Alcohol Use Disorder (AUD)NCT04366505
Modification of Cue Reactivity by Neurofeedback in Human Addiction
A study testing Treatment as usual (TAU) and neurofeedback (NFB) and mindfulness-based relapse prevention (MBRP) and NFB in people with Alcohol Use Disorder (AUD), run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
Trial summary
The project is geared towards the understanding of how to increase cognitive control over cue reactivity and drug craving. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Alcohol Use Disorder (AUD)
- What is being tested?
- Treatment as usual (TAU) and neurofeedback (NFB) and mindfulness-based relapse prevention (MBRP) and NFB
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2021to 30 Jun 2023
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- alcohol use disorder according to DSM-5
- ability to provide fully informed consent and to use self-rating scales
- abstinent after detoxification for at least 5 days
- sufficient understanding of the German language
Who cannot join
- lifetime history of DSM-5 bipolar, psychotic disorder, or substance dependence other than alcohol or nicotine dependence
- current substance use other than nicotine and/or mild to moderate recreational use of cannabis as evidenced by positive urine test
- current threshold DSM-5 diagnosis of any of the following disorders: current (hypo)manic episode, major depressive disorder, generalized anxiety disorder, PTSD, borderline personality disorder, or obsessive compulsive disorder
- history of severe head trauma or other severe central neurological disorders (dementia, Parkinson's disease, multiple sclerosis)
- pregnancy or nursing infants
- use of medications or drugs known to interact with the CNS within the last 10 days, with testing at least four half-lives post last intake
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinische Psychologie + Klinik für Abhängiges Verhalten und Suchtmedizin, Zentralinstitut für Seelische Gesundheit
Mannheim, Baden-Wurttemberg, 68159
About this study
The project is geared towards the understanding of how to increase cognitive control over cue reactivity and drug craving.
Read the detailed description
Project C04 aims at assessing the combined effect of two interventions targeting at reducing striatal cue reactivity and increasing cognitive control, namely mindfulness-based intervention and real-time fMRI neurofeedback. Firstly, the investigators will test whether a prior mindfulness-based intervention (WP1) is able to enhance the effect of rtfMRI NFB (WP2) and change the networks involved in regulation of cue reactivity by providing participants with explicit strategies. Secondly, the investigators will investigate whether this combined intervention leads to a better clinical outcome in terms of decreased heavy drinking days and a reduced sum of alcohol consumption three months later.
- Conditions
- Alcohol Use Disorder (AUD)
- Being tested
- Treatment as usual (TAU) and neurofeedback (NFB), mindfulness-based relapse prevention (MBRP) and NFB, TAU and sham NFB, MBT and sham NFB
- Keywords
- alcohol use disorder, mindfulness-based intervention, neurofeedback, ventral striatum
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment as usual (TAU) and neurofeedback (NFB)Behavioural
This group will receive Treatment as usual (TAU) and neurofeedback (NFB). During NFB, participants will be asked to regulate the signal from a target brain region during the presentation of alcohol cues. The ventral striatum was chosen as target region.
mindfulness-based relapse prevention (MBRP) and NFBBehavioural
This group will receive MBRP and neurofeedback (NFB). MBRP consists of 5 extensive sessions of a specific manualized mindfulness-based intervention for alcohol dependent patients which will be carried out by trained psychologists and psychotherapists. During NFB, participants will be asked to regulate the signal from a target brain region during the presentation of alcohol cues. The ventral striatum was chosen as a target region.
TAU and sham NFBBehavioural
This group will receive TAU and sham NFB. Sham NFB means that the signal displayed to the participant is based on activity in a control region, the auditory cortex, which is not involved in cue reactivity.
