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Modification of Pavlovian and Instrumental Learning in Human Addiction

Primary Purpose

Healthy, Alcohol Use Disorder (Mild vs. Moderate to Heavy)

Status

Recruiting

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

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

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

About this trial

This is an interventional treatment trial for Healthy focused on measuring approach / avoidance, alcohol use disorder, stress, stress reduction, goal-directed decision-making

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Men and women aged 16-32 years, 33-49 years, and aged 50-65 years
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
Ability to provide fully informed consent and to use self-rating scales
Willingness to use an android phone
Sufficient understanding of the German language

Exclusion Criteria:

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.
Current threshold DSM-5 diagnosis of major depressive disorder, or presence of suicidal intention
History of severe head trauma or other severe central nervous system disorder (e.g., dementia, Parkinson's disease, multiple sclerosis)
Pregnancy or nursing infants
Current use of medications or drugs known to interact with the CNS within at least four half-life post last intake

Sites / Locations

Dept. of Psychiatry, CCM, Charite Universitätsmedizin BerlinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Non-treatment seeking subjects with Alcohol Use Disorder

Healthy Controls

Arm Description

AUD; mild vs. moderate to heavy

Outcomes

Primary Outcome Measures

Blood Oxygen Level Dependent especially within the ventral striatum and the amygdala (fMRI)

Rate of Pavlovian-to-instrumental-Transfer (instrumental responding, i.e.number of button presses, in dependence of Pavlovian Stimuli)

Rate of goal-directed decision-making/habitual decision making

Secondary Outcome Measures

Full Information

NCT ID

NCT04032587

First Posted

July 18, 2019

Last Updated

February 8, 2023

Sponsor

Charite University, Berlin, Germany

1. Study Identification

Unique Protocol Identification Number

NCT04032587

Brief Title

Modification of Pavlovian and Instrumental Learning in Human Addiction

Official Title

Modification of Pavlovian and Instrumental Learning in Human Addiction

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2019 (Actual)

Primary Completion Date

June 30, 2023 (Anticipated)

Study Completion Date

June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Charite University, Berlin, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy, Alcohol Use Disorder (Mild vs. Moderate to Heavy)

Keywords

approach / avoidance, alcohol use disorder, stress, stress reduction, goal-directed decision-making

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Non-treatment seeking subjects with Alcohol Use Disorder

Arm Type

Experimental

Arm Description

AUD; mild vs. moderate to heavy

Arm Title

Healthy Controls

Arm Type

Active Comparator

Intervention Type

Behavioral

Intervention Name(s)

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

Intervention Description

First, a modified training version of the Approach Avoidance Task, (see Wiers et al. 2011) with arbitrary Pavlovian cues will be developed and the effectiveness of this manipulation will be assessed. In detail, positive as well as negative Pavlovian cues (derived from a Pavlovian-to-Instrumental transfer Task, see Garbusow et al. 2014, Garbusow et al. 2016) will be modified according to their approach/ avoidance propensities by 1) approaching negative stimuli (pulling joystick), 2) approaching positive stimuli (pulling joystick), 3) avoiding negative stimuli (pushing joystick) and 4) avoiding positive stimuli (pushing joystick). Thus, we aim at reversing the PIT effect (pushing positive cues/ pulling negative cues) or enhancing the PIT effect (pulling positive cues/ pushing negative cues).

Intervention Type

Behavioral

Intervention Name(s)

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

Intervention Description

Acute stress reduction will be applied in a standardized way using audio files with an anticipated duration of 20-30 minutes.

Primary Outcome Measure Information:

Title

Blood Oxygen Level Dependent especially within the ventral striatum and the amygdala (fMRI)

Time Frame

2 consecutive days

Title

Rate of Pavlovian-to-instrumental-Transfer (instrumental responding, i.e.number of button presses, in dependence of Pavlovian Stimuli)

Time Frame

2 consecutive days

Title

Rate of goal-directed decision-making/habitual decision making

Time Frame

2 consecutive days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men and women aged 16-32 years, 33-49 years, and aged 50-65 years 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 Ability to provide fully informed consent and to use self-rating scales Willingness to use an android phone Sufficient understanding of the German language Exclusion Criteria: 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. Current threshold DSM-5 diagnosis of major depressive disorder, or presence of suicidal intention History of severe head trauma or other severe central nervous system disorder (e.g., dementia, Parkinson's disease, multiple sclerosis) Pregnancy or nursing infants Current use of medications or drugs known to interact with the CNS within at least four half-life post last intake

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anne Beck, Dr. rer. medic.

Phone

+49 30 450 517 194

anne.beck@charite.de

First Name & Middle Initial & Last Name or Official Title & Degree

Nina Romanczuk-Seiferth, Dr. rer. medic.

