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Learning and Relapse Risk in Alcohol Dependence (FP2) (LeAD_FP2)

Primary Purpose

Alcohol Use Disorder

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Zooming Joystick Task

Zooming Joystick Task (Placebo)

About this trial

This is an interventional treatment trial for Alcohol Use Disorder focused on measuring Pavlovian conditioning, Operant conditioning, Pavlovian-to-instrumental transfer, Functional imaging, Relapse risk, Behavioural Intervention

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Men and women aged 18-65 years
alcohol dependence/alcohol use disorder according to ICD-10 and alcohol-use disorder according to DSM-5
Minimum of 72 hours of abstinence, maximum of 21 days of abstinence
Minimum of three years with alcohol dependence/alcohol use disorder
Low severity of withdrawal symptoms
Ability to provide fully informed consent and to use self-rating scales
Sufficient understanding of the German language

Exclusion Criteria:

Lifetime history of DSM-IV bipolar, psychotic disorder, or substance dependence other than nicotine dependence. Patients may have had lifetime alcohol dependence/alcohol use disorder diagnoses.
Current threshold DSM-IV diagnosis of any of the following disorders: current (hypo)manic episode, major depressive disorder, generalized anxiety disorder, PTSD, borderline personality disorder, or obsessive compulsive disorder
History of substance dependence other than alcohol or nicotine dependence
Current substance use other than nicotine and alcohol as evinced by positive urine test
History of severe head trauma or other severe central neurological disorder (dementia, Parkinson's disease, multiple sclerosis)
Pregnancy or nursing infants
Any alcohol intake within the last 24 hours
Use of medications or drugs known to interact with the central nervous system within the last 10 days, except detoxification treatment with benzodiazepines or clomethiazole, with testing at least four half-lives post last intake

Sites / Locations

Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden
Charité - Universitätsmedizin Berlin
Technische Universität Dresden

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Placebo Intervention

Arm Description

In the "verum treatment condition", i.e. Zooming Joystick Task, 90% of all alcohol-related pictures appear in the landscape format and hence are trained to be pushed away.

In the placebo condition, i.e. Zooming Joystick Task (Placebo), alcohol picture are as often pushed away as pulled towards the subject.

Outcomes

Primary Outcome Measures

relapse to heavy drinking

defined as the consumption of over 60g of alcohol per occasion in men and of over 40g of alcohol in women

Secondary Outcome Measures

amount of alcohol intake during the follow-up period

Timeline Followback interview for each day during the follow-up period

blood oxygenation level-dependent (BOLD) signal

Full Information

NCT ID

NCT02615977

First Posted

November 20, 2015

Last Updated

July 22, 2020

Sponsor

Technische Universität Dresden

Collaborators

Charite University, Berlin, Germany, University Hospital Carl Gustav Carus

1. Study Identification

Unique Protocol Identification Number

NCT02615977

Brief Title

Learning and Relapse Risk in Alcohol Dependence (FP2)

Acronym

LeAD_FP2

Official Title

Learning and Decision Making as Predictors of Treatment Outcome in Alcohol Use Disorder (Funding Period 2)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

April 2015 (Actual)

Primary Completion Date

August 2018 (Actual)

Study Completion Date

June 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Technische Universität Dresden

Collaborators

Charite University, Berlin, Germany, University Hospital Carl Gustav Carus

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The investigators will examine clinical alterations in learning and automated approach behaviour and their neurobiological correlates in alcohol-dependent patients and healthy social drinkers and assess whether they are affected by a Zooming Joystick Training (ZJT; randomized "verum" versus "placebo" training) which trains subjects to habitually push alcohol pictures away. The investigators will test whether activations following treatment predict relapse rate (primary outcome measure) and the prospective amount of alcohol intake (secondary outcome measure) within a six-month follow-up period. Using fMRI, the investigators will use the Pavlovian-to-Instrumental-Transfer (PIT) paradigm established during the first funding period to distinguish the effects of appetitive, aversive, and drug-related Pavlovian cues on automated instrumental approach behaviour and to assess ZJT training effects comparing functional activation before and after ZJT training. The investigators will also scan subjects during performance of a short standard working memory task. Behaviourally, aspects of impulsivity will be assessed with the Value-Based Decision Making (VBDM) Battery. Scanning will be repeated after ZJT training to assess its effects on the neural correlates of Pavlovian-to-Instrumental transfer (PIT).

