Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02486900
Other study ID # BRAINTRAINAD
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
See also
  Status Clinical Trial Phase
Completed NCT02901041 - Interdisciplinary Study of A Novel Anticonvulsant in Alcoholism Phase 3
Completed NCT03340051 - Remote Alcohol Monitoring and Episodic Thinking N/A
Not yet recruiting NCT06444243 - Psilocybin-assisted Therapy for Alcohol Use Disorder Phase 2
Completed NCT02705898 - Lifestyle Physical Activity Intervention for Depressed Alcohol Dependent Women N/A
Completed NCT02197598 - Treatment of Patients Suffering of Alcohol Dependence and Impaired Liver Function With Selincro® As-needed Use Phase 4
Completed NCT02179749 - Mifepristone Treatment of Alcohol Use Disorder Phase 2
Recruiting NCT02385643 - The Efficacy of A Smartphone-based Support System to Reinforce Alcohol Abstinence in Treatment-seeking Patients N/A
Completed NCT01828866 - Eye Movement Desensitization and Reprocessing (EMDR) in Alcohol Dependent Patients N/A
Terminated NCT01408641 - Topiramate for Alcohol Use in Posttraumatic Stress Disorder N/A
Active, not recruiting NCT01182766 - New Treatment for Alcohol and Nicotine Dependence Phase 2/Phase 3
Completed NCT01342549 - Treatment Strategy for Alcohol Use Disorders in Veterans With TBI Phase 3
Completed NCT02193204 - Chronic Alcohol, Stress Inflammatory Response and Relapse Risk N/A
Completed NCT01165541 - A Study of Quetiapine and Mirtazapine for the Treatment of Alcohol Dependency Phase 2
Completed NCT01176591 - HBPL Study of the Impact of the NK1 Antagonist Aprepitant Phase 2
Completed NCT00585780 - Prazosin to Reduce Stress-Induced Alcohol/Drug Craving and Relapse Phase 1/Phase 2
Completed NCT01056484 - Mindfulness Meditation for Health Phase 2
Completed NCT00607620 - Disseminating Organizational SBI Services at Trauma Centers N/A
Completed NCT00884884 - Aripiprazole and Topiramate on Free-Choice Alcohol Use Phase 2/Phase 3
Completed NCT00463346 - Treatment With Acamprosate in Patients With Schizophrenia and Comorbid Alcoholism Phase 3
Completed NCT00226694 - Alcohol and Gender Effects on Stress Circuit Function N/A