Effect of Social Isolation on the Role of Pavlovian Mechanisms for Control Over Alcohol Use

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCharite University, Berlin, Germany

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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,

Trial design

Design model

Parallel

Treatments tested in this trial

  • PIT paradigm

    Behavioral

    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)

    Behavioral

    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 samples

    Diagnostic test

    Assessing acute stress effects in AUD and HC subjects

  • basic psychological assessment

    Diagnostic 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 task

    Diagnostic test

    Positive and Negative Affect Schedule(PANAS)

  • VAS

    Diagnostic test

    subjective arousal, subjective stress, valence, perceived ostracisms/loneliness

  • after cyberball task

    Diagnostic test

    * Need Threat Scale * Manipulation check (VAS scale)

  • social inclusion (Cyberball task)

    Behavioral

    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.

Treatment groups

100 Participants
are divided into 4 treatment groups
Group A: Control (HC) - exclusion firstExperimental treatment 8 interventions
Group B: Control (HC) - inclusion firstExperimental treatment 8 interventions
Group C: Moderate to sever alcohol users (AUD) - exclusion firstExperimental treatment 8 interventions
Group D: Moderate to sever alcohol users (AUD) - inclusion firstExperimental treatment 8 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 1
2

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.

Time frame
Day 2
3

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).

Time frame
Day 1
4

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).

Time frame
Day 2

Secondary outcomes

1

Concentration of cortisol in saliva

\[Time Frame: Assessment before, during and after Cyberball game (T1: arrival of subject), T2: right before Cyberball game, T3: right after Cyberball game, T4: after PIT part 3 and T5: at the end of testing day)\]

Time frame
Day 1 and Day 2
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

Time frame
Baseline and after Cyberball Experiment on Day 1 and Day 2
3

Need Threat Scale (NTS)

Scale from 1 to 5, high scores indicate high needs in Belonging, Control, Meaningful existence and self-esteem

Time frame
After Cyberball Experiment on Day 1 and Day 2
4

Heart rate variability

Time frame
At baseline 5 min AND During experimental part (social inclusion or exclusion) 5 min Day 1 and Day 2

Other outcomes

Sponsors and contacts

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Charite University, Berlin, Germany

Lead sponsor

Heidelberg University

Collaborator

Zentralinstitut für Seelische Gesundheit Mannheim

Collaborator

Technische Universität Dresden

Collaborator

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