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Relapse Prevention in Alcohol Dependency by Transcranial Direct Current Stimulation Supported Cue Exposure Therapy

Primary Purpose

Alcohol Dependency

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
tDCS
Cue Exposure Therapy
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of an alcohol dependence (F10.2)
  • abstinence motivation

Exclusion Criteria:

  • epileptic seizures
  • acute psychotic episode
  • another substance use disorder besides nicotine dependency (F17.2)
  • acute withdrawal symptoms

Sites / Locations

  • Department of Psychiatry and Psychotherapy, University Hospital TuebingenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

No Intervention

Arm Label

Cue Exposure Therapy and verum tDCS

Cue Exposure Therapy and sham tDCS

Waiting list control group

Arm Description

During alcohol cue exposure, an active tDCS with a duration of 15 minutes and 2 mA is applied to the left dorsolateral prefrontal cortex (F3, anode) and a reference electrode placed over Fp2 (electrode positions determined by the international 10-20 system). The electrodes are rectangular (35cm2).

During alcohol cue exposure, a placebo tDCS is used with electrodes placed over the left dorsolateral prefrontal cortex (F3, anode) and a reference electrode placed over Fp2 (electrode positions determined by the international 10-20 system). The electrodes are rectangular (35cm2). There is a 20 second ramp going up until 2 mA and back to 0 again at the beginning and the end of the placebo stimulation with no active stimulation during the cue exposure.

The Cue-Reactivity of patients assigned to this arm will be measured twice with an interval of 5 weeks. Afterwards, patients will take part in the cue exposure therapy like subjects assigned to the active arms of the study

Outcomes

Primary Outcome Measures

alcohol consumption days

Secondary Outcome Measures

Maximum subjective alcohol craving during alcohol cue-exposure (10-point scale)
During alcohol cue-exposure, subjects rate the subjective craving regularly on a scale from 0 to 10.
subjective rating of self-efficacy (score on a 10 item-scale)
questionnaire (General Self-Efficacy Scale, Schwarzer & Jerusalem, 1995)

