Clinical trial NCT02486900: Neurofeedback & Alcohol Dependence
Official title: Real-time fMRI Neurofeedback as a Treatment Tool for Alcohol Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Dependence
Keywords: Craving
Cue Reactivity
Neurofeedback
Lead sponsor: Cardiff University
Sponsor class: OTHER
Collaborators: name: European Commission
First posted: 2015-07-01
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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
* 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

Primary outcomes:
measure: Indices of drinking (continuous) - % days abstinent
timeFrame: 4 months after baseline assessment/first training
measure: Indices of drinking (continuous) - drinks per drinking day
timeFrame: 4 months after baseline assessment/first training
measure: Indices of drinking (continuous) - % days of 'heavy drinking'
timeFrame: 4 months after baseline assessment/first training
Secondary outcomes:
measure: Drinking urges/craving assessed with the Drinking Urges Questionnaire (DUQ)
timeFrame: Assessed 4 months, 8 months and 12 months after baseline
measure: Drinking urges/craving assessed with the Obsessive Compulsive Drinking Scale (OCDS)
timeFrame: Assessed 4 months, 8 months and 12 months after baseline
measure: Drinking urges/craving (attentional bias) assessed with the alcohol stroop test
timeFrame: Assessed 4 months, 8 months and 12 months after baseline
measure: Craving self-ratings during scanning (neurofeedback group only)
timeFrame: Assessed 2, 4, 6, 8, 12, 16 weeks after baseline (each training session)
measure: Profile of Mood States Questionnaire
timeFrame: Assessed 4 months, 8 months and 12 months after baseline
measure: Beck Depression Inventory
timeFrame: Assessed 4 months, 8 months and 12 months after baseline
measure: Hospital Anxiety and Depression Scale
timeFrame: Assessed 4 months, 8 months and 12 months after baseline
measure: NHS Resource Use Questionnaire
timeFrame: Assessed 4 months, 8 months and 12 months after baseline
measure: Debriefing Questionnaire (neurofeedback group only)
timeFrame: Assessed 2, 4, 6, 8, 12, 16 weeks after baseline (each training session)
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: School of Medicine, Cardiff University
state: Wales
Study officials:
affiliation: Cardiff University
name: David Linden, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cox WM, Subramanian L, Linden DE, Luhrs M, McNamara R, Playle R, Hood K, Watson G, Whittaker JR, Sakhuja R, Ihssen N. Neurofeedback training for alcohol dependence versus treatment as usual: study protocol for a randomized controlled trial. Trials. 2016 Oct 3;17(1):480. doi: 10.1186/s13063-016-1607-7.