Neurofeedback & Alcohol Dependence

January 31, 2019 updated by: David Linden, Cardiff University

Real-time fMRI Neurofeedback as a Treatment Tool for 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Wales
      • Cardiff, Wales, United Kingdom, CF14 4XN
        • School of Medicine, Cardiff University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neurofeedback training group
The neurofeedback group will perform 6 training sessions over a period of 4 months: 4 fortnightly sessions in the first two months will be followed by 2 monthly 'booster' sessions. Each session will include several behavioural assessments and fMRI-based neurofeedback training in an MRI scanner (1 h). The neurofeedback training phase will be be followed-up by two behavioural assessments 8 and 12 months after the first training.
Device: fMRI-based neurofeedback
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.
No Intervention: Treatment-as-usual control group
The control group will receive treatment as usual (e.g. medication, counselling) but no neurofeedback training during the study period. Patients in the control group will be invited for four behavioural assessment sessions (baseline assessment, follow-up assessments 4/8/12 months after baseline).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Indices of drinking (continuous) - % days abstinent
Time Frame: 4 months after baseline assessment/first training
Derived from the Timeline Followback Calendar.
4 months after baseline assessment/first training
Indices of drinking (continuous) - drinks per drinking day
Time Frame: 4 months after baseline assessment/first training
Derived from the Timeline Followback Calendar.
4 months after baseline assessment/first training
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.
4 months after baseline assessment/first training

Secondary Outcome Measures

Outcome Measure
Time Frame
Drinking urges/craving assessed with the Drinking Urges Questionnaire (DUQ)
Time Frame: Assessed 4 months, 8 months and 12 months after baseline
Assessed 4 months, 8 months and 12 months after baseline
Drinking urges/craving assessed with the Obsessive Compulsive Drinking Scale (OCDS)
Time Frame: Assessed 4 months, 8 months and 12 months after baseline
Assessed 4 months, 8 months and 12 months after baseline
Drinking urges/craving (attentional bias) assessed with the alcohol stroop test
Time Frame: Assessed 4 months, 8 months and 12 months after baseline
Assessed 4 months, 8 months and 12 months after baseline
Craving self-ratings during scanning (neurofeedback group only)
Time Frame: Assessed 2, 4, 6, 8, 12, 16 weeks after baseline (each training session)
Assessed 2, 4, 6, 8, 12, 16 weeks after baseline (each training session)
Profile of Mood States Questionnaire
Time Frame: Assessed 4 months, 8 months and 12 months after baseline
Assessed 4 months, 8 months and 12 months after baseline
Beck Depression Inventory
Time Frame: Assessed 4 months, 8 months and 12 months after baseline
Assessed 4 months, 8 months and 12 months after baseline
Hospital Anxiety and Depression Scale
Time Frame: Assessed 4 months, 8 months and 12 months after baseline
Assessed 4 months, 8 months and 12 months after baseline
NHS Resource Use Questionnaire
Time Frame: Assessed 4 months, 8 months and 12 months after baseline
Assessed 4 months, 8 months and 12 months after baseline
Debriefing Questionnaire (neurofeedback group only)
Time Frame: Assessed 2, 4, 6, 8, 12, 16 weeks after baseline (each training session)
Assessed 2, 4, 6, 8, 12, 16 weeks after baseline (each training session)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiff University

Collaborators

European Commission

Investigators

  • Principal Investigator: David Linden, MD, Cardiff University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

June 26, 2015

First Submitted That Met QC Criteria

June 30, 2015

First Posted (Estimate)

July 1, 2015

Study Record Updates

Last Update Posted (Actual)

February 1, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRAINTRAINAD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alcohol Dependence

Clinical Trials on fMRI-based neurofeedback

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Senegal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe