Alcohol AbuseNeuStressNCT06247306
Using Neurofeedback to Understand the Relationship Between Stress and Alcohol Consumption
A study testing ScanSTRESS fMRI-paradigm (Streit et al., 2014) and real-time fMRI neurofeedback in people with Alcohol Abuse and Craving, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
Trial summary
In this research project, the aim is to discover the role specific brain networks play in the relationship between stress reactions and the desire for alcohol and alcohol consumption. To investigate this question, various brain imaging methods as well as cognitive tasks are combined. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Abuse, Craving, Psychosocial Stressor
- What is being tested?
- ScanSTRESS fMRI-paradigm (Streit et al., 2014) and real-time fMRI neurofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2024to 1 Jul 2027
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- Presence of 2 to a maximum of 5 criteria for alcohol use disorder according to DSM-5
- no clinical necessity for detoxification treatment
- participants may have a moderate cannabis use disorder and tobacco use disorder
- Capacity for consent and ability to use self-assessment scales
- Sufficient knowledge of German
- Willingness to use a mobile phone with Android operating system
Who cannot join
- Lifetime diagnosis of bipolar or psychotic disorder or a substance use disorder according to Diagnostical and Statistical Manual of Mental Disorders - 5 (DSM-5) that is not alcohol, cannabis, or tobacco use disorder
- Current substance use other than cannabis and tobacco
- Current diagnosis of one of the following conditions according to DSM-5: (hypo)manic episode, major depression, generalized anxiety disorder, post-traumatic stress disorder, borderline personality disorder, or obsessive-compulsive disorder
- History of severe head trauma or other severe central neurological disorders (dementia, Parkinson\'s disease, multiple sclerosis)
- Pregnancy or lactation
- Use of medications known to interact with the central nervous system within the last 10 days; testing at least four half-lives after the last dose
- Exercising the prerogative of the \"Right not to know\" in the context of incidental findings during an examination or investigation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Central Institute of Mental Health - Department of Clinical Psychology
Mannheim, Baden-Wurttemberg, 68159
Martin F Gerchen, PhD, +49-621/1703 ext. 6163, martin.gerchen@zi-mannheim.de
Nina J Kempf, M. Sc.
About this study
Official title: Probing the Influence of Neural Stress Responses on Problematic Alcohol Use With Real-time fMRI Neurofeedback (C04)
In this research project, the aim is to discover the role specific brain networks play in the relationship between stress reactions and the desire for alcohol and alcohol consumption. To investigate this question, various brain imaging methods as well as cognitive tasks are combined. Various questionnaires are sampled and brain scans are conducted.
Individuals interested in participating in the study have to fulfill certain criteria...
Read more
- no serious medical or mental health diagnosis
- problematic alcohol drinking habits
- interested in improving drinking habits ...and undergo various non-invasive procedures
- filling out several questionnaires concerning personality and habits
- undergoing a mental performance task while being in a brain scanner (MRI)
- attempting to regulate their own brain activity while lying in the MRI scanner
- filling out an electronic diary for 6 weeks - concerning daily mood, stress, and alcohol habits
Participants will be randomly allocated to either one of 2 experimental groups. Both groups undergo the same tasks, receive the same instructions and only differ regarding some aspects of the brain self-regulation task .
Read the detailed description
While it is well known and long acknowledged in scientific research that stress and alcohol consumption are closely linked, the actual relationship is complex, and the underlying mechanisms are only partially understood. To investigate the effects of acute stress under controlled conditions, experimental procedures, stress tests, and related paradigms are often employed. Studies on alcohol addiction generally indicate an increase in acute cravings following the experimental induction of stress. Neurologically, acute stress induction is associated with activation changes in widespread networks. In particular, research employing stress tests found increased activations in striatum, thalamus and limbic areas and deactivations in anterior cingulate cortex (ACC) as well as ventromedial prefrontal cortex (vmPFC), areas often associated with emotion regulation during stress induction. Given their role in emotion regulation, deactivations in these areas could reflect a reduction in emotional control during acute stress. Deactivation of these areas during experimentally induced stress has also been linked to problematic alcohol consumption and increased alcohol cravings.