Phone

+49 30 450 517 027

nina.seiferth@charite.de

Facility Information:

Facility Name

Dept. of Psychiatry, CCM, Charite Universitätsmedizin Berlin

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andreas Heinz, Prof.

Phone

0049 30 450 517002

andreas.heinz@charite.de

12. IPD Sharing Statement

Citations:

PubMed Identifier

19560123

Citation

Beck A, Schlagenhauf F, Wustenberg T, Hein J, Kienast T, Kahnt T, Schmack K, Hagele C, Knutson B, Heinz A, Wrase J. Ventral striatal activation during reward anticipation correlates with impulsivity in alcoholics. Biol Psychiatry. 2009 Oct 15;66(8):734-42. doi: 10.1016/j.biopsych.2009.04.035. Epub 2009 Jun 27.

Results Reference

background

PubMed Identifier

22868938

Citation

Beck A, Wustenberg T, Genauck A, Wrase J, Schlagenhauf F, Smolka MN, Mann K, Heinz A. Effect of brain structure, brain function, and brain connectivity on relapse in alcohol-dependent patients. Arch Gen Psychiatry. 2012 Aug;69(8):842-52. doi: 10.1001/archgenpsychiatry.2011.2026.

Results Reference

background

PubMed Identifier

30217552

Citation

Beck A, Pelz P, Lorenz RC, Charlet K, Geisel O, Heinz A, Wustenberg T, Muller CA. Effects of high-dose baclofen on cue reactivity in alcohol dependence: A randomized, placebo-controlled pharmaco-fMRI study. Eur Neuropsychopharmacol. 2018 Nov;28(11):1206-1216. doi: 10.1016/j.euroneuro.2018.08.507. Epub 2018 Sep 11.

Results Reference

background

PubMed Identifier

28491495

Citation

Beylergil SB, Beck A, Deserno L, Lorenz RC, Rapp MA, Schlagenhauf F, Heinz A, Obermayer K. Dorsolateral prefrontal cortex contributes to the impaired behavioral adaptation in alcohol dependence. Neuroimage Clin. 2017 Apr 17;15:80-94. doi: 10.1016/j.nicl.2017.04.010. eCollection 2017.

Results Reference

background

PubMed Identifier

25142177

Citation

Friedel E, Schlagenhauf F, Beck A, Dolan RJ, Huys QJ, Rapp MA, Heinz A. The effects of life stress and neural learning signals on fluid intelligence. Eur Arch Psychiatry Clin Neurosci. 2015 Feb;265(1):35-43. doi: 10.1007/s00406-014-0519-3. Epub 2014 Aug 21.

Results Reference

background

PubMed Identifier

29176580

Citation

Genauck A, Quester S, Wustenberg T, Morsen C, Heinz A, Romanczuk-Seiferth N. Reduced loss aversion in pathological gambling and alcohol dependence is associated with differential alterations in amygdala and prefrontal functioning. Sci Rep. 2017 Nov 24;7(1):16306. doi: 10.1038/s41598-017-16433-y.

Results Reference

background

PubMed Identifier

24367675

Citation

Koehler S, Ovadia-Caro S, van der Meer E, Villringer A, Heinz A, Romanczuk-Seiferth N, Margulies DS. Increased functional connectivity between prefrontal cortex and reward system in pathological gambling. PLoS One. 2013 Dec 19;8(12):e84565. doi: 10.1371/journal.pone.0084565. eCollection 2013. Erratum In: PLoS One. 2015;10(7):e0134179.

Results Reference

background

PubMed Identifier

24240601

Citation

Koehler S, Hasselmann E, Wustenberg T, Heinz A, Romanczuk-Seiferth N. Higher volume of ventral striatum and right prefrontal cortex in pathological gambling. Brain Struct Funct. 2015 Jan;220(1):469-77. doi: 10.1007/s00429-013-0668-6. Epub 2013 Nov 16.

Results Reference

background

PubMed Identifier

24754423

Citation

Romanczuk-Seiferth N, Koehler S, Dreesen C, Wustenberg T, Heinz A. Pathological gambling and alcohol dependence: neural disturbances in reward and loss avoidance processing. Addict Biol. 2015 May;20(3):557-69. doi: 10.1111/adb.12144. Epub 2014 Apr 22.

Results Reference

background

PubMed Identifier

26435383

Citation

Seo S, Mohr J, Beck A, Wustenberg T, Heinz A, Obermayer K. Predicting the future relapse of alcohol-dependent patients from structural and functional brain images. Addict Biol. 2015 Nov;20(6):1042-55. doi: 10.1111/adb.12302. Epub 2015 Oct 4.

Results Reference

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Modification of Pavlovian and Instrumental Learning in Human Addiction

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