Role of Pavlovian Mechanisms for Control Over Substance Use

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorTechnische Universität Dresden

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial population

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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • fMRI imaging (BOLD)

    Biological/Vaccine

    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.

  • sMRI (structure)

    Biological/Vaccine

    Will be used to investigate neural correlates of PIT effects by identifying abnormalities in cortical gray and white matter volume.

  • Pavlovian-to-instrumental transfer (PIT) paradigm

    Behavioral

    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.

  • Basic psychological assessment (interview)

    Diagnostic test

    * 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

  • Basic psychological assessment (questionnaires)

    Diagnostic test

    * 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)

  • Neuropsychological tests

    Behavioral

    * Digit-Symbol-Test (DST) * Digit Span Task * Value-based decision-making task (VBDM)

Treatment groups

200 Participants
are divided into 4 treatment groups
Group A: Alcohol use disorder (AUD)6 interventions
Group B: Alcohol use disorder (AUD) and Substance use disorder (SUD)6 interventions
Group C: Non-AUD Substance use disorder (SUD)6 interventions
Group D: Control group6 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
1 day
2

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.

Time frame
1 day

Secondary outcomes

1

Alcohol and Substance (cannabis, stimulant/cocaine) consumption after 3 months

Alcohol drinking amount and substance (cannabis, amphetamine, cocaine) consuming amount (quantity, frequency) during a follow-up period of 3 months

Time frame
3 months after testing for behavioral and neural PIT effects

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Technische Universität Dresden

Lead sponsor

Charite University, Berlin, Germany

Collaborator

Central Institute of Mental Health, Mannheim

Collaborator