Alcohol Use Disorder (AUD)ReCoDeNCT06701500
Assessing Habitual, Goal-Directed, and Pavlovian Influences in Alcohol Use Disorder
An observational study of Alcohol Use Disorder (AUD) and Alcoholism, run by Technische Universität Dresden at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder (AUD), Alcoholism, Substance Use Disorders
- What is being tested?
- Pavlovian-to-instrumental transfer (PIT) paradigm, Action Sequence Task (AST) and Basic psychological assessment (interview)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 180 participants
- Where
- 1 siteGermany
- Study dates
- 2 Mar 2024to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants recruited through the addiction in- and outpatient clinic of University Hospital Dresden as well as from our partner clinic in Radebeul.
Who may be able to join
- 18-65 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Psychiatry and Psychotherapy, Technische Universität Dresden
Dresden
Michael Smolka, Prof. Dr., +49 351 463-42201, michael.smolka@tu-dresden.de
Maximilian Pilhatsch, Prof. Dr.
About this study
Official title: SFB TRR 265: Losing and Regaining Control Over Drug Intake Project B03: Role of Pavlovian Mechanisms for Control Over Substance Use Project B09: Maladaptive Context Inference As Key Mechanism Underlying Impaired Control
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.
Read the detailed description
This project has three research aims:
- Investigate whether stronger habitual behavior and increased susceptibility to the conflict between habitual and goal-directed control are associated with SUD
- Investigate whether PIT is more of a habitual or a goal-directed process.
- Replicate the previous findings that moderate to severely dependent AUD patients show a stronger PIT effect in contrast to the control group The experiment will be conducted in 90 AUD patients and 90 age and gender-matched controls. Participants will perform the AST task over two consecutive days, and during the second day, they will also perform the single-lever PIT task. In the AST, 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.
The single-lever PIT task consists of four phases. In the instrumental task, participants need to learn which shells to collect or leave in order to gain as much money as possible; the correct choice is probabilistically rewarded in 80% of all times. During the Pavlovian conditioning phase, colorful fractals are presented in the back of the screen, which have been passively paired either with monetary loss, no change or monetary gain, i.e. they act as positively valued, neutral or negatively valued cues. During the transfer phase, participants were instructed to perform the instrumental task as they have done previously. These fractals thus act as independent, Pavlovian conditioned background stimuli and interact with instrumental behavior in the unrelated task to collect the correct shells. To avoid further learning, this transfer part will be conducted under nominal extinction. Finally, query trials, in which one of two pictures will have to be chosen, will be used to assess the relative cue value.
The participants will additionally perform a Counting Stroop task and a No-go Simon task. In the Stroop task, either one, two, three or four identical digits from 1 to 4 are shown. Number and denotation of digits are either congruent (1, 22, 333, 4444; 80 trials) or incongruent (111, 2222, 3, 44; 80 trials). Subjects have to indicate how many digits were shown. In the No-go Simon task, the investigators will show arrows either pointing to the left or right. The arrow can either be shown on the left or the right side of the display. In congruent trials, direction and position are the same, whereas they differ in incongruent trials. Participants have to indicate the direction of the arrow and ignore the position. 20% of trials are No-go trials, indicated by bold arrows. Here subjects have to always withhold a response (inhibition task).
Expected results:
Hypothesis a: The investigators hypothesize an increased habitual tendency and susceptibility to conflict, i.e. interference between habitual and goal-directed control as assessed with the AST in AUD participants. More specifically, the investigators hypothesize that the AUD participants will perform the fixed sequence faster and with fewer errors on the second day of AST. Moreover, in contrast to the control group, AUD participants will choose the high reward keys less often in incongruent trials (when the goals-directed control and the habitual action sequence are in conflict with each other), indicating a shift from goal-directed to habitual control.
Hypothesis b: Given that the allocation of top-down control is needed for overcoming interference by Pavlovian cues and exhibiting more goal-directed control, the investigators expect that participants with stronger PIT effect (lower interference control) also acquire habits more easily and show increased habitual control. Additionally, the investigators hypothesize that the participants with a higher PIT effect will exhibit a shift from goal-directed to habitual control, as indicated by a lower frequency of high reward keys in incongruent trials. As a general process, these associations should be observable in both, the AUD and the control group.
Hypothesis c: As a replication, the investigators expect the AUD group to show a stronger PIT effect in contrast to the control group.
Hypothesis d: Both Interference costs (i.e. increased ER in instrumental responses) during PIT and interference costs between goal-directed and habitual behavior will be associated with interference costs at the stimulus level (Stroop task) and at the response level (No-go Simon task), and these costs will also be correlated with the ER during response inhibition (No-go Simon task).
