Modification of Pavlovian and Instrumental Learning in Human Addiction

Charité University Medicine Berlin

Status: Completed

Conditions: Healthy; Alcohol Use Disorder (Mild vs. Moderate to Heavy)

Treatments: Behavioral: Modified training version of the Approach / Avoidance Task (AAT, see Wiers et al., 2011); Behavioral: Mindfulness-based interventions (e.g. body scan)

Study type: Interventional

Funder types: Other

Identifiers

NCT04032587

TRR265 C02

Details and patient eligibility

About

The project aims at investigating modifications of environmental factors (i.e. cues and stress) relevant for learning mechanisms in addictive disorders.

Full description

Project C02 aims at investigating modifications of environmental factors (i.e. cues and stress) relevant for learning mechanisms in addictive disorders. The investigators will examine non-treatment seeking subjects with alcohol use disorder (AUD; mild vs. moderate to heavy), and healthy controls with a focus on the impact of Pavlovian conditioned stimuli (context-related cues) on instrumental behavior (so-called Pavlovian-to-Instrumental transfer (PIT)) and whether the PIT effect can be systematically modified by manipulating the approach/ avoidance propensities of Pavlovian cues (work package (WP) 1). Concerning stress as a major modulator of cue reactivity in addiction, the investigators further plan to assess whether acute, active stress reduction modifies such PIT effects (i.e. decreasing transfer effects) as well as goal-directed vs. habitual behavior (i.e. strengthening goal-directed decisionmaking) (WP2). Lastly, this project aims at contributing to the understanding of the underlying neurobiological correlates of manipulation of approach/ avoidance propensities of Pavlovian cues and acute stress reduction by using functional magnetic resonance imaging (WP3) with a focus on amygdala-striatal activity (PIT) and frontostriatal processes (goaldirected decision-making).

Enrollment: 80 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Men and women aged 16-32 years, 33-49 years, and aged 50-65 years
2. Mild, moderate to heavy alcohol-use disorder (AUD) according to DSM-5 criteria (mild: 2-3 AUD criteria; moderate: 4-5 AUD criteria; heavy: 6 or more AUD criteria); not clinically requiring detoxification (as confirmed by an independent board-certified psychiatrist); AUD patients can have mild to moderate cannabis use disorder as well as tobacco use disorder
3. Ability to provide fully informed consent and to use self-rating scales
4. Willingness to use an android phone
5. Sufficient understanding of the German language

Exclusion criteria

1. Lifetime history of DSM-5 bipolar disorder, schizophrenia or schizophrenia spectrum disorder, or substance dependence other than alcohol or nicotine or cannabis dependence. Severe alcohol and cannabis use disorder will be excluded.
2. Current threshold DSM-5 diagnosis of major depressive disorder, or presence of suicidal intention
3. History of severe head trauma or other severe central nervous system disorder (e.g., dementia, Parkinson's disease, multiple sclerosis)
4. Pregnancy or nursing infants
5. Current use of medications or drugs known to interact with the CNS within at least four half-life post last intake

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Non-treatment seeking subjects with Alcohol Use Disorder

Experimental group

Description:

AUD; mild vs. moderate to heavy

Treatment:

Behavioral: Mindfulness-based interventions (e.g. body scan)

Behavioral: Modified training version of the Approach / Avoidance Task (AAT, see Wiers et al., 2011)

Healthy Controls

Active Comparator group

Treatment:

Behavioral: Mindfulness-based interventions (e.g. body scan)

Behavioral: Modified training version of the Approach / Avoidance Task (AAT, see Wiers et al., 2011)