craving, change with prolonged abstinence or predicts drinking outcome.
Taken together, this study will deepen the understanding of the interplay between neuronal networks central to AUD, cue-reactivity and inhibitory control. The (im)balance between these processes is crucial for recently abstinent patients striving to control drinking habits and urges in an environment infused with alcohol-related cues. As such, markers capturing the interaction between these processes are of high conceptual and clinical relevance and might pave the way towards a potential biomarker indicating enhanced relapse risk.
- Conditions
- Alcohol Use Disorder
- Being tested
- Go-Nogo-task during functional magnetic resonance imaging, Resting-state functional magnetic resonance imaging
- Keywords
- Inhibition, Psychology, Magnetic Resonance Imaging, Drinking Behavior
- Medical subject headings
- Alcoholism, Inhibition, Psychological, Drinking Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Go-Nogo-task during functional magnetic resonance imagingBehavioural
Also called Siemens Terra 7T
Go-Nogo-task (GNG) implemented as a mixed block- and event-related design paradigm for task-related functional resonance imaging. It is composed of six blocks, each containing an event-related inhibitory control GNG. There are two blocks with an alcohol-related GNG, two blocks with a neutral GNG, and two blocks with a mixed GNG paradigm. The blocks are presented in a counterbalanced fashion between the participants. Each block contains 125 Go-trials and 25 NoGo-trials (ratio 5:1), resulting in 150 trials per block with a block time of 5 minutes. Participants are instructed to press a button whenever a stimulus appears on the screen (Go-trial). The only exception to this rule is when the same stimulus appears twice (NoGo-trial). Stimulus material consists of 60 alcohol-related and 60 neutral pictures, presented in a pseudo-randomized order.
Resting-state functional magnetic resonance imagingOther
An fMRI (multiband-echo-planar imaging) blood oxygenated level dependent (BOLD) protocol is run during 6 minutes of rest. This protocol allows the assessment of connectivity measures at rest, which can be compared to connectivity changes during the GNG task.
| Study group | Role | What they receive |
|---|---|---|
| Alcohol Use Disorder/AUD | A group of 30 detoxified patients who are part of the specialized residential treatment program at the Clinic Suedhang in Kirchlindach in Switzerland. Receives: Behavioral: Go-Nogo-task during functional magnetic resonance imaging; Other: Resting-state functional magnetic resonance imaging | |
| Healthy Controls/HC | A group of 30 age- and gender-matched healthy control subjects who are recruited via advertisement in social media or local newspaper. Receives: Behavioral: Go-Nogo-task during functional magnetic resonance imaging; Other: Resting-state functional magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOLD contrast alcohol vs. neutral inhibition
The BOLD signal (spatial activation pattern) of alcohol-related stimuli and neutral stimuli during successful inhibition is compared between AUD and HC.
Measured: 3-4 weeks after study inclusion
BOLD contrast covariance with craving
Covariance analysis of the BOLD contrast of successful inhibition between alcohol-related stimuli and neutral stimuli with measures of craving (obsessive compulsive drinking scale, visual analogue scale of craving)
Measured: 3-4 weeks after study inclusion
Secondary outcomes (2)
BOLD task-related connectivity
Psychophysiological interaction (PPI) derived functional connectivity strengths (voxel-to-voxel correlations stratified for cue-type, alcohol vs. neutral), assessing of main effects related to cue-reactivity (alcohol vs. neutral), inhibition (Nogo vs. Go), as well as their interaction and difference between AUD and HC.
Measured: 3-4 weeks after study inclusion
BOLD task-related connectivity covariance with craving and drinking outcome
Covariance of craving (obsessive compulsive drinking scale, visual analogue scale of craving) and drinking outcome measures (difference in percentage of days abstinent between baseline and 3-month follow-up) with BOLD connectivity of cue-reactivity and inhibitory control.
Measured: 3 months after GNG-task in fMRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 May 2024
- Primary completion13 Oct 2025
- Study completion31 Oct 2025
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.
