Neurofeedback & Alcohol Dependence

Alcohol Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02486900
• Other study ID #: BRAINTRAINAD
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: August 2018

Study information

• Verified date: January 2019
• Source: Cardiff University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	School of Medicine, Cardiff University	Cardiff	Wales

Sponsors (2)

Lead Sponsor	Collaborator
Cardiff University	European Commission

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Indices of drinking (continuous) - % days abstinent	Derived from the Timeline Followback Calendar.	4 months after baseline assessment/first training
Primary	Indices of drinking (continuous) - drinks per drinking day	Derived from the Timeline Followback Calendar.	4 months after baseline assessment/first training
Primary	Indices of drinking (continuous) - % days of 'heavy drinking'	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	Drinking urges/craving assessed with the Drinking Urges Questionnaire (DUQ)		Assessed 4 months, 8 months and 12 months after baseline
Secondary	Drinking urges/craving assessed with the Obsessive Compulsive Drinking Scale (OCDS)		Assessed 4 months, 8 months and 12 months after baseline
Secondary	Drinking urges/craving (attentional bias) assessed with the alcohol stroop test		Assessed 4 months, 8 months and 12 months after baseline
Secondary	Craving self-ratings during scanning (neurofeedback group only)		Assessed 2, 4, 6, 8, 12, 16 weeks after baseline (each training session)
Secondary	Profile of Mood States Questionnaire		Assessed 4 months, 8 months and 12 months after baseline
Secondary	Beck Depression Inventory		Assessed 4 months, 8 months and 12 months after baseline
Secondary	Hospital Anxiety and Depression Scale		Assessed 4 months, 8 months and 12 months after baseline
Secondary	NHS Resource Use Questionnaire		Assessed 4 months, 8 months and 12 months after baseline
Secondary	Debriefing Questionnaire (neurofeedback group only)		Assessed 2, 4, 6, 8, 12, 16 weeks after baseline (each training session)