Modification of Pavlovian and Instrumental Learning in Human Addiction

Not Applicable

Completed

• Conditions: Alcohol Use Disorder (Mild vs. Moderate to Heavy); Healthy
• Interventions: Behavioral: Modified training version of the Approach / Avoidance Task (AAT, see Wiers et al., 2011); Behavioral: Mindfulness-based interventions (e.g. body scan)

• Registration Number: NCT04032587
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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

Detailed 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).

Study Timeline

• Study First Submitted: 2019-07-18
• Study First Submitted QC: 2019-07-23
• Study First Posted: 2019-07-25
• Study Start: 2019-10-01
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-25
• Last Update Posted: 2024-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-treatment seeking subjects with Alcohol Use Disorder	Modified training version of the Approach / Avoidance Task (AAT, see Wiers et al., 2011)	AUD; mild vs. moderate to heavy
Non-treatment seeking subjects with Alcohol Use Disorder	Mindfulness-based interventions (e.g. body scan)	AUD; mild vs. moderate to heavy
Healthy Controls	Mindfulness-based interventions (e.g. body scan)	-
Healthy Controls	Modified training version of the Approach / Avoidance Task (AAT, see Wiers et al., 2011)	-

Primary Outcome Measures

Name	Time	Method
Blood Oxygen Level Dependent especially within the ventral striatum and the amygdala (fMRI)	2 consecutive days
Rate of goal-directed decision-making/habitual decision making	2 consecutive days
Rate of Pavlovian-to-instrumental-Transfer (instrumental responding, i.e.number of button presses, in dependence of Pavlovian Stimuli)	2 consecutive days

Trial Locations

Locations (1)

Dept. of Psychiatry, CCM, Charite Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany