Modification of Cue Reactivity by Neurofeedback in Human Addiction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2023-06-30

Brief Summary

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The project is geared towards the understanding of how to increase cognitive control over cue reactivity and drug craving.

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Detailed Description

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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

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Alcohol Use Disorder (AUD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

The participants will be allocated to one of two NFB groups (real NFB or control group) in a double-blind procedure.

Participants of both groups will be further sub-divided into a mindfulness-based relapse prevention (MBRP) and a TAU group (single-blind).

Study Groups

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NFB + (MBRP)

Neurofeedback (NFB) from target region or control region plus Mindfulness-based relapse prevention (for some)

Group Type EXPERIMENTAL

Treatment as usual (TAU) and neurofeedback (NFB)

Intervention Type BEHAVIORAL

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 NFB

Intervention Type BEHAVIORAL

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.

MBT and sham NFB

Intervention Type BEHAVIORAL

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.

TAU and sham NFB

TAU + Neurofeedback (NFB) from control region

Group Type ACTIVE_COMPARATOR

TAU and sham NFB

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

mindfulness-based relapse prevention (MBRP) and NFB

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.

Intervention Type BEHAVIORAL

TAU and sham NFB

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.

Intervention Type BEHAVIORAL

MBT and sham NFB

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No