Alcohol DependenceNCT02486900
Neurofeedback & Alcohol Dependence
A study testing fMRI-based neurofeedback in people with Alcohol Dependence, run by Cardiff University at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- fMRI-based neurofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2015to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Successful completion of detoxification programme within a time window of 1 to 6 months before the recruitment
- Abstinence since detoxification treatment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
School of Medicine, Cardiff University
Cardiff, Wales, CF14 4XN
About this study
Official title: Real-time fMRI Neurofeedback as a Treatment Tool for Alcohol Dependence
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.
Read the 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).
- Conditions
- Alcohol Dependence
- Being tested
- fMRI-based neurofeedback
- Keywords
- Craving, Cue Reactivity, Neurofeedback
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRI-based neurofeedbackDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Indices of drinking (continuous) - % days abstinent
Derived from the Timeline Followback Calendar.
Measured: 4 months after baseline assessment/first training
Indices of drinking (continuous) - drinks per drinking day
Derived from the Timeline Followback Calendar.
Measured: 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.
Measured: 4 months after baseline assessment/first training
Secondary outcomes (9)
Drinking urges/craving assessed with the Drinking Urges Questionnaire (DUQ)
Measured: Assessed 4 months, 8 months and 12 months after baseline
Drinking urges/craving assessed with the Obsessive Compulsive Drinking Scale (OCDS)
Measured: Assessed 4 months, 8 months and 12 months after baseline
Drinking urges/craving (attentional bias) assessed with the alcohol stroop test
Measured: Assessed 4 months, 8 months and 12 months after baseline
Craving self-ratings during scanning (neurofeedback group only)
Measured: Assessed 2, 4, 6, 8, 12, 16 weeks after baseline (each training session)
Profile of Mood States Questionnaire
Measured: Assessed 4 months, 8 months and 12 months after baseline
Beck Depression Inventory
Measured: Assessed 4 months, 8 months and 12 months after baseline
Hospital Anxiety and Depression Scale
Measured: Assessed 4 months, 8 months and 12 months after baseline
NHS Resource Use Questionnaire
Measured: Assessed 4 months, 8 months and 12 months after baseline
Debriefing Questionnaire (neurofeedback group only)
Measured: Assessed 2, 4, 6, 8, 12, 16 weeks after baseline (each training session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startSep 2015
- Primary completionJan 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiff University
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission
- Responsible party
- Principal investigator, David Linden, Cardiff University
- Investigators
- David Linden, MD, Principal investigator, Cardiff University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02486900
- Sponsor's protocol ID
- BRAINTRAINAD
- Status last verified
- Jan 2019
- First submitted
- 26 Jun 2015
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27716290
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time fMRI Neurofeedback as a Treatment Tool for Alcohol Dependence
- ClinicalTrials.gov ID
- NCT02486900
- Acronym / sponsor ID
- BRAINTRAINAD
- Conditions
- Alcohol Dependence
- Keywords
- Craving, Cue Reactivity, Neurofeedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Cardiff UniversityUniversity, hospital or other
- Collaborators
- European Commission
- Study start
- Sep 2015
- Primary completion
- Jan 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 1 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback training group | Experimental | Device: fMRI-based neurofeedbackThe 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. |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Successful completion of detoxification programme within a time window of 1 to 6 months before the recruitment
- Abstinence since detoxification treatment
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fMRI-based neurofeedbackDuring 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. | Device | Neurofeedback training group |
Primary outcome
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.
9 secondary outcomes
Drinking urges/craving assessed with the Drinking Urges Questionnaire (DUQ)
Time frame: Assessed 4 months, 8 months and 12 months after baseline
Drinking urges/craving assessed with the Obsessive Compulsive Drinking Scale (OCDS)
Time frame: Assessed 4 months, 8 months and 12 months after baseline
Drinking urges/craving (attentional bias) assessed with the alcohol stroop test
Time frame: Assessed 4 months, 8 months and 12 months after baseline
Craving self-ratings during scanning (neurofeedback group only)
Time frame: Assessed 2, 4, 6, 8, 12, 16 weeks after baseline (each training session)
Profile of Mood States Questionnaire
Time frame: Assessed 4 months, 8 months and 12 months after baseline
Beck Depression Inventory
Time frame: Assessed 4 months, 8 months and 12 months after baseline
Hospital Anxiety and Depression Scale
Time frame: Assessed 4 months, 8 months and 12 months after baseline
NHS Resource Use Questionnaire
Time frame: Assessed 4 months, 8 months and 12 months after baseline
Debriefing Questionnaire (neurofeedback group only)
Time frame: Assessed 2, 4, 6, 8, 12, 16 weeks after baseline (each training session)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
- Derived from this study: PubMed 27716290Cox 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Linden, MD principal investigator
Cardiff University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fMRI-based neurofeedback in people with Alcohol Dependence, run by Cardiff University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Indices of drinking (continuous) - % days abstinent (time frame: 4 months after baseline assessment/first training). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02486900, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2019.