- More trials run by University of BernThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Clinic Suedhang
- Responsible party
- Sponsor
- Investigators
- Matthias Grieder, PhD, Principal investigator, University Hospital for Psychiatry and Psychotherapy Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843435
- Sponsor's protocol ID
- 2023-00736
- Other IDs
- 2023
- Acronym
- NIQA
- Status last verified
- Nov 2025
- First submitted
- 24 Apr 2023
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Connectivity Between Networks Implied in Inhibition and Cue-reactivity in Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT05843435
- Acronym / sponsor ID
- NIQA / 2023-00736
- Conditions
- Alcohol Use Disorder
- Keywords
- Inhibition, Psychology, Magnetic Resonance Imaging, Drinking Behavior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Collaborators
- Clinic Suedhang
- Study start
- 1 May 2024 (actual)
- Primary completion
- 13 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 6 May 2023 (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.
Research about patients with alcohol use disorder has shown that task-related brain activation patterns as well as resting-state connectivity (measured with functional magnetic resonance imaging) change with clinical parameters such as the extent of craving and duration of abstinence during treatment. These brain activation alterations are related to treatment success. Although an imbalance between increased cue-reactivity and impaired counteracting inhibitory control processes are at the core of most neuropsychological conceptualizations of alcohol use disorder, the direct interaction between these two processes has not yet been investigated. Therefore, the investigators aim to study patients with alcohol use disorder in an ultra-high-field 7 Tesla magnetic resonance imaging scanner to identify fine-grained activation and connectivity patterns. The investigators would like to improve the knowledge of the interplay between the brain networks for inhibition and cue-reactivity, as well as to explore its influence on craving and treatment success. The investigators hypothesize that a more pronounced negative relationship between increased cue-reactivity and reduced inhibitory control processes in the brain is linked to higher craving and worse relapse probability.
Detailed description
Even if an imbalance between enhanced cue-reactivity and impaired opposing control processes is at the center of most neuroscientific conceptualizations of alcohol use disorder (AUD), these two processes are still rarely investigated in direct interaction.
Attempting to target both processes in one design, initial studies reported enhanced brain activation in anterior cingulate cortex (ACC) and ventrolateral prefrontal cortex (vlPFC), when control processes had to be carried out in the context of alcohol-related cues, and linked this altered brain activation to relapse risk. Hence, the proposed study will take advantage of the higher spatial resolution and signal-to-noise ratio of a 7 Tesla fMRI scanner to investigate more subtle effects and the involvement of subregions of vlPFC and ACC during alcohol-related inhibition.
Of special interest, particularly when it comes to explaining an imbalance between brain systems related to cue-reactivity and inhibitory control, are concurrent measures of functional brain connectivity. Aberrant resting-state functional connectivity in networks involved in reward prediction, motivation, salience attribution and executive control have been reported in AUD. Also, altered task-related connectivity was observed during cue-reactivity as well as during executive control. However, functional connectivity measures during a task combining both aspects are still missing. Therefore, this study examines the mutual interplay between cue-responsive regions and opposing inhibitory control networks. To this aim, task-related functional connectivity are measured in a specifically tailored experimental design allowing for the assessment of effects related to cue-reactivity, inhibition, as well as their interaction.
Besides, this study assesses whether possible interaction effects of task-related functional connectivity between cue-reactivity and inhibitory control vary with craving, change with prolonged abstinence or predicts drinking outcome.
