- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01679145
Learning and Relapse Risk in Alcohol Dependence (LeAD)
Learning Mechanisms as Predictors of Treatment Outcome in Alcohol- Dependent Patients
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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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-
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Berlin, Tyskland, 10117
- Charité - Universitätsmedizin Berlin
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Saxony
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Dresden, Saxony, Tyskland, 01307
- Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden
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Dresden, Saxony, Tyskland, 01187
- Technische Universität Dresden
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Alcohol dependence according to DSM-IV
- Minimum of 72 hours of abstinence, maximum of 21 days of abstinence
- Minimum of three years of alcohol dependence
- Low severity of withdrawal symptoms
- Ability to provide fully informed consent and to use self- rating scales
Exclusion Criteria:
- Lifetime history of DSM- IV bipolar or psychotic disorder
- Current threshold DSM-IV diagnosis of any following disorders: current major - depressive disorder, generalized anxiety disorder, PTSD, borderline personality disorder or obsessive- compulsive disorder
- History of substance dependence other than alcohol or nicotine dependence
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
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Alcohol- dependent patients
Detoxified alcohol- dependent patients in an inpatient setting
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Control group
Age- and gender matched healthy controls
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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blood oxygenation level dependent (BOLD) response
Tidsramme: 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
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first assessment time point (alc. dependent pat. up to 21 days after detoxification)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Treatment response
Tidsramme: 12-month follow-up period beginning after first assessment timepoint
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test the predictive effects of learning parameters and related neuronal correlates for treatment outcome (relapse vs abstinence) in alcohol-dependent patients
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12-month follow-up period beginning after first assessment timepoint
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Ulrich S Zimmermann, MD, University Hospital Carl Gustav Carus, Dresden, Germany
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Sebold M, Spitta G, Gleich T, Dembler-Stamm T, Butler O, Zacharias K, Aydin S, Garbusow M, Rapp M, Schubert F, Buchert R, Gallinat J, Heinz A. Stressful life events are associated with striatal dopamine receptor availability in alcohol dependence. J Neural Transm (Vienna). 2019 Sep;126(9):1127-1134. doi: 10.1007/s00702-019-01985-2. Epub 2019 Feb 12.
- Schad DJ, Garbusow M, Friedel E, Sommer C, Sebold M, Hagele C, Bernhardt N, Nebe S, Kuitunen-Paul S, Liu S, Eichmann U, Beck A, Wittchen HU, Walter H, Sterzer P, Zimmermann US, Smolka MN, Schlagenhauf F, Huys QJM, Heinz A, Rapp MA. Neural correlates of instrumental responding in the context of alcohol-related cues index disorder severity and relapse risk. Eur Arch Psychiatry Clin Neurosci. 2019 Apr;269(3):295-308. doi: 10.1007/s00406-017-0860-4. Epub 2018 Jan 8.
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HE2597/141;ZI1119/31;WI709/101
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