This study aims to elucidate how neurocognitive processes during stress influence alcohol cravings and consumption. To this end, participants with problematic alcohol consumption will be recruited. After having filled out various questionnaires pertaining to their biographical data, alcohol consumption and personality traits, participants will be experimentally stressed during a brain scan using functional Magnetic Resonance Imaging (fMRI). To reliably induce psychosocial stress, the ScanSTRESS test, a paradigm explicitly conceptualized for usage during MRI scanning, will be employed. Once the stress test is completed, participants will attempt to regulate their own neurological stress response through upregulation of the ACC using information about their current stress-induced brain activity (neurofeedback). Additionally, saliva samples will be regularly taken during the experiment to biologically observe the stress response through cortisol measurements. This will be followed by a 6-week follow-up phase, during which participants will be specifically asked about their alcohol cravings, alcohol consumption, and daily stress experiences.
By employing real-time fMRI neurofeedback, this study creates experimental conditions in which participants can self-regulate the neural stress response of the targeted brain network. Nonspecific effects of the neurofeedback paradigm are controlled using a sham condition (Yoke-control group). Participants are randomly assigned to either the control group or the real neurofeedback group (experimental group). This approach allows for the investigation of the neural self-regulation abilities of emotional control networks and their role in the connection between stress, alcohol cravings, and drinking behavior in real life.
In summary, this study aims to examine the relationship between the self-regulation abilities of neural stress responses and real-life drinking behavior.
Investigators hypothesize that 1) the stress experiment significantly increases acute self-reported stress in participants, 2) specifically stress-induced patterns of neural activity, namely increased striatal and thalamic activity as well as decreased ACC activity, predict alcohol cravings and consumption, 3) the experimental neurofeedback group exhibits higher ACC activity during brain self-regulation than the control group, 4) the experimental group shows lower alcohol craving/consumption during the follow-up phase.
- Conditions
- Alcohol Abuse, Craving, Psychosocial Stressor, Neural Stress Response
- Being tested
- ScanSTRESS fMRI-paradigm (Streit et al., 2014), real-time fMRI neurofeedback
- Keywords
- functional Magnetic Resonance Imaging (fMRI), psychosocial stress, real-time fMRI neurofeedback (rtfMRI neurofeedback), problematic alcohol use, cortisol, Ecological momentary assessment (EMA)
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScanSTRESS fMRI-paradigm (Streit et al., 2014)Behavioural
The task is conducted within the MRI scanner and consists of two runs each lasting 11:20 mins., employs a block design and has two different conditions (performance, relaxation), as well as two different task within each condition. Participants undergo the following 2 tasks during the performance condition under time pressure: 1) serial subtraction, 2) a figure matching task. During the performance condition, all participants receive feedback (work faster, mistake, too slow) and are reprimanded concerning their performance. Two investigators in white coats observe the participants with critical facial expression, which is projected to participants through live-video feed during the tasks. The relaxation condition includes easy versions of arithmetic and figure matching task without time constrains or any type feedback on their performance. Performance and relaxation phases are appear in alternating order.
real-time fMRI neurofeedbackBehavioural
Two real-time fMRI neurofeedback sessions of 9:30 minutes each are conducted. During these sessions, the participants are instructed to regulate a feedback signal from the ACC. Participants are assigned to either the experimental or Yoke-control group through an automated double-blind procedure. In the neurofeedback sessions, participants in the experimental group receive a feedback signal indicating their current ACC activation. Participants in the control group receive the recorded feedback signal from another participant. The neurofeedback sessions follow a block structure with alternating feedback and rest periods.
Before, between, and after the two sections of the fMRI examination, subjective stress levels and alcohol craving are assessed, and saliva samples are collected for cortisol level determination.
| Study group | Role | What they receive |
|---|---|---|
| real-time fMRI neurofeedback (of the ACC) | Experimental | Participants are instructed to reduce their stress-response by attempts to upregulate the ACC activity contigent on real-time feedback. Receives: Behavioral: ScanSTRESS fMRI-paradigm (Streit et al., 2014); Behavioral: real-time fMRI neurofeedback |
| Yoke-control group | Sham comparator | Participants receive previously recorded feedback signal from other participants\' ACC activity instead of their own live ACC activity. Receives: Behavioral: ScanSTRESS fMRI-paradigm (Streit et al., 2014); Behavioral: real-time fMRI neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurofeedback/Stress-Regulation Parameters
During neurofeedback runs, participants' activation changes in the region of interest (ROI) is sampled and compared to a previously determined baseline activation (localizer task). The ROI participants are tasked to regulate is the ACC. Successful regulation is characterized as significant increase (upregulation) of the ACC as compared to baseline activation.
