Alcohol Use DisorderReCoDeNCT06256952
Effect of Social Isolation on the Role of Pavlovian Mechanisms for Control Over Alcohol Use
A study testing PIT paradigm, social exclusion (Cyberball task) and Saliva samples in people with Alcohol Use Disorder and Alcoholism, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
During the first funding period (1st FP) we investigated the impact of acute and chronic stress (Trier Social Stress Test, TSST) on Pavlovian-to-instrumental transfer (PIT). Moreover, we developed a novel full transfer task that allows assessing both general and specific PIT to investigate whether specific PIT differs… 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, Alcoholism, Stress Reaction
- What is being tested?
- PIT paradigm, social exclusion (Cyberball task) and Saliva samples
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2024to 30 Jun 2027
- Phase
- Interventional
- 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
Who may be able to join
- Males and females between 18-65 years of age,
- AUD subjects: meet 4 or more criteria for DSM-5 alcohol-use disorder (not requiring withdrawal as assessed by an independent psychiatrist),
- Currently using alcohol without a desire for abstinence,
- Ability to consent to the study and complete the questionnaires.
- Sufficient language skills: German
- Availability between 3pm-6pm on 2 consecutive days,
- existing health insurance
Who cannot join
- Lifetime diagnosis according to DMS-5 for a: Bipolar disorder, schizophrenia, schizophrenia spectrum disorder, substance dependence except for alcohol, nicotine, cannabis, and/or methamphetamine
- Currently meeting DSM-5 diagnostic criteria for depressive episode, suicidal ideation,
- History of traumatic brain injury or severe neurological disease (such as dementia, Parkinson's disease, multiple sclerosis)
- Pregnancy or breastfeeding,
- Ingestion of medications known to interact with the CNS in the 10-day period prior to study participation or less than 4 half-lives after last ingestion (rapid urine test),
- Color vision deficiency
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
Charite - Universitätsmedizin Berlin
Berlin, 10117
Andreas Heinz, Prof.,MD,PhD, +49 30 450 517 001, andreas.heinz@charite.de
Michael N. Smolka, Prof.,MD,PhD, +49 351 463 42201, michael.smolka@tu-dresden.de
About this study
Official title: SFB TRR 265: Losing and Regaining Control Over Drug Intake B03: Role of Pavlovian Mechanisms for Control Over Substance Use WP2: Effects of Social Isolation on PIT in AUD
During the first funding period (1st FP) we investigated the impact of acute and chronic stress (Trier Social Stress Test, TSST) on Pavlovian-to-instrumental transfer (PIT). Moreover, we developed a novel full transfer task that allows assessing both general and specific PIT to investigate whether specific PIT differs between alcohol use disorder (AUD) and control subjects. We found that our online version of TSST induced stress and thereby amplified PIT effects in participants. Preliminary analyses of the full transfer task indicate that AUD participants exhibit a stronger specific PIT effect compared to controls. Based on these findings, we want to assess the following aim for this study:
Investigate the effect of experimentally induced social exclusion on alcohol-specific and general PIT effects in AUD and control participants.
Read the detailed description
The projects research aim:
The investigators will examine how an experimentally induced social exclusion by the Cyberball task is associated with alcohol specific and general PIT effects by using the newly developed full transfer task from 1st funding period in AUD vs. HCs.
The investigators will use the newly developed full PIT paradigm to examine the modifying effect of experimentally induced social exclusion stress on alcohol-specific and general PIT effects. While using the Trier Social Stress Test in the 1st FP, the investigators now want to go one step further by including social exclusion/ostracism to the stress component, which has not been studied in association with PIT effects yet. The investigators here want to shed light on possible underlying mechanisms which can lead to a promotion of alcohol-seeking by alcohol-stimuli in situations of social exclusion.
