Learning and Relapse Risk in Alcohol Dependence (LeAD)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Charite University, Berlin, Germany
University Hospital Carl Gustav Carus
Information provided by (Responsible Party):
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT01679145
First received: August 31, 2012
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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

liver encymes


Estimated Enrollment: 250
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)
Groups/Cohorts
Alcohol- dependent patients
Detoxified alcohol- dependent patients in an inpatient setting
Control group
Age- and gender matched healthy controls

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Detoxified alcohol- dependent patients and age- and gender matched healthy controls living in Germany

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01679145

Locations
Germany
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
Sponsors and Collaborators
Technische Universität Dresden
Charite University, Berlin, Germany
University Hospital Carl Gustav Carus
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT01679145     History of Changes
Other Study ID Numbers: HE2597/141;ZI1119/31;WI709/101
Study First Received: August 31, 2012
Last Updated: March 20, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Technische Universität Dresden:
Reward- based learning
Pavlovian-to-instrumental transfer
Functional imaging
Relapse risk

Additional relevant MeSH terms:
Alcohol Drinking
Alcoholism
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014