Measured: Assessed during each of the two neurofeedback runs, 9:30 minutes respectively
Stress-induced neural activation
Regional activation and network activation characterized during ScanSTRESS paradigm through means of contrast testing ("performance" condition vs "rest" condition)
Measured: 23 minutes - 2 runs lasting 11:20 minutes each
Cortisol
Cortisol will be assessed through saliva samples
Measured: Three measurement time points: 1. T0: 10 minutes before the ScanStress Test 2. T1: 33 minutes after T0 (after the ScanStress Test) 3. T2: 52 minutes after T0 (after both fMRI paradigms -ScanStress & Neurofeedback)
Craving
Self-report assessment questionnaire, Craving Automated Scale for Alcohol (CAS-A, Vollstädt-Klein et. al., 2015),
Measured: Three measurement time points: 1. T0: 10 minutes before the ScanStress Test 2. T1: 33 minutes after T0 (after the ScanStress Test) 3. T2: 52 minutes after T0 (after both fMRI paradigms -ScanStress & Neurofeedback)
Ecological/electronic Momentary Assessment (movisensXS)
Participants install the study app (movisensXS) on their mobile phones. During the six-week follow-up phase, data on daily stress experiences and alcohol consumption are collected through the study app. The study app assesses stress experiences, alcohol cravings, alcohol consumption, social interactions, health behavior, and coping with stress situations through short queries. The queries occur once daily at a random time between 10am and 8pm and last approximately 60 seconds. Participants can postpone the queries by up to 15 minutes or decline them altogether. Additionally, three extra queries regarding alcohol consumption are conducted once a week. During these queries, participants are asked to report their stress experiences, alcohol consumption, alcohol cravings, alcohol-related triggers, social interactions, coping with stress situations, health behavior (e.g., sleep duration), and goals related to alcohol consumption (duration of individual queries approx. 120 seconds.
Measured: 6 weeks starting from the conclusion of the neurofeedback intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start1 Mar 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Alcohol AbuseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Firstly,.all participants are assigned to either the experimental or the sham-control (Yoke-control) group through a fully automated, double-blind procedure. All participants undergo one neurofeedback (NFB) session with two runs à 9:30 mins. The NFB runs have a block structure with alternating periods/ blocks of self-regulation and rest. Participants of both groups receive the instruction to decrease their stress-response (thus, upregulating their ACC activity), through whichever strategy helps them to achieve this goal. The experimental group receives real-time fMRI feedback of their respective ACC activity. The sham-control group or Yoke-control group receives a previously acquired recording of the neurofeedback signal from a different participant instead of their own real-time ACC activity.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Institute of Mental Health, Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin F Gerchen, PhD, Principal investigator, Central Institute of Mental HealthPeter Kirsch, Prof., PhD, Principal investigator, Central Institute of Mental HealthFalk Kiefer, MD, PhD, Principal investigator, Central Institute of Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247306
- Sponsor's protocol ID
- U1111-1302-2402
- Other IDs
- TRR265-C04
- Acronym
- NeuStress
- Status last verified
- Jan 2025
- First submitted
- 13 Jan 2024
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There will be collaborative data processing, sharing of data and storage of data at different locations as specified below. Research data will be stored on secure servers of the Center for Information Services and High-Performance Computing at the Dresden University of Technology (ZIH; Zellescher Weg 12, 01069 Dresden) and the ZI Mannheim. The data will be retained for 10 years after the completion or termination of the research project. Participants' data will be protected against unauthorized access, and anonymization will occur once the research purpose allows it. Data will be deleted at the latest after 10 years. Coding method: Double coding, access by project staff, emergency decoding possible during the project duration (MRT scans). Transfer of pseudonymized biomaterials/data to third parties: Name: Dresden University of Technology Address: Zellescher Weg 19, 01069 Dresden. There will be a transfer of pseudonymized saliva samples for cortisol level determination.
Publications
Wolkowicz NR, Peltier MR, Wemm S, MacLean RR. Subjective stress and alcohol use among young adult and adult drinkers: Systematic review of studies using Intensive Longitudinal Designs. Drug Alcohol Depend Rep. 2022 Mar 11;3:100039. doi: 10.1016/j.dadr.2022.100039. eCollection 2022 Jun.
