Using Neurofeedback to Understand the Relationship Between Stress and Alcohol Consumption (NCT06247306) | Clinical Trial Compass
RecruitingNot Applicable
Using Neurofeedback to Understand the Relationship Between Stress and Alcohol Consumption
Germany102 participantsStarted 2024-03-01
Plain-language 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. 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 .
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Neurofeedback/Stress-Regulation Parameters
Timeframe: Assessed during each of the two neurofeedback runs, 9:30 minutes respectively
2
Stress-induced neural activation
Timeframe: 23 minutes - 2 runs lasting 11:20 minutes each
3
Cortisol
Timeframe: 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)
4
Craving
Timeframe: 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)