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

NCT06256952 | Not Yet Recruiting

• 1 other identifier: 40217046122
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Alcohol Use Disorder; Alcoholism; Stress Reaction; Ostracism; Substance Use Disorders

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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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).

  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).

  Day 2

Secondary Outcomes (4)

• Concentration of cortisol in saliva

  Day 1 and Day 2

• Positive and Negative Affect Schedule (PANAS)

  Baseline and after Cyberball Experiment on Day 1 and Day 2

• Need Threat Scale (NTS)

  After Cyberball Experiment on Day 1 and Day 2

• Heart rate variability

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

Study Arms (4)

Control (HC) - exclusion first

EXPERIMENTAL

Healthy participants without SUD Cyberball: Exclusion Day 1; Cyberball: Inclusion Day 2

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

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

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

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)

Interventions

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.

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) 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.

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 samples DIAGNOSTIC_TEST

Assessing acute stress effects in AUD and HC subjects

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 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)

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 task DIAGNOSTIC_TEST

Positive and Negative Affect Schedule(PANAS)

Control (HC) - exclusion first; Control (HC) - inclusion first; Moderate to sever alcohol users (AUD) - exclusion first; Moderate to sever alcohol users (AUD) - inclusion first

VAS DIAGNOSTIC_TEST

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

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 DIAGNOSTIC_TEST

* Need Threat Scale * Manipulation check (VAS scale)

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) 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.

Control (HC) - exclusion first; Control (HC) - inclusion first; Moderate to sever alcohol users (AUD) - exclusion first; Moderate to sever alcohol users (AUD) - inclusion first

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Heidelberg University: collaborator
• Zentralinstitut für Seelische Gesundheit Mannheim: collaborator
• Technische Universität Dresden: collaborator

Study Sites (1)

Charite - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Related Publications (2)

• 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.

  PMID: 32102102 BACKGROUND

• Staebler 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.

  PMID: 21110407 BACKGROUND

MeSH Terms

Conditions

Alcoholism; Fractures, Stress; Ostracism; Substance-Related Disorders; Social Isolation

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Fractures, Bone; Wounds and Injuries; Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof., MD, PhD

Model Details: 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.

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: February 13, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

DE (1)