PubMed 36845979Vollstadt-Klein S, Hermann D, Rabinstein J, Wichert S, Klein O, Ende G, Mann K. Increased activation of the ACC during a spatial working memory task in alcohol-dependence versus heavy social drinking. Alcohol Clin Exp Res. 2010 May;34(5):771-6. doi: 10.1111/j.1530-0277.2010.01149.x. Epub 2010 Mar 1.
PubMed 20201927Vollstadt-Klein S, Lemenager T, Jorde A, Kiefer F, Nakovics H. Development and validation of the craving automated scale for alcohol. Alcohol Clin Exp Res. 2015 Feb;39(2):333-42. doi: 10.1111/acer.12636.
PubMed 25684052Streit F, Haddad L, Paul T, Frank J, Schafer A, Nikitopoulos J, Akdeniz C, Lederbogen F, Treutlein J, Witt S, Meyer-Lindenberg A, Rietschel M, Kirsch P, Wust S. A functional variant in the neuropeptide S receptor 1 gene moderates the influence of urban upbringing on stress processing in the amygdala. Stress. 2014 Jul;17(4):352-61. doi: 10.3109/10253890.2014.921903. Epub 2014 Jun 16.
PubMed 24800784Sinha R, Li CS. Imaging stress- and cue-induced drug and alcohol craving: association with relapse and clinical implications. Drug Alcohol Rev. 2007 Jan;26(1):25-31. doi: 10.1080/09595230601036960.
PubMed 17364833Sinha R, Fox HC, Hong KA, Bergquist K, Bhagwagar Z, Siedlarz KM. Enhanced negative emotion and alcohol craving, and altered physiological responses following stress and cue exposure in alcohol dependent individuals. Neuropsychopharmacology. 2009 Apr;34(5):1198-208. doi: 10.1038/npp.2008.78. Epub 2008 Jun 18.
PubMed 18563062Seo D, Lacadie CM, Tuit K, Hong KI, Constable RT, Sinha R. Disrupted ventromedial prefrontal function, alcohol craving, and subsequent relapse risk. JAMA Psychiatry. 2013 Jul;70(7):727-39. doi: 10.1001/jamapsychiatry.2013.762.
PubMed 23636842Seo D, Lacadie CM, Sinha R. Neural Correlates and Connectivity Underlying Stress-Related Impulse Control Difficulties in Alcoholism. Alcohol Clin Exp Res. 2016 Sep;40(9):1884-94. doi: 10.1111/acer.13166. Epub 2016 Aug 8.
PubMed 27501356Koob GF, Le Moal M. Drug abuse: hedonic homeostatic dysregulation. Science. 1997 Oct 3;278(5335):52-8. doi: 10.1126/science.278.5335.52.
PubMed 9311926Kirschbaum C, Pirke KM, Hellhammer DH. The 'Trier Social Stress Test'--a tool for investigating psychobiological stress responses in a laboratory setting. Neuropsychobiology. 1993;28(1-2):76-81. doi: 10.1159/000119004.
PubMed 8255414Cox WM, Klinger E. A motivational model of alcohol use. J Abnorm Psychol. 1988 May;97(2):168-80. doi: 10.1037//0021-843x.97.2.168. No abstract available.
PubMed 3290306Clay JM, Parker MO. The role of stress-reactivity, stress-recovery and risky decision-making in psychosocial stress-induced alcohol consumption in social drinkers. Psychopharmacology (Berl). 2018 Nov;235(11):3243-3257. doi: 10.1007/s00213-018-5027-0. Epub 2018 Sep 12.
PubMed 30209533Clay JM, Adams C, Archer P, English M, Hyde A, Stafford LD, Parker MO. Psychosocial stress increases craving for alcohol in social drinkers: Effects of risk-taking. Drug Alcohol Depend. 2018 Apr 1;185:192-197. doi: 10.1016/j.drugalcdep.2017.12.021. Epub 2018 Feb 15.
PubMed 29462766Bush K, Kivlahan DR, McDonell MB, Fihn SD, Bradley KA. The AUDIT alcohol consumption questions (AUDIT-C): an effective brief screening test for problem drinking. Ambulatory Care Quality Improvement Project (ACQUIP). Alcohol Use Disorders Identification Test. Arch Intern Med. 1998 Sep 14;158(16):1789-95. doi: 10.1001/archinte.158.16.1789.
PubMed 9738608Blaine SK, Seo D, Sinha R. Peripheral and prefrontal stress system markers and risk of relapse in alcoholism. Addict Biol. 2017 Mar;22(2):468-478. doi: 10.1111/adb.12320. Epub 2015 Nov 5.
PubMed 26537217
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probing the Influence of Neural Stress Responses on Problematic Alcohol Use With Real-time fMRI Neurofeedback (C04)
- ClinicalTrials.gov ID
- NCT06247306
- Acronym / sponsor ID
- NeuStress / U1111-1302-2402
- Conditions
- Alcohol Abuse, Craving, Psychosocial Stressor, Neural Stress Response
- Keywords
- functional Magnetic Resonance Imaging (fMRI), psychosocial stress, real-time fMRI neurofeedback (rtfMRI neurofeedback), problematic alcohol use, cortisol, Ecological momentary assessment (EMA)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Central Institute of Mental Health, MannheimUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 7 Feb 2024 (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.
In this research project, the aim is to discover the role specific brain networks play in the relationship between stress reactions and the desire for alcohol and alcohol consumption. To investigate this question, various brain imaging methods as well as cognitive tasks are combined. Various questionnaires are sampled and brain scans are conducted.
Individuals interested in participating in the study have to fulfill certain criteria...
- no serious medical or mental health diagnosis
- problematic alcohol drinking habits
- interested in improving drinking habits ...and undergo various non-invasive procedures
- filling out several questionnaires concerning personality and habits
- undergoing a mental performance task while being in a brain scanner (MRI)
- attempting to regulate their own brain activity while lying in the MRI scanner
- filling out an electronic diary for 6 weeks - concerning daily mood, stress, and alcohol habits
Participants will be randomly allocated to either one of 2 experimental groups. Both groups undergo the same tasks, receive the same instructions and only differ regarding some aspects of the brain self-regulation task .
Detailed description
While it is well known and long acknowledged in scientific research that stress and alcohol consumption are closely linked, the actual relationship is complex, and the underlying mechanisms are only partially understood. To investigate the effects of acute stress under controlled conditions, experimental procedures, stress tests, and related paradigms are often employed. Studies on alcohol addiction generally indicate an increase in acute cravings following the experimental induction of stress. Neurologically, acute stress induction is associated with activation changes in widespread networks. In particular, research employing stress tests found increased activations in striatum, thalamus and limbic areas and deactivations in anterior cingulate cortex (ACC) as well as ventromedial prefrontal cortex (vmPFC), areas often associated with emotion regulation during stress induction. Given their role in emotion regulation, deactivations in these areas could reflect a reduction in emotional control during acute stress. Deactivation of these areas during experimentally induced stress has also been linked to problematic alcohol consumption and increased alcohol cravings.
This study aims to elucidate how neurocognitive processes during stress influence alcohol cravings and consumption. To this end, participants with problematic alcohol consumption will be recruited. After having filled out various questionnaires pertaining to their biographical data, alcohol consumption and personality traits, participants will be experimentally stressed during a brain scan using functional Magnetic Resonance Imaging (fMRI). To reliably induce psychosocial stress, the ScanSTRESS test, a paradigm explicitly conceptualized for usage during MRI scanning, will be employed. Once the stress test is completed, participants will attempt to regulate their own neurological stress response through upregulation of the ACC using information about their current stress-induced brain activity (neurofeedback). Additionally, saliva samples will be regularly taken during the experiment to biologically observe the stress response through cortisol measurements. This will be followed by a 6-week follow-up phase, during which participants will be specifically asked about their alcohol cravings, alcohol consumption, and daily stress experiences.
By employing real-time fMRI neurofeedback, this study creates experimental conditions in which participants can self-regulate the neural stress response of the targeted brain network. Nonspecific effects of the neurofeedback paradigm are controlled using a sham condition (Yoke-control group). Participants are randomly assigned to either the control group or the real neurofeedback group (experimental group). This approach allows for the investigation of the neural self-regulation abilities of emotional control networks and their role in the connection between stress, alcohol cravings, and drinking behavior in real life.
In summary, this study aims to examine the relationship between the self-regulation abilities of neural stress responses and real-life drinking behavior.