MBT and sham NFBBehavioural
This group will receive MBRP and sham NFB. MBRP consists of 5 extensive sessions of a specific manualized mindfulness-based intervention for alcohol dependent patients which will be carried out by trained psychologists and psychotherapists. Sham NFB means that the signal displayed to the participant is based on activity in a control region, the auditory cortex, which is not involved in cue reactivity.
| Study group | Role | What they receive |
|---|---|---|
| NFB + (MBRP) | Experimental | Neurofeedback (NFB) from target region or control region plus Mindfulness-based relapse prevention (for some) Receives: Behavioral: Treatment as usual (TAU) and neurofeedback (NFB); Behavioral: mindfulness-based relapse prevention (MBRP) and NFB; Behavioral: MBT and sham NFB |
| TAU and sham NFB | Active comparator | TAU + Neurofeedback (NFB) from control region Receives: Behavioral: TAU and sham NFB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural Level: Blood Oxygen Level Dependent Signal within the ventral striatum
Change of the ability to volitionally modulate brain activation to alcohol cues after training in the target area.
Measured: 3 consecutive days within up to two weeks
Clinical Level: Number of relapses
MBT and NFB will each lead to a reduced number of relapses during three months after treatment in comparison to the combination of TAU and sham NFB. The combined intervention is expected to lead to a larger reduction compared to the other groups. The investigators expect a higher number of days until relapse, a lower number of heavy drinking days and a lower amount of alcohol consumed by the participants during the follow-up period showing similar group differences.
Measured: 3 months
Secondary outcomes (20)
Functional changes in brain networks
Functional changes in brain networks related to cognitive control during cognitive task performance between baseline and post-neurofeedback fMRI sessions.
Measured: up to two weeks
Drinking type
Short question on which kind of drinking type the participant identifies with the most
Measured: up to two weeks
Form 90 (Miller, 1996)
Primary dependent measure of alcohol consumption
Measured: up to two weeks
Baratt Impulsiveness Scale (BIS-15) (Meule et al., 2011)
Questionnaire assessing personality/behavioral construct of impulsivity. Scores range from 15 to 60. The BIS-15 has a four-point rating scale with a minimum value of 1 (1 = seldom/never) to a maximum of 4 (4 = almost always/always). Lower scores indicate less impulsivity and higher score mean more impulsivity.
Measured: up to two weeks
Sensory Inventory (SI): self-assessment of sensory sensitivity for adults and adolescents (Zamoscik et al., 2017)
Questionnaire on self-assessment of sensory sensitivity. Minimum value: 1 representing "never". maximum value: 7 representing "almost always". Higher scores indicate higher sensitivity for sensory influences.
Measured: up to two weeks
General depression scale (german: "Allgemeine Depressionsskala") (Radloff, 1977)
Self-assessment of depressive symptoms. minimum: 0 representing "seldom", maximum: 3 representing "mostly". Higher scores indicate stronger depression.
Measured: up to two weeks
Positive and Negative Affect Schedule (PANAS) (Watson et al., 1988)
measures mood/emotion. minimum: 1 representing "not at all", maximum: 5 representing "very much". Depending on the item, higher scores represent higher levels of positive affect and lower scores represent lower levels of negative affect.
Measured: up to two weeks.
Perceived Stress Scale (PSS) (Cohen et al., 1983)
measures stress. minimum: 1 representing "never". maximum: 5 representing "quite often". Higher scores indicate higher levels of perceived stress.
Measured: up to two weeks
Behavioral Inhibition/Approach System (BIS/BAS) (Carver & White, 1994)
assessing individual differences in the sensitivity of the behavioral approach and the behavioral avoidance system.
Measured: up to two weeks
Fagerström Test of Nicotine Dependence (Heatherton et al., 1991)
assessing nicotine dependence
Measured: up to two weeks
Visual Craving Scale
Visual Analogue Scale for craving
Measured: up to two weeks
Vocabulary test
Neuropsychological test
Measured: Collected once during the baseline assessment
Dot-probe task with alcohol stimuli
Change in attentional bias to alcohol-related cues.
