Neurofeedback & Alcohol Dependence

NCT02486900 | Completed

• 1 other identifier: BRAINTRAINAD
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Dependence

Keywords

Craving; Cue Reactivity; Neurofeedback

Outcome Measures

Primary Outcomes (3)

• Indices of drinking (continuous) - % days abstinent

  Derived from the Timeline Followback Calendar.

  4 months after baseline assessment/first training

• Indices of drinking (continuous) - drinks per drinking day

  Derived from the Timeline Followback Calendar.

  4 months after baseline assessment/first training

• 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 Outcomes (9)

• 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 Arms (2)

Neurofeedback training group

EXPERIMENTAL

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

Treatment-as-usual control group

NO INTERVENTION

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).

Interventions

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.

Neurofeedback training group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardiff University: lead
• European Commission: collaborator

Study Sites (1)

School of Medicine, Cardiff University

Cardiff, Wales, CF14 4XN, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 27716290 DERIVED

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• David Linden, MD

  Cardiff University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Translational Neuroscience

Study Record Dates

• First Submitted: June 26, 2015
• First Posted: July 1, 2015
• Study Start: September 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: August 1, 2018
• Last Updated: February 1, 2019

Record last verified: 2019-01

Locations

GB (1)