Participants (50 AUD and 50 HC) will be assessed at two time points, once after experimentally induced social exclusion and once after social inclusion in a fully balanced, cross-over within-subject design. Subjects will play an online game tossing a ball to each other with two more virtual co-players (Cyberball). Using a cover story, we make subjects believe that the co-players really exist and that they play a live online game. During social exclusion, subjects will be systematically excluded by one co-player (partial exclusion), and during social inclusion, ball tosses will be balanced between all three players. Cyberball usually induces feelings of social isolation and altered behavioral reactions in the subject, which the investigators want to assess by analyzing ball tossing behavior over time, as well as physiological and subjective measures (concentration of cortisol in saliva, heart rate variability and emotions questionnaires, such as the Need to Belong Scale, Rejection Sensitivity Questionnaire, Need threat scale and Positive and Negative Affect Schedule pre and post Cyberball game and after PIT). After the Cyberball experiment, subjects will undergo the transfer part of the full PIT task (using a parallel version at one of the two days in a randomized order).
Hypothesis 1a:
Social exclusion will lead to a stronger stress hormone response (concentration of cortisol in saliva), lower heart rate variability and a stronger general PIT effect compared to social inclusion (main effect social exclusion intervention on PIT).
Hypothesis 1b:
Stronger social exclusion effects in AUD subjects compared to controls will lead to stronger PIT effects compared to social inclusion (interaction effect between group and stress intervention on PIT), especially for alcohol-specific PIT.
- Being tested
- PIT paradigm, social exclusion (Cyberball task), Saliva samples, basic psychological assessment, pre and post cyberball task
- Keywords
- Substance use disorder (SUD), Alcohol use disorder (AUD), General and outcome-specific Pavlovian to instrumental transfer, Social exclusion, Humans, Surveys and Questionnaires, Reward, Cues
- Medical subject headings
- Alcoholism, Fractures, Stress, Ostracism, Substance-Related Disorders, Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
social exclusion (Cyberball task)Behavioural
Social exclusion will be assessed using the cyberball paradigm: subjects will play an online game tossing a ball to each other with two more virtual co-players. Using a cover story, we make subjects believe that the co-players really exist and that they play a live online game. During social exclusion, subjects will be systematically excluded by one co-player, and during social inclusion, ball tosses will be balanced between all three players.
Saliva samplesDiagnostic test
Assessing acute stress effects in AUD and HC subjects
basic psychological assessmentDiagnostic test
- Sociodemographics
- ASSIST
- Quantity Frequency: Alcohol, tobacco/e-cigarette, Cannabis \& other illegal drugs
- SCID: AUD criteria and tabak use disorder life time and last year \& acute depressive symptoms \& symptoms for Mania and psychotic disorder
- Edinburgh Handedness Inventory (EHI)
- Fagerström Test for Nicotine depend (FTND)
- Barratt Impulsiveness Scale - Kurzversion (BIS-15)
- Allgemeine Depressionsskala (ADS)
- State-Trait-Anxiety Inventory (STAI-T)
- Alcohol Use Disorders Identification Test (AUDIT)
- Cannabis Use Disorder Identification Test (CUDIT)
- CAS -A (Alkohol)
- Fragebogen zur Sozialen Unterstützung (F-SozU K-14)
- Oslo-3-Items-Social-Support Scale
- Social Skills Rating System (SSRS)
- Trier Inventory for chronic stress (TICS)
- Rejection Sensitivity Questionnaires (RSQ-9)
- Need to belong scale (NTBS)
- Fragebogen zu Gedanken und Gefühlen (FGG-14)
- Internationale Trauma Questionnaire (ITQ)
- Zahlen-Symbol-Test (DST)
- Wortschatztest (verbal intelligence)
pre and post cyberball taskDiagnostic test
Positive and Negative Affect Schedule(PANAS)
VASDiagnostic test
subjective arousal, subjective stress, valence, perceived ostracisms/loneliness
after cyberball taskDiagnostic test
- Need Threat Scale
- Manipulation check (VAS scale)
social inclusion (Cyberball task)Behavioural
Social inclusion will be assessed using the cyberball paradigm: subjects will play an online game tossing a ball to each other with two more virtual co-players. Using a cover story, we make subjects believe that the co-players really exist and that they play a live online game. During social inclusion, ball tosses will be balanced between all three players.