Measured: Collected once during the baseline assessment
Dimensional card sorting task (Zelazo, 2006)
Neuropsychological test
Measured: Collected once during the baseline assessment
Cue reactivity task (Vollstädt-Klein et al., 2011)
fMRI task. Change in BOLD during cue reactivity task.
Measured: 2 timepoints: Before and after 2 weeks of neurofeedback.
Alcohol Abstinence Self-Efficacy Scale (DiClemente et al., 1994)
measure of craving. minimum: 1 representing "not at all", maximum: 5 representing "enormous". Higher scores indicate a high perceived temptation to drink.
Measured: 2 weeks
Alcohol Urge Questionnaire (Bohn et al., 1995)
measure of craving
Measured: 2 weeks
Alcohol Dependence Scale (Ackermann et al., 1999)
measure of craving. Range/response options vary depending on the question. Higher scores are predictive of DSM diagnosis of alcohol dependence.
Measured: 2 weeks
German Inventory of Drinking Situations (DITS-40) (Victorio-Estrada, 1993)
measure of craving. minimum: 0 representing "never", maximum: 3 representing "almost always". Higher scores indicate a higher frequency to drink.
Measured: 2 weeks
Craving Automated Scale for Alcohol (CASA) (Vollstädt-Klein et al., 2015)
measure of craving. minimum: 0 representing "never", maximum: 5 representing "always". Higher scores indicate automated craving.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start1 Jul 2021 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use Disorder (AUD)Studies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Institute of Mental Health, Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366505
- Sponsor's protocol ID
- TRR265 C04
- Status last verified
- Apr 2021
- First submitted
- 30 Mar 2020
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to data protection rules, individual data cannot be shared. Cumulated data on the group level can be made available for meta-analyses on request.
Publications
Anton RF, Moak DH, Latham P. The Obsessive Compulsive Drinking Scale: a self-rated instrument for the quantification of thoughts about alcohol and drinking behavior. Alcohol Clin Exp Res. 1995 Feb;19(1):92-9. doi: 10.1111/j.1530-0277.1995.tb01475.x.
PubMed 7771669DiClemente CC, Carbonari JP, Montgomery RP, Hughes SO. The Alcohol Abstinence Self-Efficacy scale. J Stud Alcohol. 1994 Mar;55(2):141-8. doi: 10.15288/jsa.1994.55.141.
PubMed 8189734Bohn MJ, Krahn DD, Staehler BA. Development and initial validation of a measure of drinking urges in abstinent alcoholics. Alcohol Clin Exp Res. 1995 Jun;19(3):600-6. doi: 10.1111/j.1530-0277.1995.tb01554.x.
PubMed 7573780Weiss F, Aslan A, Zhang J, Gerchen MF, Kiefer F, Kirsch P. Using mind control to modify cue-reactivity in AUD: the impact of mindfulness-based relapse prevention on real-time fMRI neurofeedback to modify cue-reactivity in alcohol use disorder: a randomized controlled trial. BMC Psychiatry. 2020 Jun 16;20(1):309. doi: 10.1186/s12888-020-02717-7.
PubMed 32546139
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modification of Cue Reactivity by Neurofeedback in Human Addiction
- ClinicalTrials.gov ID
- NCT04366505
- Acronym / sponsor ID
- TRR265 C04
- Conditions
- Alcohol Use Disorder (AUD)
- Keywords
- alcohol use disorder, mindfulness-based intervention, neurofeedback, ventral striatum
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Central Institute of Mental Health, MannheimUniversity, hospital or other
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 29 Apr 2020 (actual)
- 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 project is geared towards the understanding of how to increase cognitive control over cue reactivity and drug craving.
