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Clinical Trials in Germany / NCT06256952
Starting soon Not applicable

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

NCT06256952 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2024-10-01
Last updated
2024-08-28

Condition(s) studied

Alcohol Use DisorderAlcoholismStress ReactionOstracismSubstance Use Disorders

Investigational drug(s) / intervention(s)

PIT paradigmsocial exclusion (Cyberball task)Saliva samplesbasic psychological assessmentpre and post cyberball taskVASafter cyberball tasksocial inclusion (Cyberball task)

PIT paradigm: 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): 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: Assessing acute stress effects in AUD and HC subjects

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)

pre and post cyberball task: Positive and Negative Affect Schedule(PANAS)

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

after cyberball task: * Need Threat Scale * Manipulation check (VAS scale)

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Charite - Universitätsmedizin Berlin Berlin Germany

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06256952 on ClinicalTrials.gov ↗ ← All trials in Germany