NCT06701500

Brief Summary

The first aim of this study is to establish the role of maladaptive reliance on habits for impaired control in addiction, employing a novel task - the Action-Sequence-Task (AST), which assesses interference between habitual and goal-directed control. The AST, along with the developed computational model, will be employed to test whether participants with Alcohol Use Disorder (AUD) and control participants differ with respect to task performance and estimated model parameters. The investigators hypothesize stronger habitual behavior (increased habitual tendency) and an increased susceptibility to conflict between habitual and goal-directed control, measured as increased interference, are associated with AUD. The second aim of the study is to understand whether Pavlovian-to-Instrumental Transfer (PIT) reflects more of a controlled, goal-directed process, or a more automatic, habitual process. The investigators will use the single-lever PIT task as it is an efficient tool for testing the interaction between Pavlovian cues and instrumental behavior, especially when they are in conflict. In these trials, top-down control must be allocated to successfully overcome the conflict, which may share some common underlying mechanisms with the arbitration between goal-directed and habitual behavior during conflict, as assessed by the novel AST. The third aim of the study is to investigate whether severely dependent AUD patients would show a stronger PIT effect compared to a control group, consistent with the investigators' previous findings.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
14mo left

Started Mar 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Mar 2024Jun 2027

Study Start

First participant enrolled

March 2, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 22, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Expected
Last Updated

November 22, 2024

Status Verified

September 1, 2024

Enrollment Period

1.1 years

First QC Date

September 25, 2024

Last Update Submit

November 19, 2024

Conditions

Keywords

Substance use disorder (SUD)Alcohol use disorder (AUD)Outcome-specific Pavlovian to instrumental transferHumansSurveys and QuestionnairesRewardCuesHabit formationGoal-directed behavior

Outcome Measures

Primary Outcomes (2)

  • Behavioral single-lever Pavlovian to instrumental transfer (PIT) effect

    Strength of interference PIT effect assessed with the single-lever PIT paradigm: increased error rate in the incongruent condition as compared with the congruent condition.

    1 day, 1 hour

  • Action Sequence Task (AST) day one and day two

    Habit formation: faster response time and decreased errors of preforming fixed compared to the random action sequence. Shift from goal-directed to habitual control: less choices of the high reward keys in trials in the incongruent trials where the goal-directed control and the habitual action sequence are in conflict (incongruent trials)

    2 days, 1 hour per day

Secondary Outcomes (2)

  • Counting Stroop task

    1 day, 10 minutes

  • Go-Nogo Simon task

    1 day, 20 minutes

Study Arms (2)

Alcohol Use Disorder (AUD) Group

Participants with alcohol use disorder (moderate to severe if no withdrawal symptoms)

Behavioral: Pavlovian-to-instrumental transfer (PIT) paradigmBehavioral: Action Sequence Task (AST)Diagnostic Test: Basic psychological assessment (interview)Diagnostic Test: Basic psychological assessment (questionnaires)Behavioral: Neuropsychology tests

Control Group

Participants without SUD

Behavioral: Pavlovian-to-instrumental transfer (PIT) paradigmBehavioral: Action Sequence Task (AST)Diagnostic Test: Basic psychological assessment (interview)Diagnostic Test: Basic psychological assessment (questionnaires)Behavioral: Neuropsychology tests

Interventions

The paradigm consists of four parts: In the first part, an instrumental learning task is completed in which subjects must learn which stimuli require a response and which do not. In the second part, a classical (Pavlovian) conditioning task is then completed in which subjects learn by passive viewing which stimuli are associated with certain amounts of money. The third part measures to which instrumental responses (learned in Part 1) are modulated by the presentation of the classically conditioned stimuli (learned in Part 2). At the same time drug-associated stimuli are presented in the background measuring to which extent they conflict with the learned instrumental behavior. In the last part, query trials are implemented in which the participants have to choose between two pictures to assess the relative cue value.

