Skip to main content
Clinical Trials/NCT02486900
NCT02486900
Completed
Not Applicable

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

Cardiff University1 site in 1 country52 target enrollmentSeptember 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alcohol Dependence
Sponsor
Cardiff University
Enrollment
52
Locations
1
Primary Endpoint
Indices of drinking (continuous) - % days abstinent
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

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).

Registry
clinicaltrials.gov
Start Date
September 2015
End Date
August 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David Linden

Professor of Translational Neuroscience

Cardiff University

Eligibility Criteria

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
  • 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

Outcomes

Primary Outcomes

Indices of drinking (continuous) - % days abstinent

Time Frame: 4 months after baseline assessment/first training

Derived from the Timeline Followback Calendar.

Indices of drinking (continuous) - drinks per drinking day

Time Frame: 4 months after baseline assessment/first training

Derived from the Timeline Followback Calendar.

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

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

Study Sites (1)

Loading locations...

Similar Trials