Taken together, this study will deepen the understanding of the interplay between neuronal networks central to AUD, cue-reactivity and inhibitory control. The (im)balance between these processes is crucial for recently abstinent patients striving to control drinking habits and urges in an environment infused with alcohol-related cues. As such, markers capturing the interaction between these processes are of high conceptual and clinical relevance and might pave the way towards a potential biomarker indicating enhanced relapse risk.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcohol Use Disorder/AUD | – | Behavioral: Go-Nogo-task during functional magnetic resonance imaging, Other: Resting-state functional magnetic resonance imagingA group of 30 detoxified patients who are part of the specialized residential treatment program at the Clinic Suedhang in Kirchlindach in Switzerland. |
| Healthy Controls/HC | – | Behavioral: Go-Nogo-task during functional magnetic resonance imaging, Other: Resting-state functional magnetic resonance imagingA group of 30 age- and gender-matched healthy control subjects who are recruited via advertisement in social media or local newspaper. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- AUD patients are detoxified and will be recruited upon entry to specialized residential treatment program at the Clinic Südhang in Kirchlindach in Switzerland. HC subjects will be recruited via advertisement in social media and local newspapers in the area of Bern in Switzerland.
Key inclusion criteria (9 listed)
- Abstained from alcohol for at least 4 weeks prior to fMRI measurement (AUD only)
- Diagnosis of AUD according to ICD-11 (AUD only)
- Written informed consent
- Mother tongue German (or Swiss German)
- Right-handedness
Key exclusion criteria (7 listed)
- Other main psychiatric diagnosis than AUD (comorbidity allowed, but AUD has to be considered the main diagnosis, AUD only)
- Neurocognitive problems
- Current medical conditions excluding participation (e.g. acute infectious disease)
- Inability to understand the participant information
- Contraindication to Magnetic Resonance Imaging (e.g. metallic objects, pregnancy, claustrophobia)
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 |
|---|---|---|
| Go-Nogo-task during functional magnetic resonance imagingAlso: Siemens Terra 7TGo-Nogo-task (GNG) implemented as a mixed block- and event-related design paradigm for task-related functional resonance imaging. It is composed of six blocks, each containing an event-related inhibitory control GNG. There are two blocks with an alcohol-related GNG, two blocks with a neutral GNG, and two blocks with a mixed GNG paradigm. The blocks are presented in a counterbalanced fashion between the participants. Each block contains 125 Go-trials and 25 NoGo-trials (ratio 5:1), resulting in 150 trials per block with a block time of 5 minutes. Participants are instructed to press a button whenever a stimulus appears on the screen (Go-trial). The only exception to this rule is when the same stimulus appears twice (NoGo-trial). Stimulus material consists of 60 alcohol-related and 60 neutral pictures, presented in a pseudo-randomized order. | Behavioural | Alcohol Use Disorder/AUD, Healthy Controls/HC |
| Resting-state functional magnetic resonance imagingAn fMRI (multiband-echo-planar imaging) blood oxygenated level dependent (BOLD) protocol is run during 6 minutes of rest. This protocol allows the assessment of connectivity measures at rest, which can be compared to connectivity changes during the GNG task. | Other | Alcohol Use Disorder/AUD, Healthy Controls/HC |
Primary outcome
BOLD contrast alcohol vs. neutral inhibition
Time frame: 3-4 weeks after study inclusion
The BOLD signal (spatial activation pattern) of alcohol-related stimuli and neutral stimuli during successful inhibition is compared between AUD and HC.
BOLD contrast covariance with craving
Time frame: 3-4 weeks after study inclusion
Covariance analysis of the BOLD contrast of successful inhibition between alcohol-related stimuli and neutral stimuli with measures of craving (obsessive compulsive drinking scale, visual analogue scale of craving)
2 secondary outcomes
BOLD task-related connectivity
Time frame: 3-4 weeks after study inclusion
BOLD task-related connectivity covariance with craving and drinking outcome
Time frame: 3 months after GNG-task in fMRI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Matthias Grieder, PhD principal investigator
University Hospital for Psychiatry and Psychotherapy Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Use Disorder, run by University of Bern at 1 site in Switzerland.
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 9 inclusion and 7 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: finished, as of the sponsor's last update on 25 Nov 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOLD contrast alcohol vs. neutral inhibition (time frame: 3-4 weeks after study inclusion). The study lists 2 primary outcomes in all. 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 25 Nov 2025.