Alcohol Use Disorder (AUD) GroupControl Group

Participants need to press four keys according to the cue location; two keys are associated with high reward, while the other two are associated with low reward in case of correct and timely responses. The explicit goal is to maximize the reward. While in half of the trials the cues are presented in a random order, in the other half of the trials, participants repeatedly perform a fixed action sequence of 12 elements (habit condition). The degree of action sequence chunking (i.e. automation) is assessed via the differences in error rates and reaction times between the random and fixed order condition (habit parameter). Importantly, 15% of all trials are dual- target trials. In these the goal-directed system (press high reward key) and the action sequence (press sequence key) can either be in line (congruent trials) or in conflict (incongruent trials) with each other, thus the interference between goal-directed and habitual control can be tested.

Alcohol Use Disorder (AUD) GroupControl Group

* Structured Clinical Interview for DSM Disorders (SCID) Current Depression: * SCID Mania * SCID alcohol use disorder (AUD) * SCID tobacco use disorder (TUD) * Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) * Alcohol quantity-frequency * Tobacco quantity-frequency * Cannabis and other substances quantity-frequency

Alcohol Use Disorder (AUD) GroupControl Group

* Sociodemographics * Edinburgh Handedness Inventory (EHI) * Fagerström Test for Nicotine depend (FTND) * Barratt Impulsiveness Scale - Kurzversion (BIS-15) * Alcohol Use Disorders Identification Test (AUDIT) * Cannabis Use Disorders Identification Test (CUDIT) * Adult ADHD Self-Report Scale (ASRS)

Alcohol Use Disorder (AUD) GroupControl Group

* Digit-Symbol-Test (DST) * Go/Nogo Simon task * Counting Stroop Task * Value-based decision-making task (VBDM)

Alcohol Use Disorder (AUD) GroupControl Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants recruited through the addiction in- and outpatient clinic of University Hospital Dresden as well as from our partner clinic in Radebeul.

You may qualify if:

  • years of age
  • AUD subjects only: meet 4 or more criteria for DSM-5 alcohol use disorder
  • Sufficient motor skills and visual acuity to use PC
  • Ability to consent to the study and complete the questionnaires
  • Sufficient German skills

You may not qualify if:

  • Lifetime diagnosis of DSM-5 bipolar disorder, schizophrenia or schizophrenia spectrum disorder
  • Current diagnosis of severe major depression according to DSM-5, or presence of suicidal intention
  • Pregnancy
  • Severe withdrawal symptoms
  • Acute drug intoxication at the appointments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry and Psychotherapy, Technische Universität Dresden

Dresden, Germany

RECRUITING

Related Publications (4)

  • Belanger MJ, Chen H, Hentschel A, Garbusow M, Ebrahimi C, Knorr FG, Zech HG, Pilhatsch M, Heinz A, Smolka MN. Development of Novel Tasks to Assess Outcome-Specific and General Pavlovian-to-Instrumental Transfer in Humans. Neuropsychobiology. 2022;81(5):370-386. doi: 10.1159/000526774. Epub 2022 Nov 14.

    PMID: 36380640BACKGROUND
  • Frolich S, Esmeyer M, Endrass T, Smolka MN, Kiebel SJ. Interaction between habits as action sequences and goal-directed behavior under time pressure. Front Neurosci. 2023 Jan 13;16:996957. doi: 10.3389/fnins.2022.996957. eCollection 2022.

    PMID: 36711151BACKGROUND
  • Kronke KM, Wolff M, Benz A, Goschke T. Successful smoking cessation is associated with prefrontal cortical function during a Stroop task: A preliminary study. Psychiatry Res. 2015 Oct 30;234(1):52-6. doi: 10.1016/j.pscychresns.2015.08.005. Epub 2015 Aug 20.

    PMID: 26321462BACKGROUND
  • Chmielewski WX, Beste C. Testing interactive effects of automatic and conflict control processes during response inhibition - A system neurophysiological study. Neuroimage. 2017 Feb 1;146:1149-1156. doi: 10.1016/j.neuroimage.2016.10.015. Epub 2016 Oct 11.

    PMID: 27742599BACKGROUND

MeSH Terms

Conditions

AlcoholismSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2024

First Posted

November 22, 2024

Study Start

March 2, 2024

Primary Completion

March 31, 2025

Study Completion (Estimated)

June 30, 2027

Last Updated

November 22, 2024

Record last verified: 2024-09

Locations