Learning and Relapse Risk in Alcohol Dependence

Alcohol Use Disorders Clinical Trial

— LeAD  

Official title:

Learning Mechanisms as Predictors of Treatment Outcome in Alcohol- Dependent Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01679145
• Other study ID #: HE2597/141;ZI1119/31;WI709/101
• 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

• Alcohol Drinking
• Alcohol Use Disorders

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

External Links

•   English study description
•   Official study group website