Alcohol Use Disorder (AUD)ReCoDeNCT06701487
Role of Pavlovian Mechanisms for Control Over Substance Use
An observational study of Alcohol Use Disorder (AUD) and Alcoholism, run by Technische Universität Dresden at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Use Disorder (AUD), Alcoholism, Substance Use Disorders
- What is being tested?
- fMRI imaging (BOLD), sMRI (structure) and Pavlovian-to-instrumental transfer (PIT) paradigm
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 5 Aug 2024to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Psychiatry and Psychotherapy, Technische Universität Dresden
Dresden
Maximilian Pilhatsch, Prof. Dr., 0049 35 146 342 211, maximilian.pilhatsch@tu-dresden.de
Michael Smolka, Prof. Dr.
About this study
Official title: 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
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).
Read the detailed description
This projects research aim:
- The investigators aim to compare general and specific PIT effects in patients with moderate to severe substance use disorder (Alcohol, Methamphetamine, Amphetamine and Cocaine) and healthy controls using the newly developed (1st FP) full transfer task and fMRI The investigators expect enhanced general PIT effects in patients compared to controls at the behavioral level, and at the neuronal level enhanced PIT-associated activations in the striatum, and lower activation in the prefrontal cortex (e.g., dlPFC).
The investigators expect enhanced general PIT effects in patients with multiple SUD compared to patients with single SUD.
The investigators expect increased behavioral and neuronal alcohol-specific PIT effects in patients groups that also meet AUD criteria compared to controls and to patients without AUD.
The investigators expect stronger behavioral and neural PIT effects (both general and specific) to predict more substance use at 3-month follow-up.
Therefore, the investigators aim to conduct the Experiments with the following Hypotheses:
Here the investigators assess on a behavioral and neural level a general and specific PIT task by using the full transfer task which was developed in the 1st FP and allows the assessment of both PIT tasks in one paradigm. This task consists of 4 parts: instrumental training, Pavlovian conditioning, Pavlovian-to-instrumental transfer phase and query trials to test participants' explicit knowledge.
The investigators will investigate HCs and three patient groups of high clinical relevance: Patients with (1) AUD without comorbid SUD (cannabis, methamphetamine, amphetamine or cocaine), (2) AUD with comorbid SUD (cannabis and/or methamphetamine and/or amphetamine and/or cocaine), (3) SUD (cannabis and/or methamphetamine and/or amphetamine and/or cocaine) without AUD. The investigators will recruit patients through the addiction outpatient clinic of the Charité (mainly cannabis), the special outpatient clinic for MUD at the University Hospital Dresden as well as the investigators' strategic partner clinic in Radebeul und Städtisches Klinikum Dresden. Furthermore, the investigators will be recruiting from the general population using advertisement. On site, they undergo the comprehensive assessment implemented for the TRR cohort during the 1st FP. The full PIT paradigm is applied as described in Figure 3. Three months after the examination, an online follow-up on the clinical course will be done by using redcap-based questionnaires.
Methods:
WP1 will follow an ANOVA with four groups, including post-hoc group differences.
Functional imaging data will be conducted using a 3 T MR scanner to acquire gradient echo t2*-weighted echo-planar images (EPI) and analyzed with SPM12. EPI images will be preprocessed and analyzed as implemented during the 1st FP.
Expected results:
The investigators expect that general PIT effects are increased in all patient groups vs. HCs. Moreover, the investigators expect that patients with AUD + comorbid SUD have greater general PIT effects than patients with AUD alone. Concerning alcohol specific PIT, the investigators expect that both AUD groups, but not patients with SUD without AUD have greater effects than HCs. Moreover, the investigators expect that patients with AUD + comorbid SUD have greater alcohol specific PIT effects than patients with AUD alone. Concerning neuroimaging, the investigators expect greater activations in striatum and reduced activation in the DLPFC during PIT in all patient groups vs. HCs. Moreover, the investigators expect greater activations in striatum and reduced activation in the DLPFC in patients with AUD + comorbid SUD as well as in patients with AUD alone. Of note, the investigators expect similar neural activations during specific PIT in HCs and patients with SUD without AUD.