| Study group | Role | What they receive |
|---|---|---|
| Control (HC) - exclusion first | Experimental | Healthy participants without SUD Cyberball: Exclusion Day 1; Cyberball: Inclusion Day 2 Receives: Behavioral: PIT paradigm; Behavioral: social exclusion (Cyberball task); Diagnostic Test: Saliva samples; Diagnostic Test: basic psychological assessment; Diagnostic Test: pre and post cyberball task; Diagnostic Test: VAS; Diagnostic Test: after cyberball task; Behavioral: social inclusion (Cyberball task) |
| Control (HC) - inclusion first | Experimental | Healthy participants without SUD Cyberball: Inclusion Day 1; Cyberball: Exclusion Day 2 Receives: Behavioral: PIT paradigm; Behavioral: social exclusion (Cyberball task); Diagnostic Test: Saliva samples; Diagnostic Test: basic psychological assessment; Diagnostic Test: pre and post cyberball task; Diagnostic Test: VAS; Diagnostic Test: after cyberball task; Behavioral: social inclusion (Cyberball task) |
| Moderate to sever alcohol users (AUD) - exclusion first | Experimental | Participants with alcohol use disorder (moderate to severe if no withdrawal symptoms) and no other substance use disorder (SUD) Cyberball: Exclusion Day 1; Cyberball: Inclusion Day 2 Receives: Behavioral: PIT paradigm; Behavioral: social exclusion (Cyberball task); Diagnostic Test: Saliva samples; Diagnostic Test: basic psychological assessment; Diagnostic Test: pre and post cyberball task; Diagnostic Test: VAS; Diagnostic Test: after cyberball task; Behavioral: social inclusion (Cyberball task) |
| Moderate to sever alcohol users (AUD) - inclusion first | Experimental | Participants with alcohol use disorder (moderate to severe if no withdrawal symptoms) and no other substance use disorder (SUD) Cyberball: Inclusion Day 1; Cyberball: Exclusion Day 2 Receives: Behavioral: PIT paradigm; Behavioral: social exclusion (Cyberball task); Diagnostic Test: Saliva samples; Diagnostic Test: basic psychological assessment; Diagnostic Test: pre and post cyberball task; Diagnostic Test: VAS; Diagnostic Test: after cyberball task; Behavioral: social inclusion (Cyberball task) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral full-lever specific and general PIT (parallel version) effect day one
Specific:
Average percentage of alcohol choice difference during the presentation of alcohol or non-alcohol pavlovian background.
General:
Differences in number of button presses during the presentation of positive (+10 Euro) and negative (-10 Euro) pavlovian backgrounds.
Measured: Day 1
Behavioral full-lever specific and general PIT (parallel version) effect day two
Specific:
Average percentage of alcohol choice difference during the presentation of alcohol or non-alcohol pavlovian background.
General:
Differences in number of button presses during the presentation of positive (+10 Euro) and negative (-10 Euro) pavlovian backgrounds.
Measured: Day 2
Social exclusion/inclusion induced using Cyberball Game
experimentally-induced social exclusion stress by using the cyberball paradigm: Subjects will play an online game tossing a ball to each other with two more virtual co-players. Using a cover story, we make subjects believe that the co-players really exist and that they play a live online game. During social exclusion, subjects will be systematically excluded by one co-player (partial exclusion), and during social inclusion, ball tosses will be balanced between all three players. Effects of the Cyberball manipulation (social exclusion/inclusion) will be assessed via ratings in Positive and Negative Affect Scale (PANAS) and Need-Threat-Scale (NTS).
Measured: Day 1
Social exclusion/inclusion induced using Cyberball Game
experimentally-induced social exclusion stress by using the cyberball paradigm: Subjects will play an online game tossing a ball to each other with two more virtual co-players. Using a cover story, we make subjects believe that the co-players really exist and that they play a live online game. During social exclusion, subjects will be systematically excluded by one co-player (partial exclusion), and during social inclusion, ball tosses will be balanced between all three players. Effects of the Cyberball manipulation (social exclusion/inclusion) will be assessed via ratings in Positive and Negative Affect Scale (PANAS) and Need-Threat-Scale (NTS).
