Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06247306

Probing the Influence of Neural Stress Responses on Problematic Alcohol Use With Real-time fMRI Neurofeedback (C04)

Led by Central Institute of Mental Health, Mannheim · Updated on 2025-01-23

102

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research focuses on understanding how specific brain networks influence the link between stress reactions and problematic alcohol use. Researchers aim to clarify the complex relationship between stress, alcohol cravings, and consumption by studying participants with problematic drinking habits. The study uses advanced brain imaging, cognitive tasks, and questionnaires to explore how stress impacts neural activity and drinking behavior. Participants are randomly assigned to one of two groups: one receives real-time brain activity feedback from the anterior cingulate cortex (ACC) to help regulate stress responses, while the other receives prerecorded feedback from another participant as a control. Both groups undergo a stress test called ScanSTRESS during functional MRI scanning, followed by neurofeedback sessions where they try to modulate their brain activity. Saliva samples are collected to measure cortisol levels, and participants complete electronic diaries about mood, stress, and alcohol use over six weeks. During the study, participants complete questionnaires, perform mental tasks inside the MRI scanner, and attempt brain self-regulation with feedback. Researchers measure stress-related brain activation, cortisol levels, and self-reported alcohol craving at multiple points during the sessions. The six-week follow-up uses daily electronic assessments to track alcohol use, cravings, and stress, helping to understand how brain self-regulation relates to real-life drinking behaviors. Overall, the study combines brain imaging, biological tests, and behavioral data to investigate neural stress responses and alcohol use.

CONDITIONS

Brief Title

Using Neurofeedback to Understand the Relationship Between Stress and Alcohol Consumption

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-65 years
  • Have 2 to 5 criteria for alcohol use disorder according to DSM-5
  • No clinical need for detoxification treatment
  • May have moderate cannabis or tobacco use disorder
  • Able to consent and use self-assessment scales
  • Sufficient knowledge of German
  • Willing to use an Android mobile phone
Not Eligible

You will not qualify if you...

  • Lifetime diagnosis of bipolar or psychotic disorder or substance use disorder other than alcohol, cannabis, or tobacco
  • Current use of substances other than cannabis and tobacco
  • Current diagnosis of (hypo)manic episode, major depression, generalized anxiety disorder, PTSD, borderline personality disorder, or OCD
  • History of severe head trauma or severe neurological disorders
  • Pregnancy or lactation
  • Use of medications affecting the central nervous system within the last 10 days
  • Exercising the right not to know about incidental findings during examinations

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Stress Induction and Neurofeedback Treatment

Duration - Single study day lasting approximately 2 hours

Participants undergo a controlled stress test inside an MRI scanner, involving tasks under pressure with live observation to induce psychosocial stress. Following this, participants complete two sessions of real-time fMRI neurofeedback to regulate their stress response, with saliva samples collected to measure cortisol and assessments of stress and alcohol craving taken before, during, and after the sessions.

1 visit (in-person)

Follow-up Monitoring

Duration - 6 weeks

Participants report daily alcohol cravings, consumption, and stress experiences using electronic assessments over a 6-week period following the neurofeedback intervention.

Daily electronic assessments during follow-up

Trial Site Locations

Total: 1 location

1

Central Institute of Mental Health - Department of Clinical Psychology

Mannheim, Baden-Wurttemberg, Germany, 68159

Actively Recruiting

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Research Team

N

Nina J Kempf, M. Sc.

L

Lea Wazulin, M. Sc.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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Published Research Related To This Trial

Subjective stress and alcohol use among young adult and adult drinkers: Systematic review of studies using Intensive Longitudinal Designs.

Noah R Wolkowicz, MacKenzie R Peltier, Stephanie Wemm...

https://pubmed.ncbi.nlm.nih.gov/36845979

Increased activation of the ACC during a spatial working memory task in alcohol-dependence versus heavy social drinking.

Sabine Vollstädt-Klein, Derik Hermann, Juri Rabinstein...

https://pubmed.ncbi.nlm.nih.gov/20201927

A functional variant in the neuropeptide S receptor 1 gene moderates the influence of urban upbringing on stress processing in the amygdala.

Fabian Streit, Leila Haddad, Torsten Paul...

https://pubmed.ncbi.nlm.nih.gov/24800784

Enhanced negative emotion and alcohol craving, and altered physiological responses following stress and cue exposure in alcohol dependent individuals.

Rajita Sinha, Helen C Fox, Kwangik A Hong...

https://pubmed.ncbi.nlm.nih.gov/18563062