Hypothesis 1a.:
General PIT effects are increased in all patient groups vs. HCs. Specifically, patients with AUD + comorbid SUD will show greater general PIT effects than patients with AUD alone. At the neuronal level patients will show enhanced PIT-associated activations in the striatum, and lower activation in the prefrontal cortex (e.g., dlPFC).
Hypothesis 1b:
Concerning alcohol specific PIT, it is expected that both AUD groups, but not patients with SUD without AUD have greater effects than HC. Moreover, patients with AUD + comorbid SUD will have greater alcohol specific PIT effects than patients with AUD alone. Moreover, the investigators expect greater activations in striatum and reduced activation in the DLPFC in patients with AUD + comorbid SUD as well as in patients with AUD alone.
Hypothesis 1c:
The investigators expect that enhanced specific and general PIT effects are associated with increased substance use at the 3-month follow-up.
Alternative strategies: In case of doubt about the extent to which gustatory alcohol and juice rewards increase the PIT effect in subjects with comorbid SUD, the investigators might alternatively develop and pilot a specific PIT paradigm with substance-related pictures.
- Conditions
- Alcohol Use Disorder (AUD), Alcoholism, Substance Use Disorders, Cannabis Use Disorder, Methamphetamine-dependence, Amphetamine Use Disorder
- Being tested
- fMRI imaging (BOLD), sMRI (structure), Pavlovian-to-instrumental transfer (PIT) paradigm, Basic psychological assessment (interview), Basic psychological assessment (questionnaires)
- Keywords
- Substance Use Disorder (SUD), Cannabise Use Disorder, Methamphetamine Use Disorder, Amphetamine Use Disorder, Cocaine Use Disorder, Alcohol Use Disorder (AUD), Pavlovian-to-Instrumental Transfer (PIT), General Pavlovian-to-Instrumental Transfer, Outcome-specific Pavlovian-to-Instrumental Transfer, Amygdala, Ventral Striatum, Neuroimaging, Humans, Surveys and Questionnaires, Reward, Cues
- Medical subject headings
- Alcoholism, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRI imaging (BOLD)Biological
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
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) paradigmBehavioural
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 testsBehavioural
- Digit-Symbol-Test (DST)
- Digit Span Task
- Value-based decision-making task (VBDM)
| Study group | Role | What they receive |
|---|---|---|
| Alcohol use disorder (AUD) | Participants with alcohol use disorder (moderate to severe if no withdrawal symptoms) and no other substance use disorder (SUD) Receives: Biological: fMRI imaging (BOLD); Biological: sMRI (structure); Behavioral: Pavlovian-to-instrumental transfer (PIT) paradigm; Diagnostic Test: Basic psychological assessment (interview); Diagnostic Test: Basic psychological assessment (questionnaires); Behavioral: Neuropsychological tests | |
| 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. Receives: Biological: fMRI imaging (BOLD); Biological: sMRI (structure); Behavioral: Pavlovian-to-instrumental transfer (PIT) paradigm; Diagnostic Test: Basic psychological assessment (interview); Diagnostic Test: Basic psychological assessment (questionnaires); Behavioral: Neuropsychological tests | |
| 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 Receives: Biological: fMRI imaging (BOLD); Biological: sMRI (structure); Behavioral: Pavlovian-to-instrumental transfer (PIT) paradigm; Diagnostic Test: Basic psychological assessment (interview); Diagnostic Test: Basic psychological assessment (questionnaires); Behavioral: Neuropsychological tests | |
| Control group | Healthy participants without AUD or SUD Receives: Biological: fMRI imaging (BOLD); Biological: sMRI (structure); Behavioral: Pavlovian-to-instrumental transfer (PIT) paradigm; Diagnostic Test: Basic psychological assessment (interview); Diagnostic Test: Basic psychological assessment (questionnaires); Behavioral: Neuropsychological tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 3 months after testing for behavioral and neural PIT effects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start5 Aug 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use Disorder (AUD)Studies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany, Central Institute of Mental Health, Mannheim
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06701487
- Sponsor's protocol ID
- 40217046121
- Acronym
- ReCoDe
- Status last verified
- Sep 2024
- First submitted
- 25 Sep 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36380640
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06701487
- Acronym / sponsor ID
- ReCoDe / 40217046121
- Conditions
- Alcohol Use Disorder (AUD), Alcoholism, Substance Use Disorders, Cannabis Use Disorder, Methamphetamine-dependence, Amphetamine Use Disorder
- Keywords
- Substance Use Disorder (SUD), Cannabise Use Disorder, Methamphetamine Use Disorder, Amphetamine Use Disorder, Cocaine Use Disorder, Alcohol Use Disorder (AUD), Pavlovian-to-Instrumental Transfer (PIT), General Pavlovian-to-Instrumental Transfer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany, Central Institute of Mental Health, Mannheim
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 22 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This projects research aim:
- The investigators aim to compare general and specific PIT effects in patients with moderate to severe substance use disorder (Alcohol, Methamphetamine, Amphetamine and Cocaine) and healthy controls using the newly developed (1st FP) full transfer task and fMRI The investigators expect enhanced general PIT effects in patients compared to controls at the behavioral level, and at the neuronal level enhanced PIT-associated activations in the striatum, and lower activation in the prefrontal cortex (e.g., dlPFC).
