Learning and Relapse Risk in Alcohol Dependence (LeAD)
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|ClinicalTrials.gov Identifier: NCT01679145|
Recruitment Status : Completed
First Posted : September 5, 2012
Last Update Posted : July 28, 2016
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.
|Condition or disease|
|Alcohol Use Disorders|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||225 participants|
|Observational Model:||Case Control|
|Target Follow-Up Duration:||1 Year|
|Official Title:||Learning Mechanisms as Predictors of Treatment Outcome in Alcohol- Dependent Patients|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
Alcohol- dependent patients
Detoxified alcohol- dependent patients in an inpatient setting
Age- and gender matched healthy controls
- blood oxygenation level dependent (BOLD) response [ Time Frame: first assessment time point (alc. dependent pat. up to 21 days after detoxification) ]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 ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679145
|Technische Universität Dresden|
|Dresden, Saxony, Germany, 01187|
|Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden|
|Dresden, Saxony, Germany, 01307|
|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|