- Being tested
- Pavlovian-to-instrumental transfer (PIT) paradigm, Action Sequence Task (AST), Basic psychological assessment (interview), Basic psychological assessment (questionnaires), Neuropsychology tests
- Keywords
- Substance use disorder (SUD), Alcohol use disorder (AUD), Outcome-specific Pavlovian to instrumental transfer, Humans, Surveys and Questionnaires, Reward, Cues, Habit formation, Goal-directed behavior
- Medical subject headings
- Alcoholism, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pavlovian-to-instrumental transfer (PIT) paradigmBehavioural
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.
Action Sequence Task (AST)Behavioural
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.
Basic psychological assessment (interview)Diagnostic test
- 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
Basic psychological assessment (questionnaires)Diagnostic test
- 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)
Neuropsychology testsBehavioural
- Digit-Symbol-Test (DST)
- Go/Nogo Simon task
- Counting Stroop Task
- Value-based decision-making task (VBDM)
| Study group | Role | What they receive |
|---|---|---|
| Alcohol Use Disorder (AUD) Group | Participants with alcohol use disorder (moderate to severe if no withdrawal symptoms) Receives: Behavioral: Pavlovian-to-instrumental transfer (PIT) paradigm; Behavioral: Action Sequence Task (AST); Diagnostic Test: Basic psychological assessment (interview); Diagnostic Test: Basic psychological assessment (questionnaires); Behavioral: Neuropsychology tests | |
| Control Group | Participants without SUD Receives: Behavioral: Pavlovian-to-instrumental transfer (PIT) paradigm; Behavioral: Action Sequence Task (AST); Diagnostic Test: Basic psychological assessment (interview); Diagnostic Test: Basic psychological assessment (questionnaires); Behavioral: Neuropsychology tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 2 days, 1 hour per day
Secondary outcomes (2)
Counting Stroop task
Interference cost at the stimulus level: increased error rate in the incongruent condition as compared with the congruent condition.
Measured: 1 day, 10 minutes
Go-Nogo Simon task
Interference cost at the response level: increased error rate in the incongruent condition as compared with the congruent condition. Response inhibition: error rate during No-go trials.
Measured: 1 day, 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start2 Mar 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use Disorder (AUD)Studies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany, Central Institute of Mental Health, Mannheim
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06701500
- Sponsor's protocol ID
- 40217046123
- Acronym
- ReCoDe
- Status last verified
- Sep 2024
- First submitted
- 25 Sep 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36380640Frolich 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.
PubMed 36711151Kronke 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.
PubMed 26321462Chmielewski 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.
PubMed 27742599
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SFB TRR 265: Losing and Regaining Control Over Drug Intake Project B03: Role of Pavlovian Mechanisms for Control Over Substance Use Project B09: Maladaptive Context Inference As Key Mechanism Underlying Impaired Control
- ClinicalTrials.gov ID
- NCT06701500
- Acronym / sponsor ID
- ReCoDe / 40217046123
- Keywords
- Substance use disorder (SUD), Alcohol use disorder (AUD), Outcome-specific Pavlovian to instrumental transfer, Humans, Surveys and Questionnaires, Reward, Cues, Habit formation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany, Central Institute of Mental Health, Mannheim
- Study start
- 2 Mar 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 22 Nov 2024 (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 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.
Detailed description
This project has three research aims:
- Investigate whether stronger habitual behavior and increased susceptibility to the conflict between habitual and goal-directed control are associated with SUD
- Investigate whether PIT is more of a habitual or a goal-directed process.
- Replicate the previous findings that moderate to severely dependent AUD patients show a stronger PIT effect in contrast to the control group The experiment will be conducted in 90 AUD patients and 90 age and gender-matched controls. Participants will perform the AST task over two consecutive days, and during the second day, they will also perform the single-lever PIT task. In the AST, 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.
The single-lever PIT task consists of four phases. In the instrumental task, participants need to learn which shells to collect or leave in order to gain as much money as possible; the correct choice is probabilistically rewarded in 80% of all times. During the Pavlovian conditioning phase, colorful fractals are presented in the back of the screen, which have been passively paired either with monetary loss, no change or monetary gain, i.e. they act as positively valued, neutral or negatively valued cues. During the transfer phase, participants were instructed to perform the instrumental task as they have done previously. These fractals thus act as independent, Pavlovian conditioned background stimuli and interact with instrumental behavior in the unrelated task to collect the correct shells. To avoid further learning, this transfer part will be conducted under nominal extinction. Finally, query trials, in which one of two pictures will have to be chosen, will be used to assess the relative cue value.
