Role of Pavlovian Mechanisms for Control Over Substance Use
ReCoDe
SFB TRR 265: Losing and Regaining Control Over Drug Intake Work Package 1 of Project B03: General and Specific Pavlovian-to-Instrumental Transfer Effects in a Range of Substance Use Disorders
1 other identifier
observational
200
1 country
1
Brief Summary
During the first funding period (1st FP), the investigators developed a novel full Pavlovian-to-instrumental transfer (PIT) task that allows assessing both, general and specific PIT to investigate whether specific PIT differs between alcohol use disorder (AUD) and control subjects. Preliminary analyses of the full transfer task indicate that AUD participants exhibit a stronger specific PIT effect compared to controls. Based on these findings, the investigators want to compare specific and general PIT effects in patients with moderate to severe substance use disorders (alcohol, cannabis, methamphetamine, amphetamine and cocaine) to healthy controls on the behavioral and neural level (fMRI).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2024
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 5, 2024
CompletedFirst Submitted
Initial submission to the registry
September 25, 2024
CompletedFirst Posted
Study publicly available on registry
November 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
November 22, 2024
September 1, 2024
2.9 years
September 25, 2024
November 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Neural PIT effect
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
1 day
Behavioral full-lever specific and general PIT effect
Strength of specific and general PIT effect assessed with the full-lever PIT paradigm. Specific: average percentage of alcohol choice difference during the presentation of alcohol or non-alcohol Pavlovian background. General: differences in number of button presses during the presentation of positive (+10 Euro) and negative (-10 Euro) Pavlovian backgrounds.
1 day
Secondary Outcomes (1)
Alcohol and Substance (cannabis, stimulant/cocaine) consumption after 3 months
3 months after testing for behavioral and neural PIT effects
Study Arms (4)
Alcohol use disorder (AUD)
Participants with alcohol use disorder (moderate to severe if no withdrawal symptoms) and no other substance use disorder (SUD)
Alcohol use disorder (AUD) and Substance use disorder (SUD)
Participants with Alcohol use disorder (AUD) and comorbid Substance use disorder (SUD) (moderate to severe cases without withdrawal symptoms) including: Participants with alcohol use disorder (AUD) and/or cannabis use disorder and/or methamphetamine use disorder and/or amphetamine use disorder and/or cocaine use disorder.
Non-AUD Substance use disorder (SUD)
Participants with substance use disorder (moderate to severe cases without withdrawal symptoms) without alcohol use disorder (AUD) including: Participants with methamphetamine use disorder and/or cannabis use disorder and/or amphetamine use disorder and/or cocaine use disorder
Control group
Healthy participants without AUD or SUD
Interventions
Will be used to investigate neural correlates of Pavlovian-to-instrumental transfer (PIT) effects by measuring the blood oxygenation level dependent (BOLD) response of neural activation in the mesolimbic system.
Will be used to investigate neural correlates of PIT effects by identifying abnormalities in cortical gray and white matter volume.
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.
* Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) * Quantity Frequency: Alcohol, Cannabis, (Meth-) Amphetamine, Cocaine) * SCID: AUD and SUD (Cannabis, Methamphetamine, Amphetamine, Cocaine) criteria and last year \& depressive symptoms \& symptoms for Mania and psychotic disorder (acute and lifetime) MiniDIPS psychotic disorders
* Sociodemographics * 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 and STAI-S) * Adult ADHD Self-Report Scale (ASRS) * Alcohol Use Disorders Identification Test (AUDIT) * CAS -A (Alkohol) * Cannabis Use Disorders Identification Test (CUDIT) * Fragebogen zu Gedanken und Gefühle 14 Items (FGG-14) * Fragebogen zur Sozialen Unterstützung (F-SozU-K14) * Trierer Inventar zum chronischen Stress (TICS) * Oslo 3-Items-Social-Support Scale (Oslo-3) * Social Readjustment Rating Scale (SRRS) * International Trauma Questionnaire (ITQ) * Positive and Negative Affect Schedule (PANAS)
* Digit-Symbol-Test (DST) * Digit Span Task * Value-based decision-making task (VBDM)
Eligibility Criteria
Groups will be recruited through the addiction in- and outpatient clinic of the Charité, and from the special outpatient clinic for MUD at the University Hospital Dresden as well as from our strategic partner clinic in Radebeul and Städtisches Klinikum Dresden. Moreover, collaborating clinics in Berlin and Dresden will be recruited (with in- or outpatient clinics for treating patients with substance use disorder). Finally, we recruit persons from information centers for substance related problems and addiction groups in Berlin and Dresden and from the general population using advertisement.
You may qualify if:
- Men and women between 18-65 years of age,
- AUD, and/or SUD subjects only: meet 4 or more criteria for DSM-5 alcohol-related and/or substance-related (cannabis, amphetamine, methamphetamine or cocaine 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(German) and motor skills for using PC
- existing health insurance
You may not qualify if:
- Lifetime diagnosis of DSM-5 bipolar disorder or schizophrenia or schizophrenia spectrum disorder (if induced by drugs, it should happen more than a month ago)
- Current threshold DSM-5 diagnosis of major depressive disorder, or presence of suicidal intention
- High risk (≤ 26) ASSIST scores in other substances other than alcohol, amphetamine, methamphetamine, cannabis, cocaine, tobacco
- History of traumatic brain injury or severe neurological disease (such as Dementia, Parkinson's disease, multiple sclerosis, Epilepsy, Meningitis, Stroke)
- Pregnancy or breastfeeding,
- Ingestion of medications known to interact with the dopamine system in the 10-day period prior to study participation or less than 4 half-lives after last ingestion (rapid urine test); A detailed list of permitted medication can be added upon request
- 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 and
- Acute alcohol, substance (cannabis, or methamphetamine, amphetamine, cocaine) intoxication at assessement day verified by breath alcohol tests and drug intoxication verified by rapid urine test.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Technische Universität Dresdenlead
- Charite University, Berlin, Germanycollaborator
- Central Institute of Mental Health, Mannheimcollaborator
Study Sites (1)
Department of Psychiatry and Psychotherapy, Technische Universität Dresden
Dresden, Germany
Related Publications (1)
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):370-386. doi: 10.1159/000526774. Epub 2022 Nov 14.
PMID: 36380640BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2024
First Posted
November 22, 2024
Study Start
August 5, 2024
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
November 22, 2024
Record last verified: 2024-09