The investigators expect enhanced general PIT effects in patients with multiple SUD compared to patients with single SUD.
The investigators expect increased behavioral and neuronal alcohol-specific PIT effects in patients groups that also meet AUD criteria compared to controls and to patients without AUD.
The investigators expect stronger behavioral and neural PIT effects (both general and specific) to predict more substance use at 3-month follow-up.
Therefore, the investigators aim to conduct the Experiments with the following Hypotheses:
Here the investigators assess on a behavioral and neural level a general and specific PIT task by using the full transfer task which was developed in the 1st FP and allows the assessment of both PIT tasks in one paradigm. This task consists of 4 parts: instrumental training, Pavlovian conditioning, Pavlovian-to-instrumental transfer phase and query trials to test participants' explicit knowledge.
The investigators will investigate HCs and three patient groups of high clinical relevance: Patients with (1) AUD without comorbid SUD (cannabis, methamphetamine, amphetamine or cocaine), (2) AUD with comorbid SUD (cannabis and/or methamphetamine and/or amphetamine and/or cocaine), (3) SUD (cannabis and/or methamphetamine and/or amphetamine and/or cocaine) without AUD. The investigators will recruit patients through the addiction outpatient clinic of the Charité (mainly cannabis), the special outpatient clinic for MUD at the University Hospital Dresden as well as the investigators' strategic partner clinic in Radebeul und Städtisches Klinikum Dresden. Furthermore, the investigators will be recruiting from the general population using advertisement. On site, they undergo the comprehensive assessment implemented for the TRR cohort during the 1st FP. The full PIT paradigm is applied as described in Figure 3. Three months after the examination, an online follow-up on the clinical course will be done by using redcap-based questionnaires.
Methods:
WP1 will follow an ANOVA with four groups, including post-hoc group differences.
Functional imaging data will be conducted using a 3 T MR scanner to acquire gradient echo t2*-weighted echo-planar images (EPI) and analyzed with SPM12. EPI images will be preprocessed and analyzed as implemented during the 1st FP.
Expected results:
The investigators expect that general PIT effects are increased in all patient groups vs. HCs. Moreover, the investigators expect that patients with AUD + comorbid SUD have greater general PIT effects than patients with AUD alone. Concerning alcohol specific PIT, the investigators expect that both AUD groups, but not patients with SUD without AUD have greater effects than HCs. Moreover, the investigators expect that patients with AUD + comorbid SUD have greater alcohol specific PIT effects than patients with AUD alone. Concerning neuroimaging, the investigators expect greater activations in striatum and reduced activation in the DLPFC during PIT in all patient groups vs. HCs. Moreover, the investigators expect greater activations in striatum and reduced activation in the DLPFC in patients with AUD + comorbid SUD as well as in patients with AUD alone. Of note, the investigators expect similar neural activations during specific PIT in HCs and patients with SUD without AUD.
Hypothesis 1a.:
General PIT effects are increased in all patient groups vs. HCs. Specifically, patients with AUD + comorbid SUD will show greater general PIT effects than patients with AUD alone. At the neuronal level patients will show enhanced PIT-associated activations in the striatum, and lower activation in the prefrontal cortex (e.g., dlPFC).