Investigators hypothesize that 1) the stress experiment significantly increases acute self-reported stress in participants, 2) specifically stress-induced patterns of neural activity, namely increased striatal and thalamic activity as well as decreased ACC activity, predict alcohol cravings and consumption, 3) the experimental neurofeedback group exhibits higher ACC activity during brain self-regulation than the control group, 4) the experimental group shows lower alcohol craving/consumption during the follow-up phase.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Firstly,.all participants are assigned to either the experimental or the sham-control (Yoke-control) group through a fully automated, double-blind procedure. All participants undergo one neurofeedback (NFB) session with two runs à 9:30 mins. The NFB runs have a block structure with alternating periods/ blocks of self-regulation and rest. Participants of both groups receive the instruction to decrease their stress-response (thus, upregulating their ACC activity), through whichever strategy helps them to achieve this goal. The experimental group receives real-time fMRI feedback of their respective ACC activity. The sham-control group or Yoke-control group receives a previously acquired recording of the neurofeedback signal from a different participant instead of their own real-time ACC activity.
| Arm | Type | Receives |
|---|---|---|
| real-time fMRI neurofeedback (of the ACC) | Experimental | Behavioral: ScanSTRESS fMRI-paradigm (Streit et al., 2014), Behavioral: real-time fMRI neurofeedbackParticipants are instructed to reduce their stress-response by attempts to upregulate the ACC activity contigent on real-time feedback. |
| Yoke-control group | Sham comparator | Behavioral: ScanSTRESS fMRI-paradigm (Streit et al., 2014), Behavioral: real-time fMRI neurofeedbackParticipants receive previously recorded feedback signal from other participants\' ACC activity instead of their own live ACC activity. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-65 years
- Presence of 2 to a maximum of 5 criteria for alcohol use disorder according to DSM-5
- no clinical necessity for detoxification treatment
- participants may have a moderate cannabis use disorder and tobacco use disorder
- Capacity for consent and ability to use self-assessment scales
Key exclusion criteria (7 listed)
- Lifetime diagnosis of bipolar or psychotic disorder or a substance use disorder according to Diagnostical and Statistical Manual of Mental Disorders - 5 (DSM-5) that is not alcohol, cannabis, or tobacco use disorder
- Current substance use other than cannabis and tobacco
- Current diagnosis of one of the following conditions according to DSM-5: (hypo)manic episode, major depression, generalized anxiety disorder, post-traumatic stress disorder, borderline personality disorder, or obsessive-compulsive disorder
- History of severe head trauma or other severe central neurological disorders (dementia, Parkinson\'s disease, multiple sclerosis)
- Pregnancy or lactation
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 |
|---|---|---|
| ScanSTRESS fMRI-paradigm (Streit et al., 2014)The task is conducted within the MRI scanner and consists of two runs each lasting 11:20 mins., employs a block design and has two different conditions (performance, relaxation), as well as two different task within each condition. Participants undergo the following 2 tasks during the performance condition under time pressure: 1) serial subtraction, 2) a figure matching task. During the performance condition, all participants receive feedback (work faster, mistake, too slow) and are reprimanded concerning their performance. Two investigators in white coats observe the participants with critical facial expression, which is projected to participants through live-video feed during the tasks. The relaxation condition includes easy versions of arithmetic and figure matching task without time constrains or any type feedback on their performance. Performance and relaxation phases are appear in alternating order. | Behavioural | Yoke-control group, real-time fMRI neurofeedback (of the ACC) |
| real-time fMRI neurofeedbackTwo real-time fMRI neurofeedback sessions of 9:30 minutes each are conducted. During these sessions, the participants are instructed to regulate a feedback signal from the ACC. Participants are assigned to either the experimental or Yoke-control group through an automated double-blind procedure. In the neurofeedback sessions, participants in the experimental group receive a feedback signal indicating their current ACC activation. Participants in the control group receive the recorded feedback signal from another participant. The neurofeedback sessions follow a block structure with alternating feedback and rest periods. Before, between, and after the two sections of the fMRI examination, subjective stress levels and alcohol craving are assessed, and saliva samples are collected for cortisol level determination. | Behavioural | Yoke-control group, real-time fMRI neurofeedback (of the ACC) |
Primary outcome
Neurofeedback/Stress-Regulation Parameters
Time frame: Assessed during each of the two neurofeedback runs, 9:30 minutes respectively
During neurofeedback runs, participants' activation changes in the region of interest (ROI) is sampled and compared to a previously determined baseline activation (localizer task). The ROI participants are tasked to regulate is the ACC. Successful regulation is characterized as significant increase (upregulation) of the ACC as compared to baseline activation.
