Stress Clinical Trial
— ReCoDeOfficial title:
Cue Effects in Human Addiction: Pavlovian to Instrumental Transfer
Individuals with substance use disorders (SUD) have to cope with drug-related cues and contexts, which can affect instrumental drug seeking as shown with Pavlovian to instrumental transfer (PIT) paradigms in animals and humans. The investigators aimed to investigate the impact of acute and chronic stress on Pavlovian-to-instrumental transfer (PIT), how PIT it is associated with cognitive control abilities and whether such effects predict losing vs. regaining control in subjects with AUD. Moreover, the investigators aimed to develop a novel full transfer task that assesses both, general and specific PIT to investigate whether specific PIT differs between alcohol use disorder (AUD) and control subjects.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 16 Years to 65 Years |
Eligibility | Inclusion Criteria: - males and females between 16-65 years of age - AUD subjects only: meet a minimum of 2 criteria for DSM-5 alcohol-related disorder (AUD) (not requiring withdrawal as assessed by an independent psychiatrist) and AUDIT > 4 - Smokers: Daily smokers only: smoke 7 days/week during the last three months - Non-daily smokers only: smoke at least once but less than 7 days/week during the last three months - Ability to consent to the study and complete the questionnaires - Sufficient language skills: German - Availability between 3pm-6pm on 2 consecutive days (Experiment 1, acute stress question) - Females only: luteal phase (Experiment 1, acute stress question) Exclusion Criteria: - Lifetime diagnosis according to DMS-5 for: Bipolar disorder, schizophrenia, schizophrenia spectrum disorder, substance dependence except for alcohol, nicotine, or cannabis - Currently meeting DSM-5 diagnostic criteria for a depressive episode, suicidal ideation - Past 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) - MR contraindications (e.g., pacemakers, metallic or electronic implants, metallic splinters, surgical staples) - Color vision deficiency - Sensorineural hearing loss of 30 dB or greater, - Tinnitus - Presence of claustrophobia - Acute alcohol intoxication at MRI appointments verified by breath alcohol testing or drug intoxication verified by rapid urine testing - For women only: not peri- or postmenopausal, not taking contraceptives (Experiment 1, acute stress question) |
Country | Name | City | State |
---|---|---|---|
Germany | Charite - Universitätsmedizin Berlin | Berlin | |
Germany | Technische Universität Dresden | Dresden |
Lead Sponsor | Collaborator |
---|---|
Charite University, Berlin, Germany | Technische Universität Dresden |
Germany,
Belanger MJ, Chen H, Hentschel A, Garbusow M, Ebrahimi C, Knorr FG, Zech HG, Pilhatsch M, Heinz A, Smolka MN. Development of Novel Tasks to Assess Outcome-Specific and General Pavlovian-to-Instrumental Transfer in Humans. Neuropsychobiology. 2022;81(5):37 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neural PIT effect day 1 | blood oxygenation level dependent (BOLD) response, investigation of neuronal activation of the mesolimbic system in AUD patients and controls using 3 Tesla magnetic resonance imaging following Stress or Placebo intervention OR no intervention | Day 1 | |
Primary | Neural PIT effect day 2 | a subsample of subjects has a second assessment with blood oxygenation level dependent (BOLD) response, investigation of neuronal activation of the mesolimbic system in AUD patients and controls using 3 Tesla magnetic resonance imaging following Stress or Placebo intervention | Day 2 | |
Primary | Behavioral PIT effect on performance day 1 | strength of PIT effect assessed with the PIT paradigm. Performance (correct choices) will be recorded. Stronger PIT effects are associated with higher performance (percent correct choices) in congruent versus lower performance in incongruent trials. | Day 1 | |
Primary | Behavioral PIT effect on velocity day 1 | strength of PIT effect assessed with the PIT paradigm. Velocity will be recorded. Stronger PIT effects are associated with higher velocity in conditions with positively valued background stimuli and lower velocity with negatively valued background stimuli. | Day 1 | |
Primary | Behavioral PIT effect on velocity day 2 | a subsample of subjects has a second assessment with the PIT paradigm (parallel version) following Stress or Placebo intervention. At this second day the investigators calculate velocity PIT effect only. | Day 2 | |
Primary | Chronic stress effects on hair cortisol in picogram/milligram | chronic stress assessment via:
- hair cortisol measurement (3 cm hair segments) |
retrospective assessment before PIT testing at Day 1 | |
Primary | Chronic stress quenstionnaire 1 | chronic stress assessment via:
- Trier Inventory for the Assessment of Chronic Stress (TICS; assessing chronic stress over the last three months, likert scale 0-4, with zero meaning never and four meaning very often; high values stand for more stress)) |
retrospective assessment before PIT testing at Day 1 | |
Primary | Chronic stress quenstionnaire 2 | chronic stress assessment via:
- Social Readjustment Rating Scale (SRRS; assessing chronic stress life events of the last year, scaling asking for yes or no. higher values represent more stressful live events over the last year) |
retrospective assessment before PIT testing at Day 1 | |
Primary | Chronic stress quenstionnaire 3 | chronic stress assessment via:
- Perceived Stress Scale (PSS; assessing chronic stress over the last month, likert scale 0-4, with zero meaning never and four meaning very often; high values stand for higher perceived stress) |
retrospective assessment before PIT testing at Day 1 | |
Primary | cognitive control Stroop effect | Cognitive control assessment via:
- Counting Stroop task |
Day 1 | |
Primary | cognitive control Simon effect | Cognitive control assessment via:
No-go Simon task |
Day 1 | |
Primary | cognitive control interference effect | Cognitive control assessment via:
Stop Signal reaction time task |
Day 1 | |
Primary | Acute stress day 1 | Acute stress inducting using:
Trier social stress test (TSST) OR placebo (randomized across days between subjects) |
Day 1 | |
Primary | Acute stress day 2 | Acute stress inducting using:
Trier social stress test (TSST) OR placebo (randomized across days between subjects) |
Day 2 | |
Secondary | Saliva cortisol concentration in nmol/litre | Acute stress effects in AUD and HC | Assessment before, during and after TSST (-60 minutes, 0 minutes, +10 minutes, +20 minutes, +30 minutes,+ 50 minutes, +80 minutes) | |
Secondary | alcohol consumption after 12 months | alcohol drinking amount (quantity, frequency) during a follow-up period of 12 months | 12 months after testing for behavioral and neural PIT effects |
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