Detailed description
Project C04 aims at assessing the combined effect of two interventions targeting at reducing striatal cue reactivity and increasing cognitive control, namely mindfulness-based intervention and real-time fMRI neurofeedback. Firstly, the investigators will test whether a prior mindfulness-based intervention (WP1) is able to enhance the effect of rtfMRI NFB (WP2) and change the networks involved in regulation of cue reactivity by providing participants with explicit strategies. Secondly, the investigators will investigate whether this combined intervention leads to a better clinical outcome in terms of decreased heavy drinking days and a reduced sum of alcohol consumption three months later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NFB + (MBRP) | Experimental | Behavioral: Treatment as usual (TAU) and neurofeedback (NFB), Behavioral: mindfulness-based relapse prevention (MBRP) and NFB, Behavioral: MBT and sham NFBNeurofeedback (NFB) from target region or control region plus Mindfulness-based relapse prevention (for some) |
| TAU and sham NFB | Active comparator | Behavioral: TAU and sham NFBTAU + Neurofeedback (NFB) from control region |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- alcohol use disorder according to DSM-5
- ability to provide fully informed consent and to use self-rating scales
- abstinent after detoxification for at least 5 days
- sufficient understanding of the German language
Key exclusion criteria (6 listed)
- lifetime history of DSM-5 bipolar, psychotic disorder, or substance dependence other than alcohol or nicotine dependence
- current substance use other than nicotine and/or mild to moderate recreational use of cannabis as evidenced by positive urine test
- current threshold DSM-5 diagnosis of any of the following disorders: current (hypo)manic episode, major depressive disorder, generalized anxiety disorder, PTSD, borderline personality disorder, or obsessive compulsive disorder
- history of severe head trauma or other severe central neurological disorders (dementia, Parkinson's disease, multiple sclerosis)
- pregnancy or nursing infants
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 |
|---|---|---|
| Treatment as usual (TAU) and neurofeedback (NFB)This group will receive Treatment as usual (TAU) and neurofeedback (NFB). During NFB, participants will be asked to regulate the signal from a target brain region during the presentation of alcohol cues. The ventral striatum was chosen as target region. | Behavioural | NFB + (MBRP) |
| mindfulness-based relapse prevention (MBRP) and NFBThis group will receive MBRP and neurofeedback (NFB). MBRP consists of 5 extensive sessions of a specific manualized mindfulness-based intervention for alcohol dependent patients which will be carried out by trained psychologists and psychotherapists. During NFB, participants will be asked to regulate the signal from a target brain region during the presentation of alcohol cues. The ventral striatum was chosen as a target region. | Behavioural | NFB + (MBRP) |
| TAU and sham NFBThis group will receive TAU and sham NFB. Sham NFB means that the signal displayed to the participant is based on activity in a control region, the auditory cortex, which is not involved in cue reactivity. | Behavioural | TAU and sham NFB |
| MBT and sham NFBThis group will receive MBRP and sham NFB. MBRP consists of 5 extensive sessions of a specific manualized mindfulness-based intervention for alcohol dependent patients which will be carried out by trained psychologists and psychotherapists. Sham NFB means that the signal displayed to the participant is based on activity in a control region, the auditory cortex, which is not involved in cue reactivity. | Behavioural | NFB + (MBRP) |
Primary outcome
Neural Level: Blood Oxygen Level Dependent Signal within the ventral striatum
Time frame: 3 consecutive days within up to two weeks
Change of the ability to volitionally modulate brain activation to alcohol cues after training in the target area.
Clinical Level: Number of relapses
Time frame: 3 months
MBT and NFB will each lead to a reduced number of relapses during three months after treatment in comparison to the combination of TAU and sham NFB. The combined intervention is expected to lead to a larger reduction compared to the other groups. The investigators expect a higher number of days until relapse, a lower number of heavy drinking days and a lower amount of alcohol consumed by the participants during the follow-up period showing similar group differences.