Detailed Description

This Project will examine 130 detoxified alcohol-dependent patients and 40 age- and gender matched controls. All subjects will be treated with Zooming Joystick Task (ZJT) training to alter a habitual alcohol cue approach bias. The primary aim of this project is to assess which behavioural and neuroimaging alterations (fMRI) associated with reward-based learning are altered by ZJT treatment and which alterations predict treatment outcome (primary outcome: relapse, secondary outcome: amount of alcohol intake) within the follow-up period of 6 months, how these alterations interact with clinical and psychosocial factors that can modify relapse risk, and to provide data for genetic and imaging analyses and modelling. Furthermore, the investigators will explore gender effects on functional imaging parameters of learning. Patients will be detoxified in an inpatient setting, receive six sessions of the ZJT in a randomized placebo controlled design and will be followed for six months using the Time-Line Follow-Back Procedure. Clinical assessments, behavioural paradigms of learning, and brain imaging will be carried out within at least four half-lives after any psychotropic medication. Subjects will undergo medical management with biweekly follow-ups and predefined inclusion and exclusion criteria as previously described. Functional imaging paradigms will be applied, assessing Pavlovian-to-instrumental transfer, habitual versus goal directed behaviour and working memory. The investigators will associate model parameters of learning with functional activation and prospective intake controlling for comorbidity, psychosocial and neurobiological disease severity markers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Use Disorder

Keywords

Pavlovian conditioning, Operant conditioning, Pavlovian-to-instrumental transfer, Functional imaging, Relapse risk, Behavioural Intervention

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

258 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

In the "verum treatment condition", i.e. Zooming Joystick Task, 90% of all alcohol-related pictures appear in the landscape format and hence are trained to be pushed away.

Arm Title

Placebo Intervention

Arm Type

Placebo Comparator

Arm Description

In the placebo condition, i.e. Zooming Joystick Task (Placebo), alcohol picture are as often pushed away as pulled towards the subject.

Intervention Type

Behavioral

Intervention Name(s)

Zooming Joystick Task

Other Intervention Name(s)

Alcohol Approach Avoidance Task

Intervention Description

Subjects are instructed to use the joystick to pull all pictures (alcoholic and non-alcoholic beverages) towards them that appear in the portrait format, while pictures in a landscape format are pushed away. Half of the pictures are alcohol-related and the other half is not. The assignment of stimuli (alcohol versus neutral) to the picture format (portrait versus landscape) is manipulated (see 'Study Arm' descriptions). Arousal and valence of the alcohol and non-alcohol pictures is rated as previously described. The investigators will apply six sessions of ZJT training, as this number has been proven sufficient for reducing relapse rates.

Intervention Type

Behavioral

Intervention Name(s)

Zooming Joystick Task (Placebo)

Other Intervention Name(s)

Alcohol Approach Avoidance Task (Placebo)

Intervention Description

Primary Outcome Measure Information:

Title

relapse to heavy drinking

Description

defined as the consumption of over 60g of alcohol per occasion in men and of over 40g of alcohol in women

Time Frame

6 months

Secondary Outcome Measure Information:

Title

amount of alcohol intake during the follow-up period

Description

Timeline Followback interview for each day during the follow-up period

Time Frame

6 months

Title

blood oxygenation level-dependent (BOLD) signal

Time Frame

at assessment and after last training (approx. 2 weeks after assessment)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men and women aged 18-65 years alcohol dependence/alcohol use disorder according to ICD-10 and alcohol-use disorder according to DSM-5 Minimum of 72 hours of abstinence, maximum of 21 days of abstinence Minimum of three years with alcohol dependence/alcohol use disorder Low severity of withdrawal symptoms Ability to provide fully informed consent and to use self-rating scales Sufficient understanding of the German language Exclusion Criteria: Lifetime history of DSM-IV bipolar, psychotic disorder, or substance dependence other than nicotine dependence. Patients may have had lifetime alcohol dependence/alcohol use disorder diagnoses. Current threshold DSM-IV diagnosis of any of the following disorders: current (hypo)manic episode, major depressive disorder, generalized anxiety disorder, PTSD, borderline personality disorder, or obsessive compulsive disorder History of substance dependence other than alcohol or nicotine dependence Current substance use other than nicotine and alcohol as evinced by positive urine test History of severe head trauma or other severe central neurological disorder (dementia, Parkinson's disease, multiple sclerosis) Pregnancy or nursing infants Any alcohol intake within the last 24 hours Use of medications or drugs known to interact with the central nervous system within the last 10 days, except detoxification treatment with benzodiazepines or clomethiazole, with testing at least four half-lives post last intake

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andreas Heinz, Prof PhD MD

Organizational Affiliation

Charite University, Berlin, Germany

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Hans-Ulrich Wittchen, Prof PhD

Organizational Affiliation

Technische Universität Dresden, Dresden, Germany

Official's Role

Study Director

Facility Information:

Facility Name

Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden

City

Dresden

State/Province

Saxony

ZIP/Postal Code

01307

Country

Germany

Facility Name

Charité - Universitätsmedizin Berlin

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Technische Universität Dresden

City

Dresden

ZIP/Postal Code

01187

Country

Germany

12. IPD Sharing Statement

Links:

URL

http://www.lead-studie.de/

Description

Official study group website

URL

http://gepris.dfg.de/gepris/projekt/186318919?language=en

Description

English study description

Learn more about this trial

Learning and Relapse Risk in Alcohol Dependence (FP2)

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