Stress-induced neural activation
Time frame: 23 minutes - 2 runs lasting 11:20 minutes each
Regional activation and network activation characterized during ScanSTRESS paradigm through means of contrast testing ("performance" condition vs "rest" condition)
Cortisol
Time frame: Three measurement time points: 1. T0: 10 minutes before the ScanStress Test 2. T1: 33 minutes after T0 (after the ScanStress Test) 3. T2: 52 minutes after T0 (after both fMRI paradigms -ScanStress & Neurofeedback)
Cortisol will be assessed through saliva samples
Craving
Time frame: Three measurement time points: 1. T0: 10 minutes before the ScanStress Test 2. T1: 33 minutes after T0 (after the ScanStress Test) 3. T2: 52 minutes after T0 (after both fMRI paradigms -ScanStress & Neurofeedback)
Self-report assessment questionnaire, Craving Automated Scale for Alcohol (CAS-A, Vollstädt-Klein et. al., 2015),
Ecological/electronic Momentary Assessment (movisensXS)
Time frame: 6 weeks starting from the conclusion of the neurofeedback intervention
Participants install the study app (movisensXS) on their mobile phones. During the six-week follow-up phase, data on daily stress experiences and alcohol consumption are collected through the study app. The study app assesses stress experiences, alcohol cravings, alcohol consumption, social interactions, health behavior, and coping with stress situations through short queries. The queries occur once daily at a random time between 10am and 8pm and last approximately 60 seconds. Participants can postpone the queries by up to 15 minutes or decline them altogether. Additionally, three extra queries regarding alcohol consumption are conducted once a week. During these queries, participants are asked to report their stress experiences, alcohol consumption, alcohol cravings, alcohol-related triggers, social interactions, coping with stress situations, health behavior (e.g., sleep duration), and goals related to alcohol consumption (duration of individual queries approx. 120 seconds.
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 23 Jan 2025.
- Background: PubMed 36845979Wolkowicz NR, Peltier MR, Wemm S, MacLean RR. Subjective stress and alcohol use among young adult and adult drinkers: Systematic review of studies using Intensive Longitudinal Designs. Drug Alcohol Depend Rep. 2022 Mar 11;3:100039. doi: 10.1016/j.dadr.2022.100039. eCollection 2022 Jun.
- Background: PubMed 20201927Vollstadt-Klein S, Hermann D, Rabinstein J, Wichert S, Klein O, Ende G, Mann K. Increased activation of the ACC during a spatial working memory task in alcohol-dependence versus heavy social drinking. Alcohol Clin Exp Res. 2010 May;34(5):771-6. doi: 10.1111/j.1530-0277.2010.01149.x. Epub 2010 Mar 1.
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- Individual participant dataSharing planned: Yes. There will be collaborative data processing, sharing of data and storage of data at different locations as specified below. Research data will be stored on secure servers of the Center for Information Services and High-Performance Computing at the Dresden University of Technology (ZIH; Zellescher Weg 12, 01069 Dresden) and the ZI Mannheim. The data will be retained for 10 years after the completion or termination of the research project. Participants' data will be protected against unauthorized access, and anonymization will occur once the research purpose allows it. Data will be deleted at the latest after 10 years. Coding method: Double coding, access by project staff, emergency decoding possible during the project duration (MRT scans). Transfer of pseudonymized biomaterials/data to third parties: Name: Dresden University of Technology Address: Zellescher Weg 19, 01069 Dresden. There will be a transfer of pseudonymized saliva samples for cortisol level determination.
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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.
Martin F Gerchen, PhD principal investigator
Central Institute of Mental Health
Peter Kirsch, Prof., PhD principal investigator
Central Institute of Mental Health
Falk Kiefer, MD, PhD principal investigator
Central Institute of Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ScanSTRESS fMRI-paradigm (Streit et al., 2014) and real-time fMRI neurofeedback in people with Alcohol Abuse and Craving, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
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 7 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: looking for participants now, as of the sponsor's last update on 23 Jan 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 Germany. 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. Some participants in this study may receive a placebo. 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 Nina J Kempf, M. Sc. (+ 49/621-1703 ext. 6529, nina.kempf@zi-mannheim.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurofeedback/Stress-Regulation Parameters (time frame: Assessed during each of the two neurofeedback runs, 9:30 minutes respectively). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06247306, which also lists 16 linked publications.
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 23 Jan 2025.