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Completed

NCT Number: NCT02486900

Neurofeedback & Alcohol Dependence

The study aims to examine whether the neurofeedback method (based on functional magnetic resonance imaging [fMRI]) can help patients with alcohol dependence to control their urges to drink alcohol and thus to remain abstinent. Potential effects of neurofeedback on abstinence and drinking behaviour will be evaluated based on the comparison between a group of patients receiving multiple sessions of neurofeedback training and a group of patients receiving treatment as usual over the same period of time.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Medicine, Cardiff University

Cardiff, Wales, CF14 4XN, United Kingdom

About this study

Neurofeedback is a non-invasive neuroscientific tool in which participants receive real-time feedback about their brain activity while undergoing functional magnetic resonance imaging. Previous research has shown that participants can successfully use the feedback to self-regulate their brain responses. In this study patients who have successfully completed a detoxification programme will be trained to down-regulate/upregulate responses of motivational brain regions that are activated during exposure to alcohol/life goal-related stimuli (pictures of alcoholic drinks/life goals related). The investigators hypothesise that learning to self-regulate these neural responses will enable patients to better control craving responses to environmental alcohol cues after detoxification treatment. Patients in the intervention group will undergo 6 neurofeedback training sessions, spread across 4 months. Outcomes of the training will be compared with a group of patients who will not do the neurofeedback training but receive standard treatment (e.g. support groups and medication).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Successful completion of detoxification programme within a time window of 1 to 6 months before the recruitment
  • Abstinence since detoxification treatment

Exclusion criteria

  • Ongoing regular abuse of illicit substances except cannabis
  • History of psychotic disorders not related to alcohol
  • IQ < 70
  • Involvement in other interventional research in the past 6 months
  • MRI counter-indications, e.g. claustrophobia, pregnancy, active medical implants, passive implants deemed unsuitable, metallic dust in the eyes, certain types of metal prostheses, surgical clips, previous experience with metalworking without eye protection

Treatment and study plan

fMRI-based neurofeedback

Device

During scanning patients will be exposed to picture stimuli (showing alcoholic drinks and life goals) projected on a screen behind the scanner and viewed through a mirror attached on the MRI head coil. In each session patients will be trained to down-regulate/up-regulate activation levels in brain areas that show reliable responses to the alcohol/life goals pictures in a 'localiser' scan. Self-regulation of these brain responses will then be guided by real-time feedback of alcohol/life goals-cue elicited activation, consisting of changes in the visible alcohol/life goals picture (decreasing size = successful down-regulation; increasing size = successful upregulation). Functional MRI data will be acquired in short blocks having a duration of 5-8 minutes.

Primary outcomes

  1. Indices of drinking (continuous) - % days abstinent

    Time frame: 4 months after baseline assessment/first training

    Derived from the Timeline Followback Calendar.

  2. Indices of drinking (continuous) - drinks per drinking day

    Time frame: 4 months after baseline assessment/first training

    Derived from the Timeline Followback Calendar.

  3. Indices of drinking (continuous) - % days of 'heavy drinking'

    Time frame: 4 months after baseline assessment/first training

    Defined as 8 or more alcohol units per day/men or 6 or more units/women. Derived from the Timeline Followback Calendar.

Secondary outcomes

  1. Drinking urges/craving assessed with the Drinking Urges Questionnaire (DUQ)

    Time frame: Assessed 4 months, 8 months and 12 months after baseline

  2. Drinking urges/craving assessed with the Obsessive Compulsive Drinking Scale (OCDS)

    Time frame: Assessed 4 months, 8 months and 12 months after baseline

  3. Drinking urges/craving (attentional bias) assessed with the alcohol stroop test

    Time frame: Assessed 4 months, 8 months and 12 months after baseline

  4. Craving self-ratings during scanning (neurofeedback group only)

    Time frame: Assessed 2, 4, 6, 8, 12, 16 weeks after baseline (each training session)

  5. Profile of Mood States Questionnaire

    Time frame: Assessed 4 months, 8 months and 12 months after baseline

  6. Beck Depression Inventory

    Time frame: Assessed 4 months, 8 months and 12 months after baseline

  7. Hospital Anxiety and Depression Scale

    Time frame: Assessed 4 months, 8 months and 12 months after baseline

  8. NHS Resource Use Questionnaire

    Time frame: Assessed 4 months, 8 months and 12 months after baseline

  9. Debriefing Questionnaire (neurofeedback group only)

    Time frame: Assessed 2, 4, 6, 8, 12, 16 weeks after baseline (each training session)

Sponsors and collaborators

Lead sponsor

Cardiff University

Other

Collaborators

  • European Commission

Registry information

Official study title

Real-time fMRI Neurofeedback as a Treatment Tool for Alcohol Dependence

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jul 1, 2015
Registry last updated
Feb 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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