Development of Novel Tasks to Assess Outcome-Specific and General Pavlovian-to-Instrumental Transfer in Humans.
Matthew J Belanger, Hao Chen, Angela Hentschel...
https://pubmed.ncbi.nlm.nih.gov/36380640Actively Recruiting
Age: 16Years - 65Years
All Genders
ID05992272
Cue Effects in Human Addiction: Pavlovian to Instrumental Transfer
Led by Charite University, Berlin, Germany · Updated on 2024-08-21
300
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Charite University, Berlin, Germany
Lead Sponsor
T
Technische Universität Dresden
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how cues related to drugs influence behavior in people with substance use disorders, particularly focusing on alcohol use disorder (AUD) and smoking. The study aims to understand how acute and chronic stress impact Pavlovian-to-instrumental transfer (PIT), a process where conditioned cues affect instrumental actions, and how cognitive control relates to these effects. Researchers also want to compare these effects between AUD subjects and healthy controls, and develop a new task to assess general and specific PIT effects using monetary, alcohol, and food rewards. Participants will be involved in three experiments. The first uses a PIT task with monetary and alcohol cues, combined with acute stress induction via the Trier Social Stress Test and chronic stress assessments through questionnaires and hair cortisol. The second experiment investigates interference effects and cognitive control using tasks like Counting Stroop, No-go Simon, and Stop Signal tasks during fMRI, comparing AUD and non-AUD groups with varying smoking habits. The third experiment applies a new full PIT paradigm with trial-by-trial alcohol and soft drink rewards to explore specific and general PIT effects and their relation to stress and drinking behavior. During the study, participants will complete behavioral tasks, cognitive tests, and neuroimaging scans (fMRI and structural MRI). Stress levels will be monitored through saliva and hair samples, along with questionnaires. Additional data like blood samples for genetic testing and ecological momentary assessments via smartphones will be collected. The main outcomes include neural and behavioral PIT effects, cognitive control measures, and stress markers. Follow-up assessments will examine alcohol consumption over 12 months, with study visits scheduled primarily in the afternoon over two consecutive days.
CONDITIONS
Brief Title
Cue Effects in Human Addiction: Pavlovian to Instrumental Transfer
Who Can Participate
Age: 16Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Males and females between 16 and 65 years of age
- AUD subjects must meet at least 2 DSM-5 criteria for alcohol use disorder and have an AUDIT score greater than 4
- Daily smokers must smoke every day during the last three months
- Non-daily smokers must smoke at least once but less than daily during the last three months
- Ability to give consent and complete questionnaires
- Sufficient German language skills
- Availability between 3 pm and 6 pm on two consecutive days
- Females must be in the luteal phase during Experiment 1
You will not qualify if you...
- Lifetime diagnosis of bipolar disorder, schizophrenia, or substance dependence except alcohol, nicotine, or cannabis
- Current depressive episode or suicidal thoughts
- Past traumatic brain injury or severe neurological disease
- Pregnancy or breastfeeding
- Use of medications affecting the central nervous system within 10 days prior or less than 4 half-lives before participation
- MRI contraindications such as pacemakers or metallic implants
- Color vision deficiency
- Sensorineural hearing loss of 30 dB or more
- Tinnitus
- Claustrophobia
- Acute alcohol or drug intoxication at MRI visits
- Women who are not peri- or postmenopausal or who are taking contraceptives during Experiment 1 acute stress testing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 2 days
Participants undergo diagnostic tests including clinical interviews, questionnaires for chronic stress, blood, saliva, and hair sample collection, as well as baseline assessments of stress and cognitive control.
2 consecutive afternoon visits (approximately 3 pm to 6 pm)
Behavioral and Neuroimaging Assessments
Duration - 2 days
Participants complete multiple behavioral tasks including the Pavlovian to Instrumental Transfer (PIT) paradigm, Counting Stroop task, No-go Simon task, and Stop Signal Task while undergoing fMRI and structural MRI to assess neural correlates of addiction and stress effects.
2 in-person visits on consecutive days
Stress Induction and Monitoring
Duration - Concurrent with Behavioral and Neuroimaging Assessments over 2 days
Acute stress is induced using the Trier Social Stress Test during the assessments, with saliva cortisol measured before, during, and after the stress test to evaluate stress effects on behavior and brain activity.
Included in 2 consecutive in-person visits
Long-term Monitoring
Duration - Up to 12 months after initial testing
Participants are monitored for alcohol consumption and related behaviors through 6 and 12-month follow-up assessments to evaluate the predictive value of stress and PIT effects on alcohol use outcomes.
Follow-up assessments at 6 and 12 months (visit format varies)
Trial Site Locations
Total: 2 locations
1
Charite - Universitätsmedizin Berlin
Berlin, Germany, 10117
Actively Recruiting
2
Technische Universität Dresden
Dresden, Germany, 01307
Actively Recruiting
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Research Team
A
Andreas Heinz, Prof., MD, PhD
M
Maximilian Pilhatsch, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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