Full Information

First Posted
August 15, 2014
Last Updated
August 26, 2014
Sponsor
University Hospital Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT02228486
Brief Title
Relapse Prevention in Alcohol Dependency by Transcranial Direct Current Stimulation Supported Cue Exposure Therapy
Official Title
Alcohol Cue-Reactivity in Patients With Alcohol Dependency and Effects of Transcranial Direct Current Stimulation (tDCS) on Cue-exposure Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Tuebingen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Relapse is a major risk in substance abuse disorders, which is closely related to craving for a substance, describing a strong urge for consumption. Cue-exposure therapy is an intervention aiming at the reduction of perceived craving by repeated confrontation. It is based on the assumption that craving drops after repeated exposure without the reinforcing experience elicited by consumption. In the present study, patients with alcohol dependency take part in nine cue-exposure training sessions. Each session consists of mood induction reflecting a high risk situation with subsequent in vivo confrontation with one's preferred alcoholic beverage followed by the training of coping strategies. During the cue-exposure, patients focus on perceiving automatic responses to alcohol-related cues. We hypothesize that especially patients exhibiting initially high reactions to such cues should profit from this intervention the most. The reactions are measured on a subjective (craving) and physiological level (hemodynamics of the prefrontal cortex, heart rate variability, electrodermal activity). Furthermore, we want to strengthen the expected training effects during the cue-exposure by an activating transcranial direct current stimulation of the dorsolateral prefrontal cortex, which has been shown to be hypoactive in substance abuse disorders. We investigate how the cue-exposure training affects the processing of alcoholic cues (cue-reactivity) and its relation to clinical symptoms of alcohol dependency.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cue Exposure Therapy and verum tDCS
Arm Type
Active Comparator
Arm Description
During alcohol cue exposure, an active tDCS with a duration of 15 minutes and 2 mA is applied to the left dorsolateral prefrontal cortex (F3, anode) and a reference electrode placed over Fp2 (electrode positions determined by the international 10-20 system). The electrodes are rectangular (35cm2).
Arm Title
Cue Exposure Therapy and sham tDCS
Arm Type
Placebo Comparator
Arm Description
During alcohol cue exposure, a placebo tDCS is used with electrodes placed over the left dorsolateral prefrontal cortex (F3, anode) and a reference electrode placed over Fp2 (electrode positions determined by the international 10-20 system). The electrodes are rectangular (35cm2). There is a 20 second ramp going up until 2 mA and back to 0 again at the beginning and the end of the placebo stimulation with no active stimulation during the cue exposure.
Arm Title
Waiting list control group
Arm Type
No Intervention
Arm Description
The Cue-Reactivity of patients assigned to this arm will be measured twice with an interval of 5 weeks. Afterwards, patients will take part in the cue exposure therapy like subjects assigned to the active arms of the study
Intervention Type
Device
Intervention Name(s)
tDCS
Other Intervention Name(s)
transcrancial direct currenct stimulation
Intervention Description
2 mA (verum group) over the left dorsolateral prefrontal cortex (F3, anodal), 15 min; 10 seconds ramp in verum and sham group (see also above)
Intervention Type
Behavioral
Intervention Name(s)
Cue Exposure Therapy
Other Intervention Name(s)
Cue-Exposure Training
Intervention Description
5 weeks (9 sessions) of cue-exposure therapy with preferred alcoholic beverage (see also above)
Primary Outcome Measure Information:
Title
alcohol consumption days
Time Frame
six months
Secondary Outcome Measure Information:
Title
Maximum subjective alcohol craving during alcohol cue-exposure (10-point scale)
Description
During alcohol cue-exposure, subjects rate the subjective craving regularly on a scale from 0 to 10.
Time Frame
5 weeks
Title
subjective rating of self-efficacy (score on a 10 item-scale)
Description
questionnaire (General Self-Efficacy Scale, Schwarzer & Jerusalem, 1995)
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Hemodynamics in the orbitofrontal cortex and the dorsolateral prefrontal cortex during cue-exposure
Description
With near-infrared spectroscopy, changes in the concentrations of oxygenated (O2HB) and deoxygenated (HHb) haemoglobin are assessed (in mmol*mm), peaks in those concentrations are evaluated
Time Frame
5 weeks
Title
heart-rate variability during alcohol cue-exposure
Description
low frequency/ high frequency (LF/HF) power ratio and standard deviation of the duration between R-peaks (RR) during cue-exposure
Time Frame
5 weeks
Title
Skin conductance level during alcohol cue exposure
Description
skin conductance level (SCL) in Mikrosiemens (μS)
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of an alcohol dependence (F10.2) abstinence motivation Exclusion Criteria: epileptic seizures acute psychotic episode another substance use disorder besides nicotine dependency (F17.2) acute withdrawal symptoms
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Agnes Kroczek, Dipl.-Psych.
Phone
0049 7071 29
Ext
82627
Email
Agnes.Kroczek@med.uni-tuebingen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann-Christine Ehlis, PhD
Organizational Affiliation
University Hospital Tuebingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry and Psychotherapy, University Hospital Tuebingen
City
Tuebingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agnes Kroczek, Dipl.-Psych.
Phone
0049 7071 29
Ext
82627
Email
Agnes.Kroczek@med.uni-tuebingen.de
First Name & Middle Initial & Last Name & Degree
Ann-Christine Ehlis, PhD
Phone
0049 7071 29
Ext
87103
Email
Ann-Christine.Ehlis@med.uni-tuebingen.de
First Name & Middle Initial & Last Name & Degree
Ann-Christine Ehlis, Dr.

12. IPD Sharing Statement

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Relapse Prevention in Alcohol Dependency by Transcranial Direct Current Stimulation Supported Cue Exposure Therapy

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