Modification of Cue Reactivity by Neurofeedback in Human Addiction

Alcohol Use Disorder (AUD) Clinical Trial

Official title:

Modification of Cue Reactivity by Neurofeedback in Human Addiction

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04366505
• Other study ID #: TRR265 C04
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: April 2021
• Source: Central Institute of Mental Health, Mannheim
• Contact: Peter Kirsch, Prof. Dr.
• Phone: +49-621/1703
• Email: peter.kirsch[@]zi-mannheim.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 88
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder (AUD)
• Alcoholism

Intervention

Behavioral:
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Germany	Klinische Psychologie + Klinik für Abhängiges Verhalten und Suchtmedizin, Zentralinstitut für Seelische Gesundheit	Mannheim	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Central Institute of Mental Health, Mannheim

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View Citation

Bohn 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. — View Citation

DiClemente CC, Carbonari JP, Montgomery RP, Hughes SO. The Alcohol Abstinence Self-Efficacy scale. J Stud Alcohol. 1994 Mar;55(2):141-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 consecutive days within up to two weeks
Primary	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.	3 months
Secondary	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.	up to two weeks
Secondary	Drinking type	Short question on which kind of drinking type the participant identifies with the most	up to two weeks
Secondary	Form 90 (Miller, 1996)	Primary dependent measure of alcohol consumption	up to two weeks
Secondary	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.	up to two weeks
Secondary	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.	up to two weeks
Secondary	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.	up to two weeks
Secondary	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.	up to two weeks.
Secondary	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.	up to two weeks
Secondary	Behavioral Inhibition/Approach System (BIS/BAS) (Carver & White, 1994)	assessing individual differences in the sensitivity of the behavioral approach and the behavioral avoidance system.	up to two weeks
Secondary	Fagerström Test of Nicotine Dependence (Heatherton et al., 1991)	assessing nicotine dependence	up to two weeks
Secondary	Visual Craving Scale	Visual Analogue Scale for craving	up to two weeks
Secondary	Vocabulary test	Neuropsychological test	Collected once during the baseline assessment
Secondary	Dot-probe task with alcohol stimuli	Change in attentional bias to alcohol-related cues.	Collected once during the baseline assessment
Secondary	Dimensional card sorting task (Zelazo, 2006)	Neuropsychological test	Collected once during the baseline assessment
Secondary	Cue reactivity task (Vollstädt-Klein et al., 2011)	fMRI task. Change in BOLD during cue reactivity task.	2 timepoints: Before and after 2 weeks of neurofeedback.
Secondary	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.	2 weeks
Secondary	Alcohol Urge Questionnaire (Bohn et al., 1995)	measure of craving	2 weeks
Secondary	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.	2 weeks
Secondary	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.	2 weeks
Secondary	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.	2 weeks