Clinical trial NCT06256952: Effect of Social Isolation on the Role of Pavlovian Mechanisms for Control Over Alcohol Use
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Heidelberg University
name: Zentralinstitut für Seelische Gesundheit Mannheim
name: Technische Universität Dresden
First posted: 2024-02-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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 outcomes:
measure: Behavioral full-lever specific and general PIT (parallel version) effect day one
timeFrame: Day 1
measure: Behavioral full-lever specific and general PIT (parallel version) effect day two
timeFrame: Day 2
measure: Social exclusion/inclusion induced using Cyberball Game
timeFrame: Day 1
measure: Social exclusion/inclusion induced using Cyberball Game
timeFrame: Day 2
Secondary outcomes:
measure: Concentration of cortisol in saliva
timeFrame: Day 1 and Day 2
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Baseline and after Cyberball Experiment on Day 1 and Day 2
measure: Need Threat Scale (NTS)
timeFrame: After Cyberball Experiment on Day 1 and Day 2
measure: Heart rate variability
timeFrame: At baseline 5 min AND During experimental part (social inclusion or exclusion) 5 min Day 1 and Day 2
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite - Universitätsmedizin Berlin
Study officials:
References:
citation: 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.
citation: 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.