Measured: Day 2
Secondary outcomes (4)
Concentration of cortisol in saliva
[Time Frame: Assessment before, during and after Cyberball game (T1: arrival of subject), T2: right before Cyberball game, T3: right after Cyberball game, T4: after PIT part 3 and T5: at the end of testing day)]
Measured: Day 1 and Day 2
Positive and Negative Affect Schedule (PANAS)
Scale 1-5, for PA (positive affect) and NA (negative affect) higher scores indicate higher positive and negative affect
Measured: Baseline and after Cyberball Experiment on Day 1 and Day 2
Need Threat Scale (NTS)
Scale from 1 to 5, high scores indicate high needs in Belonging, Control, Meaningful existence and self-esteem
Measured: After Cyberball Experiment on Day 1 and Day 2
Heart rate variability
Measured: At baseline 5 min AND During experimental part (social inclusion or exclusion) 5 min Day 1 and Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start1 Oct 2024 (estimated)
- Primary completion30 Jun 2027 (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 (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study employs a within-group design. The participants of each group (AUD and HC) attend two consecutive sessions (one a day), and on each of these days, they engage in the Cyberball Experiment before undertaking the PIT Task. Within the Cyberball Experiment, participants are randomly assigned to either partial exclusion or inclusion on the first day. On the second consecutive day, they undergo the condition they did not experience previously.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Heidelberg University, Zentralinstitut für Seelische Gesundheit Mannheim, Technische Universität Dresden
- Responsible party
- Principal investigator, Andreas Heinz, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256952
- Sponsor's protocol ID
- 40217046122
- Acronym
- ReCoDe
- Status last verified
- Aug 2024
- First submitted
- 11 Jan 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Roayaee M, Rahman RA, Danziger M, Tudge L, Daedelow LS, Heinz A, Wustenberg T. [The others and I: How social interactions change the perception of other persons. The Cyberball paradigm and its indications in the migration context]. Fortschr Neurol Psychiatr. 2020 Feb;88(2):109-117. doi: 10.1055/a-1033-7304. Epub 2020 Feb 26. German.
PubMed 32102102Staebler K, Helbing E, Rosenbach C, Renneberg B. Rejection sensitivity and borderline personality disorder. Clin Psychol Psychother. 2011 Jul-Aug;18(4):275-83. doi: 10.1002/cpp.705. Epub 2010 May 25.
PubMed 21110407
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 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 B03: Role of Pavlovian Mechanisms for Control Over Substance Use WP2: Effects of Social Isolation on PIT in AUD
- ClinicalTrials.gov ID
- NCT06256952
- Acronym / sponsor ID
- ReCoDe / 40217046122
- Keywords
- Substance use disorder (SUD), Alcohol use disorder (AUD), General and outcome-specific Pavlovian to instrumental transfer, Social exclusion, Humans, Surveys and Questionnaires, Reward, Cues
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Heidelberg University, Zentralinstitut für Seelische Gesundheit Mannheim, Technische Universität Dresden
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 13 Feb 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.
During the first funding period (1st FP) we investigated the impact of acute and chronic stress (Trier Social Stress Test, TSST) on Pavlovian-to-instrumental transfer (PIT). Moreover, we developed a novel full transfer task that allows assessing both general and specific PIT to investigate whether specific PIT differs between alcohol use disorder (AUD) and control subjects. We found that our online version of TSST induced stress and thereby amplified PIT effects in participants. Preliminary analyses of the full transfer task indicate that AUD participants exhibit a stronger specific PIT effect compared to controls. Based on these findings, we want to assess the following aim for this study:
Investigate the effect of experimentally induced social exclusion on alcohol-specific and general PIT effects in AUD and control participants.
Detailed description
The projects research aim:
The investigators will examine how an experimentally induced social exclusion by the Cyberball task is associated with alcohol specific and general PIT effects by using the newly developed full transfer task from 1st funding period in AUD vs. HCs.
The investigators will use the newly developed full PIT paradigm to examine the modifying effect of experimentally induced social exclusion stress on alcohol-specific and general PIT effects. While using the Trier Social Stress Test in the 1st FP, the investigators now want to go one step further by including social exclusion/ostracism to the stress component, which has not been studied in association with PIT effects yet. The investigators here want to shed light on possible underlying mechanisms which can lead to a promotion of alcohol-seeking by alcohol-stimuli in situations of social exclusion.
