Clinical trial NCT04366505: Modification of Cue Reactivity by Neurofeedback in Human Addiction
Official title: Modification of Cue Reactivity by Neurofeedback in Human Addiction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alcohol Use Disorder (AUD)
Keywords: alcohol use disorder
mindfulness-based intervention
neurofeedback
ventral striatum
Lead sponsor: Central Institute of Mental Health, Mannheim
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 88
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Neural Level: Blood Oxygen Level Dependent Signal within the ventral striatum
timeFrame: 3 consecutive days within up to two weeks
measure: Clinical Level: Number of relapses
timeFrame: 3 months
Secondary outcomes:
measure: Functional changes in brain networks
timeFrame: up to two weeks
measure: Drinking type
timeFrame: up to two weeks
measure: Form 90 (Miller, 1996)
timeFrame: up to two weeks
measure: Baratt Impulsiveness Scale (BIS-15) (Meule et al., 2011)
timeFrame: up to two weeks
measure: Sensory Inventory (SI): self-assessment of sensory sensitivity for adults and adolescents (Zamoscik et al., 2017)
timeFrame: up to two weeks
measure: General depression scale (german: "Allgemeine Depressionsskala") (Radloff, 1977)
timeFrame: up to two weeks
measure: Positive and Negative Affect Schedule (PANAS) (Watson et al., 1988)
timeFrame: up to two weeks.
measure: Perceived Stress Scale (PSS) (Cohen et al., 1983)
timeFrame: up to two weeks
measure: Behavioral Inhibition/Approach System (BIS/BAS) (Carver & White, 1994)
timeFrame: up to two weeks
measure: Fagerström Test of Nicotine Dependence (Heatherton et al., 1991)
timeFrame: up to two weeks
measure: Visual Craving Scale
timeFrame: up to two weeks
measure: Vocabulary test
timeFrame: Collected once during the baseline assessment
measure: Dot-probe task with alcohol stimuli
timeFrame: Collected once during the baseline assessment
measure: Dimensional card sorting task (Zelazo, 2006)
timeFrame: Collected once during the baseline assessment
measure: Cue reactivity task (Vollstädt-Klein et al., 2011)
timeFrame: 2 timepoints: Before and after 2 weeks of neurofeedback.
measure: Alcohol Abstinence Self-Efficacy Scale (DiClemente et al., 1994)
timeFrame: 2 weeks
measure: Alcohol Urge Questionnaire (Bohn et al., 1995)
timeFrame: 2 weeks
measure: Alcohol Dependence Scale (Ackermann et al., 1999)
timeFrame: 2 weeks
measure: German Inventory of Drinking Situations (DITS-40) (Victorio-Estrada, 1993)
timeFrame: 2 weeks
measure: Craving Automated Scale for Alcohol (CASA) (Vollstädt-Klein et al., 2015)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Klinische Psychologie + Klinik für Abhängiges Verhalten und Suchtmedizin, Zentralinstitut für Seelische Gesundheit
state: Baden-Württemberg
Study officials:
References:
citation: 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.
citation: DiClemente 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.
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. doi: 10.1111/j.1530-0277.1995.tb01554.x.
citation: Weiss 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.