The participants will additionally perform a Counting Stroop task and a No-go Simon task. In the Stroop task, either one, two, three or four identical digits from 1 to 4 are shown. Number and denotation of digits are either congruent (1, 22, 333, 4444; 80 trials) or incongruent (111, 2222, 3, 44; 80 trials). Subjects have to indicate how many digits were shown. In the No-go Simon task, the investigators will show arrows either pointing to the left or right. The arrow can either be shown on the left or the right side of the display. In congruent trials, direction and position are the same, whereas they differ in incongruent trials. Participants have to indicate the direction of the arrow and ignore the position. 20% of trials are No-go trials, indicated by bold arrows. Here subjects have to always withhold a response (inhibition task).
Expected results:
Hypothesis a: The investigators hypothesize an increased habitual tendency and susceptibility to conflict, i.e. interference between habitual and goal-directed control as assessed with the AST in AUD participants. More specifically, the investigators hypothesize that the AUD participants will perform the fixed sequence faster and with fewer errors on the second day of AST. Moreover, in contrast to the control group, AUD participants will choose the high reward keys less often in incongruent trials (when the goals-directed control and the habitual action sequence are in conflict with each other), indicating a shift from goal-directed to habitual control.
Hypothesis b: Given that the allocation of top-down control is needed for overcoming interference by Pavlovian cues and exhibiting more goal-directed control, the investigators expect that participants with stronger PIT effect (lower interference control) also acquire habits more easily and show increased habitual control. Additionally, the investigators hypothesize that the participants with a higher PIT effect will exhibit a shift from goal-directed to habitual control, as indicated by a lower frequency of high reward keys in incongruent trials. As a general process, these associations should be observable in both, the AUD and the control group.
Hypothesis c: As a replication, the investigators expect the AUD group to show a stronger PIT effect in contrast to the control group.
Hypothesis d: Both Interference costs (i.e. increased ER in instrumental responses) during PIT and interference costs between goal-directed and habitual behavior will be associated with interference costs at the stimulus level (Stroop task) and at the response level (No-go Simon task), and these costs will also be correlated with the ER during response inhibition (No-go Simon task).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcohol Use Disorder (AUD) Group | – | Behavioral: Pavlovian-to-instrumental transfer (PIT) paradigm, Behavioral: Action Sequence Task (AST), Diagnostic Test: Basic psychological assessment (interview), Diagnostic Test: Basic psychological assessment (questionnaires), Behavioral: Neuropsychology testsParticipants with alcohol use disorder (moderate to severe if no withdrawal symptoms) |
| Control Group | – | Behavioral: Pavlovian-to-instrumental transfer (PIT) paradigm, Behavioral: Action Sequence Task (AST), Diagnostic Test: Basic psychological assessment (interview), Diagnostic Test: Basic psychological assessment (questionnaires), Behavioral: Neuropsychology testsParticipants without SUD |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants recruited through the addiction in- and outpatient clinic of University Hospital Dresden as well as from our partner clinic in Radebeul.
Key inclusion criteria (5 listed)
- 18-65 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Pavlovian-to-instrumental transfer (PIT) paradigmThe 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. | Behavioural | Alcohol Use Disorder (AUD) Group, Control Group |
| Action Sequence Task (AST)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. | Behavioural | Alcohol Use Disorder (AUD) Group, Control Group |
| Basic psychological assessment (interview)* 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 | Diagnostic test | Alcohol Use Disorder (AUD) Group, Control Group |
| Basic psychological assessment (questionnaires)* 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) | Diagnostic test | Alcohol Use Disorder (AUD) Group, Control Group |
| Neuropsychology tests* Digit-Symbol-Test (DST) * Go/Nogo Simon task * Counting Stroop Task * Value-based decision-making task (VBDM) | Behavioural | Alcohol Use Disorder (AUD) Group, Control Group |
Primary outcome
Behavioral single-lever Pavlovian to instrumental transfer (PIT) effect
Time frame: 1 day, 1 hour
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.
Action Sequence Task (AST) day one and day two
Time frame: 2 days, 1 hour per day
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 secondary outcomes
Counting Stroop task
Time frame: 1 day, 10 minutes
Go-Nogo Simon task
Time frame: 1 day, 20 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Background: PubMed 36380640Belanger 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.
- Background: PubMed 36711151Frolich 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.
- Background: PubMed 26321462Kronke 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.
- Background: PubMed 27742599Chmielewski 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.
- Individual participant dataSharing planned: Undecided
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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.
Department of Psychiatry and Psychotherapy, Technische Universität Dresden
Dresden, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Use Disorder (AUD) and Alcoholism, run by Technische Universität Dresden at 1 site in Germany.
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: looking for participants now, as of the sponsor's last update on 22 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral single-lever Pavlovian to instrumental transfer (PIT) effect (time frame: 1 day, 1 hour). The study lists 2 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 NCT06701500, which also lists 4 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 22 Nov 2024.