Participants (50 AUD and 50 HC) will be assessed at two time points, once after experimentally induced social exclusion and once after social inclusion in a fully balanced, cross-over within-subject design. Subjects will play an online game tossing a ball to each other with two more virtual co-players (Cyberball). Using a cover story, we make subjects believe that the co-players really exist and that they play a live online game. During social exclusion, subjects will be systematically excluded by one co-player (partial exclusion), and during social inclusion, ball tosses will be balanced between all three players. Cyberball usually induces feelings of social isolation and altered behavioral reactions in the subject, which the investigators want to assess by analyzing ball tossing behavior over time, as well as physiological and subjective measures (concentration of cortisol in saliva, heart rate variability and emotions questionnaires, such as the Need to Belong Scale, Rejection Sensitivity Questionnaire, Need threat scale and Positive and Negative Affect Schedule pre and post Cyberball game and after PIT). After the Cyberball experiment, subjects will undergo the transfer part of the full PIT task (using a parallel version at one of the two days in a randomized order).
Hypothesis 1a:
Social exclusion will lead to a stronger stress hormone response (concentration of cortisol in saliva), lower heart rate variability and a stronger general PIT effect compared to social inclusion (main effect social exclusion intervention on PIT).
Hypothesis 1b:
Stronger social exclusion effects in AUD subjects compared to controls will lead to stronger PIT effects compared to social inclusion (interaction effect between group and stress intervention on PIT), especially for alcohol-specific PIT.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- The study employs a within-group design. The participants of each group (AUD and HC) attend two consecutive sessions (one a day), and on each of these days, they engage in the Cyberball Experiment before undertaking the PIT Task. Within the Cyberball Experiment, participants are randomly assigned to either partial exclusion or inclusion on the first day. On the second consecutive day, they undergo the condition they did not experience previously.
| Arm | Type | Receives |
|---|---|---|
| Control (HC) - exclusion first | Experimental | Behavioral: PIT paradigm, Behavioral: social exclusion (Cyberball task), Diagnostic Test: Saliva samples, Diagnostic Test: basic psychological assessment, Diagnostic Test: pre and post cyberball task, Diagnostic Test: VAS, Diagnostic Test: after cyberball task, Behavioral: social inclusion (Cyberball task)Healthy participants without SUD Cyberball: Exclusion Day 1; Cyberball: Inclusion Day 2 |
| Control (HC) - inclusion first | Experimental | Behavioral: PIT paradigm, Behavioral: social exclusion (Cyberball task), Diagnostic Test: Saliva samples, Diagnostic Test: basic psychological assessment, Diagnostic Test: pre and post cyberball task, Diagnostic Test: VAS, Diagnostic Test: after cyberball task, Behavioral: social inclusion (Cyberball task)Healthy participants without SUD Cyberball: Inclusion Day 1; Cyberball: Exclusion Day 2 |
| Moderate to sever alcohol users (AUD) - exclusion first | Experimental | Behavioral: PIT paradigm, Behavioral: social exclusion (Cyberball task), Diagnostic Test: Saliva samples, Diagnostic Test: basic psychological assessment, Diagnostic Test: pre and post cyberball task, Diagnostic Test: VAS, Diagnostic Test: after cyberball task, Behavioral: social inclusion (Cyberball task)Participants with alcohol use disorder (moderate to severe if no withdrawal symptoms) and no other substance use disorder (SUD) Cyberball: Exclusion Day 1; Cyberball: Inclusion Day 2 |
| Moderate to sever alcohol users (AUD) - inclusion first | Experimental | Behavioral: PIT paradigm, Behavioral: social exclusion (Cyberball task), Diagnostic Test: Saliva samples, Diagnostic Test: basic psychological assessment, Diagnostic Test: pre and post cyberball task, Diagnostic Test: VAS, Diagnostic Test: after cyberball task, Behavioral: social inclusion (Cyberball task)Participants with alcohol use disorder (moderate to severe if no withdrawal symptoms) and no other substance use disorder (SUD) Cyberball: Inclusion Day 1; Cyberball: Exclusion Day 2 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females between 18-65 years of age,
- AUD subjects: meet 4 or more criteria for DSM-5 alcohol-use disorder (not requiring withdrawal as assessed by an independent psychiatrist),
- Currently using alcohol without a desire for abstinence,
- Ability to consent to the study and complete the questionnaires.
