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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01679145
Other study ID # HE2597/141;ZI1119/31;WI709/101
Secondary ID
Status Completed
Phase N/A
First received August 31, 2012
Last updated July 27, 2016
Start date January 2012
Est. completion date March 2016

Study information

Verified date July 2016
Source Technische Universität Dresden
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 225
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Charité - Universitätsmedizin Berlin Berlin
Germany Technische Universität Dresden Dresden Saxony
Germany Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden Dresden Saxony

Sponsors (3)

Lead Sponsor Collaborator
Technische Universität Dresden Charite University, Berlin, Germany, University Hospital Carl Gustav Carus

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary blood oxygenation level dependent (BOLD) response investigation of neuronal activation of the mesolimbic system in alcohol-dependent patients and healthy controls using 3 Tesla magnetic resonance imaging first assessment time point (alc. dependent pat. up to 21 days after detoxification) Yes
Secondary Treatment response test the predictive effects of learning parameters and related neuronal correlates for treatment outcome (relapse vs abstinence) in alcohol-dependent patients 12-month follow-up period beginning after first assessment timepoint No
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