HealthyNCT04032587

Modification of Pavlovian and Instrumental Learning in Human Addiction

A study testing Modified training version of the Approach / Avoidance Task (AAT, see Wiers et al., 2011) and Mindfulness-based interventions (e.g. body scan) in people with Healthy and Alcohol Use Disorder (Mild vs. Moderate to Heavy), run by Charite University, Berlin, Germany at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Healthy, Alcohol Use Disorder (Mild vs. Moderate to Heavy)
What is being tested?: Modified training version of the Approach / Avoidance Task (AAT, see Wiers et al., 2011) and Mindfulness-based interventions (e.g. body scan)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteGermany
Study dates: 1 Oct 2019to 30 Jun 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

Dept. of Psychiatry, CCM, Charite Universitätsmedizin Berlin
Berlin, 10117

Other trials in Germany

About this study

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

Read the 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).

Conditions: Healthy, Alcohol Use Disorder (Mild vs. Moderate to Heavy)
Being tested: Modified training version of the Approach / Avoidance Task (AAT, see Wiers et al., 2011), Mindfulness-based interventions (e.g. body scan)
Keywords: approach / avoidance, alcohol use disorder, stress, stress reduction, goal-directed decision-making
Medical subject headings: Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Modified training version of the Approach / Avoidance Task (AAT, see Wiers et al., 2011)Behavioural
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).
Mindfulness-based interventions (e.g. body scan)Behavioural
Acute stress reduction will be applied in a standardized way using audio files with an anticipated duration of 20-30 minutes.

Study groups in NCT04032587
Study group	Role	What they receive
Non-treatment seeking subjects with Alcohol Use Disorder	Experimental	AUD; mild vs. moderate to heavy Receives: Behavioral: Modified training version of the Approach / Avoidance Task (AAT, see Wiers et al., 2011); Behavioral: Mindfulness-based interventions (e.g. body scan)
Healthy Controls	Active comparator	Not described Receives: Behavioral: Modified training version of the Approach / Avoidance Task (AAT, see Wiers et al., 2011); Behavioral: Mindfulness-based interventions (e.g. body scan)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 201930 Jun 2023

First posted25 Jul 2019
Study start1 Oct 2019
Primary completion30 Jun 2023
Study completion30 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04032587
Sponsor's protocol ID: TRR265 C02
Status last verified: Jan 2024
First submitted: 18 Jul 2019
Last updated: 26 Jan 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 19560123
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.
PubMed 22868938
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.
PubMed 30217552
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.
PubMed 28491495
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.
PubMed 25142177
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.
PubMed 29176580
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.
PubMed 24367675
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.
PubMed 24240601
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.
PubMed 24754423
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.
PubMed 26435383

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Modification of Pavlovian and Instrumental Learning in Human Addiction
ClinicalTrials.gov ID: NCT04032587
Acronym / sponsor ID: TRR265 C02
Conditions: Healthy, Alcohol Use Disorder (Mild vs. Moderate to Heavy)
Keywords: approach / avoidance, alcohol use disorder, stress, stress reduction, goal-directed decision-making
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Charite University, Berlin, GermanyUniversity, hospital or other
Study start: 1 Oct 2019 (actual)
Primary completion: 30 Jun 2023 (actual)
Study completion: 30 Jun 2023 (actual)
First posted: 25 Jul 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

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

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Modified training version of the Approach / Avoidance Task (AAT, see Wiers et al., 2011)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).	Behavioural	Healthy Controls, Non-treatment seeking subjects with Alcohol Use Disorder
Mindfulness-based interventions (e.g. body scan)Acute stress reduction will be applied in a standardized way using audio files with an anticipated duration of 20-30 minutes.	Behavioural	Healthy Controls, Non-treatment seeking subjects with Alcohol Use Disorder

Primary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
Background: PubMed 19560123Beck 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.
Background: PubMed 22868938Beck 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.
Background: PubMed 30217552Beck 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.
Background: PubMed 28491495Beylergil 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.
Background: PubMed 25142177Friedel 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.
Background: PubMed 29176580Genauck 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.
Background: PubMed 24367675Koehler 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.
Background: PubMed 24240601Koehler 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.
Background: PubMed 24754423Romanczuk-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.
Background: PubMed 26435383Seo 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood Oxygen Level Dependent especially within the ventral striatum and the amygdala (fMRI) (time frame: 2 consecutive days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04032587, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2024.