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Stress and social cognition in cocaine users

The effect of psychosocial and craving-induced stress on social cognition and decision-making in cocaine users: a longitudinal approach

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN10690316
Enrollment
130
Registered
2019-06-28
Start date
2016-10-01
Completion date
Unknown
Last updated
2023-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cocaine use disorder Mental and Behavioural Disorders Mental and behavioural disorders due to use of cocaine

Interventions

Eighty regular cocaine users and 50 healthy stimulant-naïve controls will be assessed at screening, baseline and at a 4-month follow-up. Participants are first invited to a screening session for the a
Dziobek et al., 2008), a measure of empathy, and a social and non-social decision-making test battery containing the Social Discounting (Strombach et al., 2015), Delay Discounting (Kirby et al., 1999)
Figner et al., 2009) to measure empathy and decision-making without the influence of stress. After the screening, participants are invited to two further sessions: a baseline and a 4-months follow-up.
Kirschbaum et al., 1993) and the Cocaine Cue Video Test. The TSST is a well-established test in order to provoke psychosocial stress primarily by an unprepared speech and mental arithmetic performed i

Sponsors

Psychiatric Hospital of the University of Zurich
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: General inclusion criteria: 1. To be able to read, understand and provide written informed consent 2. To be fluent in German 3. Women and men between the ages of 18 to 52 years 4. For women at baseline and follow up: not during menstruation phase Specific inclusion criteria for cocaine users: 1. Estimated lifetime cocaine consumption >100 g 2. The abstinence duration from cocaine is <6 months 3. No regular use of opioids 4. No current polytoxic drug use pattern 5. No DSM-IV/5 Axis I adult psychiatric disorders — except for other substance use disorders (with exception of opioids), attention deficit hyperactivity disorder (ADHD), and a past depressive episode Specific inclusion criteria for controls: 1. No DSM-IV/5 Axis I adult psychiatric disorders (except for tobacco use disorder) 2. No illegal drug use: less than 15 occasions and not during the last month (with the exception of cannabis)

Exclusion criteria

Exclusion criteria: 1. Family history of genetic mediated (h2 > 0.5) psychiatric disorders according to DSM-IV/5 2. Presence of severe neurological disorder or brain injury 3. Current diagnoses of infectious diseases or severe somatic disorder 4. History of autoimmune, endocrine or rheumatoid arthritis 5. Intake of medication with potential action at central nervous system during the last three days 6. Participation in the Zurich Cocaine Cognition Study (KEK-Nr. E-14/2009) 7. For women: pregnancy or breastfeeding 8. Subjects can be excluded for matching reasons (age, sex, nicotine status)

Design outcomes

Primary

MeasureTime frame
1. Social decision-making is measured by the Social Discounting Task at screening, baseline, and follow-up; and by the Distribution Game and Dictator Game at baseline and follow-up 2. Decision-making as a function of information use is measured by the Columbia Card Task at screening, baseline, and follow-up 3. Tolerance of delayed gratification is measured by the Delay Discounting task at screening, baseline, and follow-up 4. Empathy is measured by the Multifaceted Empathy Test (MET) at screening, baseline, and follow-up 5. Mental and emotional perspective-taking is measured by the Movie for the Assessment of Social Cognition (MASC) at baseline and follow-up. 6. Cortisol, ACTH, and noradrenaline (i.e., endocrinological stress markers) are measured by 10 blood samples, while cortisol and alpha-amylase are determined in 13 saliva samples at baseline and follow-up 7. Gene expression for 16 stress-related genes of interest (NR3C1, FKBP5, ADRA2A, SLC6A2, CRH, CRHR1, CRHR2, SLC6A3, SLC6A4, FOS, EGR2, EGR1, NFKB1, NFKB2, SP1, IL1B) are measured by 5 blood samples in PAXgene Blood RNA Tubes (PreAnalytiX Cat. No. 762165, BD) at baseline and follow-up 8. Electrophysiological stress markers: heart rate, heart rate variability, and electrodermal activity (EDA) are recorded using a BIOPAC System (Goleta, CA, USA) during the TSST and during the Cocaine Cue Video Test at baseline and follow-up 9. Pupil size in response to the Cocaine Cue Video Test recorded using the Eyelink 1000 remote system (SR Research Ltd, Canada) at baseline and follow-up

Secondary

MeasureTime frame
1. Social network is measured by the Social Network Questionnaire at screening 2. Motivation, tiredness, happiness, craving, stress, angriness, disgust, anxiety are all measured by a Visual Analogue Scale at screening, baseline and follow-up 3. Substance consumption patterns are measured by the Interview for Psychotropic Drug Consumption (IPDC) at screening, baseline and follow-up 4. Recent drug use is measured by substance concentrations in hair (~50 substances and major metabolites) at screening, baseline and follow-up 5. Spatial working memory and visual processing are measured by the Spatial Working Memory, Rapid Visual Information Processing and Matching to Sample Visual Search tasks from the Cambridge Neuropsychological Test Automated Battery (CANTAB) at screening 6. Childhood trauma is measured by the Childhood Trauma Questionnaire at screening 7. Empathy and optimism bias are assessed with an experimental task (“Optimism Bias and Empathy Task”) at screening 8. Psychiatric Symptoms are measured by the Brief Symptoms Inventory (BSI) at screening, baseline, and follow-up 9. Potentially stressful life events are measured by the Holmes-Rahe Stress Inventory at screening, baseline, and follow-up 10. Goal attainment is measured by the Goal Attainment Scale at screening 11. Self-control is measured by the Self-control scale at screening 12. Consumption habit is measured by the Self-Report Habit Index at screening 13. General smartphone activity is assessed by an application that is installed with the participant's consent on their smartphones at screening and uninstalled at follow-up 14. Craving is measured by the Cocaine Craving Questionnaire at baseline and follow-up 15. Quality of life is measured by the Global Health Questionnaire at baseline

Countries

Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026