- Sufficient language skills: German
Key exclusion criteria (6 listed)
- Lifetime diagnosis according to DMS-5 for a: Bipolar disorder, schizophrenia, schizophrenia spectrum disorder, substance dependence except for alcohol, nicotine, cannabis, and/or methamphetamine
- Currently meeting DSM-5 diagnostic criteria for depressive episode, suicidal ideation,
- History of traumatic brain injury or severe neurological disease (such as dementia, Parkinson's disease, multiple sclerosis)
- Pregnancy or breastfeeding,
- Ingestion of medications known to interact with the CNS in the 10-day period prior to study participation or less than 4 half-lives after last ingestion (rapid urine test),
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 |
|---|---|---|
| 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 | Control (HC) - exclusion first, Control (HC) - inclusion first, Moderate to sever alcohol users (AUD) - exclusion first, Moderate to sever alcohol users (AUD) - inclusion first |
| social exclusion (Cyberball task)Social exclusion will be assessed using the cyberball paradigm: subjects will play an online game tossing a ball to each other with two more virtual co-players. Using a cover story, we make subjects believe that the co-players really exist and that they play a live online game. During social exclusion, subjects will be systematically excluded by one co-player, and during social inclusion, ball tosses will be balanced between all three players. | Behavioural | Control (HC) - exclusion first, Control (HC) - inclusion first, Moderate to sever alcohol users (AUD) - exclusion first, Moderate to sever alcohol users (AUD) - inclusion first |
| Saliva samplesAssessing acute stress effects in AUD and HC subjects | Diagnostic test | Control (HC) - exclusion first, Control (HC) - inclusion first, Moderate to sever alcohol users (AUD) - exclusion first, Moderate to sever alcohol users (AUD) - inclusion first |
| basic psychological assessment* Sociodemographics * ASSIST * Quantity Frequency: Alcohol, tobacco/e-cigarette, Cannabis \& other illegal drugs * SCID: AUD criteria and tabak use disorder life time and last year \& acute depressive symptoms \& symptoms for Mania and psychotic disorder * Edinburgh Handedness Inventory (EHI) * Fagerström Test for Nicotine depend (FTND) * Barratt Impulsiveness Scale - Kurzversion (BIS-15) * Allgemeine Depressionsskala (ADS) * State-Trait-Anxiety Inventory (STAI-T) * Alcohol Use Disorders Identification Test (AUDIT) * Cannabis Use Disorder Identification Test (CUDIT) * CAS -A (Alkohol) * Fragebogen zur Sozialen Unterstützung (F-SozU K-14) * Oslo-3-Items-Social-Support Scale * Social Skills Rating System (SSRS) * Trier Inventory for chronic stress (TICS) * Rejection Sensitivity Questionnaires (RSQ-9) * Need to belong scale (NTBS) * Fragebogen zu Gedanken und Gefühlen (FGG-14) * Internationale Trauma Questionnaire (ITQ) * Zahlen-Symbol-Test (DST) * Wortschatztest (verbal intelligence) | Diagnostic test | Control (HC) - exclusion first, Control (HC) - inclusion first, Moderate to sever alcohol users (AUD) - exclusion first, Moderate to sever alcohol users (AUD) - inclusion first |
| pre and post cyberball taskPositive and Negative Affect Schedule(PANAS) | Diagnostic test | Control (HC) - exclusion first, Control (HC) - inclusion first, Moderate to sever alcohol users (AUD) - exclusion first, Moderate to sever alcohol users (AUD) - inclusion first |
| VASsubjective arousal, subjective stress, valence, perceived ostracisms/loneliness | Diagnostic test | Control (HC) - exclusion first, Control (HC) - inclusion first, Moderate to sever alcohol users (AUD) - exclusion first, Moderate to sever alcohol users (AUD) - inclusion first |
| after cyberball task* Need Threat Scale * Manipulation check (VAS scale) | Diagnostic test | Control (HC) - exclusion first, Control (HC) - inclusion first, Moderate to sever alcohol users (AUD) - exclusion first, Moderate to sever alcohol users (AUD) - inclusion first |
| social inclusion (Cyberball task)Social inclusion will be assessed using the cyberball paradigm: subjects will play an online game tossing a ball to each other with two more virtual co-players. Using a cover story, we make subjects believe that the co-players really exist and that they play a live online game. During social inclusion, ball tosses will be balanced between all three players. | Behavioural | Control (HC) - exclusion first, Control (HC) - inclusion first, Moderate to sever alcohol users (AUD) - exclusion first, Moderate to sever alcohol users (AUD) - inclusion first |
Primary outcome
Behavioral full-lever specific and general PIT (parallel version) effect day one
Time frame: Day 1
Specific: Average percentage of alcohol choice difference during the presentation of alcohol or non-alcohol pavlovian background. General: Differences in number of button presses during the presentation of positive (+10 Euro) and negative (-10 Euro) pavlovian backgrounds.
