Learning and Relapse Risk in Alcohol Dependence (LeAD)
The aim of this project is to assess which behavioral and neuroimaging alterations associated with reward- based learning predict relapse in alcohol- dependent patients within a follow- up period of 12 months.
The investigators will explore how these alterations interact with clinical and psychosocial factors which can modify the relapse risk. Functional magnetic resonance imaging (fMRI) and positron emission tomography (PET) will be used to identify neurofunctional abnormalities in neurotransmitter systems. The investigators will also provide data for genetic analysis and modeling.
Patients will be detoxified in an inpatient setting and followed for 12 months using the Time-Line Follow- Back Procedure. Clinical assessments, behavioral paradigms of learning and brain imaging will be carried out within at least 4 half- lives after any psychotropic medication.
The investigators will implement and apply functional imaging paradigms assessing Pavlovian-to-instrumental transfer and reversal learning tasks and associate model parameters of learning with alcohol craving, intake and prospective relapse risk.
Alcohol Use Disorders
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Target Follow-Up Duration:||1 Year|
|Official Title:||Learning Mechanisms as Predictors of Treatment Outcome in Alcohol- Dependent Patients|
- blood oxygenation level dependent (BOLD) response [ Time Frame: first assessment time point (alc. dependent pat. up to 21 days after detoxification) ] [ Designated as safety issue: Yes ]investigation of neuronal activation of the mesolimbic system in alcohol-dependent patients and healthy controls using 3 Tesla magnetic resonance imaging
- Treatment response [ Time Frame: 12-month follow-up period beginning after first assessment timepoint ] [ Designated as safety issue: No ]test the predictive effects of learning parameters and related neuronal correlates for treatment outcome (relapse vs abstinence) in alcohol-dependent patients
Biospecimen Retention: Samples With DNA
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Alcohol- dependent patients
Detoxified alcohol- dependent patients in an inpatient setting
Age- and gender matched healthy controls
This project will examine 150 detoxified alcohol-dependent patients and 100 age- and gender matched controls. The main aim of this project is to assess 1) which behavioural and neuroimaging alterations (fMRI) associated with reward-based learning (see Projects 1 & 3) predict relapse within the follow-up period of 6 months, 2) how these interact with clinical and psychosocial factors which can modify the relapse risk, and 3) to provide data for genetic and imaging analyses and modelling. Furthermore, we will explore gender effects on functional imaging parameters of learning. Patients will be detoxified in an inpatient setting and followed for 6 months using the Form 90 and Time-Line Follow-Back Procedure. Clinical assessments, behavioral paradigms of learning, and brain imaging will be carried out within at least 4 half-lives after any psychotropic medication. Subjects will undergo medical management with bimonthly follow-ups and predefined in- and exclusion criteria as described previously. We will implement and apply functional imaging paradigms assessing Pavlovian-to-instrumental transfer and reversal learning as described in Projects 1 and 3. We will associate model parameters of learning with alcohol craving, intake and prospective relapse risk. Independent of these central questions, we will also assess comorbidity, psychosocial and neurobiological disease severity markers to control for specificity of findings.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01679145
|Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden|
|Dresden, Saxony, Germany, 01307|
|Technische Universität Dresden|
|Dresden, Saxony, Germany, 01187|
|Charité - Universitätsmedizin Berlin|
|Berlin, Germany, 10117|
|Principal Investigator:||Andreas Heinz, Prof MD||Charite University, Berlin, Germany|
|Principal Investigator:||Ulrich S Zimmermann, MD||University Hospital Carl Gustav Carus, Dresden, Germany|
|Study Chair:||Andreas Heinz, Prof MD||Charité University, Berlin, Germany|
|Study Director:||Hans-Ulrich Wittchen, Prof PhD||Technische Universität Dresden, Dresden, Germany|