20 secondary outcomes
Functional changes in brain networks
Time frame: up to two weeks
Drinking type
Time frame: up to two weeks
Form 90 (Miller, 1996)
Time frame: up to two weeks
Baratt Impulsiveness Scale (BIS-15) (Meule et al., 2011)
Time frame: up to two weeks
Sensory Inventory (SI): self-assessment of sensory sensitivity for adults and adolescents (Zamoscik et al., 2017)
Time frame: up to two weeks
General depression scale (german: "Allgemeine Depressionsskala") (Radloff, 1977)
Time frame: up to two weeks
Positive and Negative Affect Schedule (PANAS) (Watson et al., 1988)
Time frame: up to two weeks.
Perceived Stress Scale (PSS) (Cohen et al., 1983)
Time frame: up to two weeks
Behavioral Inhibition/Approach System (BIS/BAS) (Carver & White, 1994)
Time frame: up to two weeks
Fagerström Test of Nicotine Dependence (Heatherton et al., 1991)
Time frame: up to two weeks
Visual Craving Scale
Time frame: up to two weeks
Vocabulary test
Time frame: Collected once during the baseline assessment
Dot-probe task with alcohol stimuli
Time frame: Collected once during the baseline assessment
Dimensional card sorting task (Zelazo, 2006)
Time frame: Collected once during the baseline assessment
Cue reactivity task (Vollstädt-Klein et al., 2011)
Time frame: 2 timepoints: Before and after 2 weeks of neurofeedback.
Alcohol Abstinence Self-Efficacy Scale (DiClemente et al., 1994)
Time frame: 2 weeks
Alcohol Urge Questionnaire (Bohn et al., 1995)
Time frame: 2 weeks
Alcohol Dependence Scale (Ackermann et al., 1999)
Time frame: 2 weeks
German Inventory of Drinking Situations (DITS-40) (Victorio-Estrada, 1993)
Time frame: 2 weeks
Craving Automated Scale for Alcohol (CASA) (Vollstädt-Klein et al., 2015)
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Background: PubMed 7771669Anton RF, Moak DH, Latham P. The Obsessive Compulsive Drinking Scale: a self-rated instrument for the quantification of thoughts about alcohol and drinking behavior. Alcohol Clin Exp Res. 1995 Feb;19(1):92-9. doi: 10.1111/j.1530-0277.1995.tb01475.x.
- Background: PubMed 8189734DiClemente CC, Carbonari JP, Montgomery RP, Hughes SO. The Alcohol Abstinence Self-Efficacy scale. J Stud Alcohol. 1994 Mar;55(2):141-8. doi: 10.15288/jsa.1994.55.141.
- Background: PubMed 7573780Bohn MJ, Krahn DD, Staehler BA. Development and initial validation of a measure of drinking urges in abstinent alcoholics. Alcohol Clin Exp Res. 1995 Jun;19(3):600-6. doi: 10.1111/j.1530-0277.1995.tb01554.x.
- Derived from this study: PubMed 32546139Weiss F, Aslan A, Zhang J, Gerchen MF, Kiefer F, Kirsch P. Using mind control to modify cue-reactivity in AUD: the impact of mindfulness-based relapse prevention on real-time fMRI neurofeedback to modify cue-reactivity in alcohol use disorder: a randomized controlled trial. BMC Psychiatry. 2020 Jun 16;20(1):309. doi: 10.1186/s12888-020-02717-7.
- Individual participant dataSharing planned: No. Due to data protection rules, individual data cannot be shared. Cumulated data on the group level can be made available for meta-analyses on request.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment as usual (TAU) and neurofeedback (NFB) and mindfulness-based relapse prevention (MBRP) and NFB in people with Alcohol Use Disorder (AUD), run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 28 Apr 2021. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Kirsch, Prof. Dr. (+49-621/1703 ext. 6501, peter.kirsch@zi-mannheim.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neural Level: Blood Oxygen Level Dependent Signal within the ventral striatum (time frame: 3 consecutive days within up to two weeks). The study lists 2 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 NCT04366505, which also lists 4 linked publications.
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 28 Apr 2021.