Behavioral full-lever specific and general PIT (parallel version) effect day two
Time frame: Day 2
Specific: Average percentage of alcohol choice difference during the presentation of alcohol or non-alcohol pavlovian background. General: Differences in number of button presses during the presentation of positive (+10 Euro) and negative (-10 Euro) pavlovian backgrounds.
Social exclusion/inclusion induced using Cyberball Game
Time frame: Day 1
experimentally-induced social exclusion stress by using the cyberball paradigm: Subjects will play an online game tossing a ball to each other with two more virtual co-players. Using a cover story, we make subjects believe that the co-players really exist and that they play a live online game. During social exclusion, subjects will be systematically excluded by one co-player (partial exclusion), and during social inclusion, ball tosses will be balanced between all three players. Effects of the Cyberball manipulation (social exclusion/inclusion) will be assessed via ratings in Positive and Negative Affect Scale (PANAS) and Need-Threat-Scale (NTS).
Social exclusion/inclusion induced using Cyberball Game
Time frame: Day 2
experimentally-induced social exclusion stress by using the cyberball paradigm: Subjects will play an online game tossing a ball to each other with two more virtual co-players. Using a cover story, we make subjects believe that the co-players really exist and that they play a live online game. During social exclusion, subjects will be systematically excluded by one co-player (partial exclusion), and during social inclusion, ball tosses will be balanced between all three players. Effects of the Cyberball manipulation (social exclusion/inclusion) will be assessed via ratings in Positive and Negative Affect Scale (PANAS) and Need-Threat-Scale (NTS).
4 secondary outcomes
Concentration of cortisol in saliva
Time frame: Day 1 and Day 2
Positive and Negative Affect Schedule (PANAS)
Time frame: Baseline and after Cyberball Experiment on Day 1 and Day 2
Need Threat Scale (NTS)
Time frame: After Cyberball Experiment on Day 1 and Day 2
Heart rate variability
Time frame: At baseline 5 min AND During experimental part (social inclusion or exclusion) 5 min Day 1 and Day 2
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 28 Aug 2024.
- Background: PubMed 32102102Roayaee M, Rahman RA, Danziger M, Tudge L, Daedelow LS, Heinz A, Wustenberg T. [The others and I: How social interactions change the perception of other persons. The Cyberball paradigm and its indications in the migration context]. Fortschr Neurol Psychiatr. 2020 Feb;88(2):109-117. doi: 10.1055/a-1033-7304. Epub 2020 Feb 26. German.
- Background: PubMed 21110407Staebler K, Helbing E, Rosenbach C, Renneberg B. Rejection sensitivity and borderline personality disorder. Clin Psychol Psychother. 2011 Jul-Aug;18(4):275-83. doi: 10.1002/cpp.705. Epub 2010 May 25.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PIT paradigm, social exclusion (Cyberball task) and Saliva samples in people with Alcohol Use Disorder and Alcoholism, run by Charite University, Berlin, Germany 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 7 inclusion and 6 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: opening soon, as of the sponsor's last update on 28 Aug 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 full-lever specific and general PIT (parallel version) effect day one (time frame: Day 1). The study lists 4 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 NCT06256952, which also lists 2 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 28 Aug 2024.