Hypothesis 1b:
Concerning alcohol specific PIT, it is expected that both AUD groups, but not patients with SUD without AUD have greater effects than HC. Moreover, patients with AUD + comorbid SUD will have greater alcohol specific PIT effects than patients with AUD alone. Moreover, the investigators expect greater activations in striatum and reduced activation in the DLPFC in patients with AUD + comorbid SUD as well as in patients with AUD alone.
Hypothesis 1c:
The investigators expect that enhanced specific and general PIT effects are associated with increased substance use at the 3-month follow-up.
Alternative strategies: In case of doubt about the extent to which gustatory alcohol and juice rewards increase the PIT effect in subjects with comorbid SUD, the investigators might alternatively develop and pilot a specific PIT paradigm with substance-related pictures.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Alcohol use disorder (AUD) | – | Biological: fMRI imaging (BOLD), Biological: sMRI (structure), Behavioral: Pavlovian-to-instrumental transfer (PIT) paradigm, Diagnostic Test: Basic psychological assessment (interview), Diagnostic Test: Basic psychological assessment (questionnaires), Behavioral: Neuropsychological testsParticipants 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) | – | Biological: fMRI imaging (BOLD), Biological: sMRI (structure), Behavioral: Pavlovian-to-instrumental transfer (PIT) paradigm, Diagnostic Test: Basic psychological assessment (interview), Diagnostic Test: Basic psychological assessment (questionnaires), Behavioral: Neuropsychological testsParticipants 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) | – | Biological: fMRI imaging (BOLD), Biological: sMRI (structure), Behavioral: Pavlovian-to-instrumental transfer (PIT) paradigm, Diagnostic Test: Basic psychological assessment (interview), Diagnostic Test: Basic psychological assessment (questionnaires), Behavioral: Neuropsychological testsParticipants 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 | – | Biological: fMRI imaging (BOLD), Biological: sMRI (structure), Behavioral: Pavlovian-to-instrumental transfer (PIT) paradigm, Diagnostic Test: Basic psychological assessment (interview), Diagnostic Test: Basic psychological assessment (questionnaires), Behavioral: Neuropsychological testsHealthy participants without AUD or SUD |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fMRI imaging (BOLD)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. | Biological | Alcohol use disorder (AUD), Alcohol use disorder (AUD) and Substance use disorder (SUD), Control group, Non-AUD Substance use disorder (SUD) |
| sMRI (structure)Will be used to investigate neural correlates of PIT effects by identifying abnormalities in cortical gray and white matter volume. | Biological | Alcohol use disorder (AUD), Alcohol use disorder (AUD) and Substance use disorder (SUD), Control group, Non-AUD Substance use disorder (SUD) |
| Pavlovian-to-instrumental transfer (PIT) paradigmThe 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. | Behavioural | Alcohol use disorder (AUD), Alcohol use disorder (AUD) and Substance use disorder (SUD), Control group, Non-AUD Substance use disorder (SUD) |
| Basic psychological assessment (interview)* 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 | Diagnostic test | Alcohol use disorder (AUD), Alcohol use disorder (AUD) and Substance use disorder (SUD), Control group, Non-AUD Substance use disorder (SUD) |
| Basic psychological assessment (questionnaires)* 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) | Diagnostic test | Alcohol use disorder (AUD), Alcohol use disorder (AUD) and Substance use disorder (SUD), Control group, Non-AUD Substance use disorder (SUD) |
| Neuropsychological tests* Digit-Symbol-Test (DST) * Digit Span Task * Value-based decision-making task (VBDM) | Behavioural | Alcohol use disorder (AUD), Alcohol use disorder (AUD) and Substance use disorder (SUD), Control group, Non-AUD Substance use disorder (SUD) |
Primary outcome
Neural PIT effect
Time frame: 1 day
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
Behavioral full-lever specific and general PIT effect
Time frame: 1 day
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 secondary outcome
Alcohol and Substance (cannabis, stimulant/cocaine) consumption after 3 months
Time frame: 3 months after testing for behavioral and neural PIT effects
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Background: PubMed 36380640Belanger 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Department of Psychiatry and Psychotherapy, Technische Universität Dresden
Dresden, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Use Disorder (AUD) and Alcoholism, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neural PIT effect (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06701487, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.