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

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ClinicalTrials.gov Identifier: NCT02228486
Recruitment Status : Unknown
Verified August 2014 by Dr. Ann-Christine Ehlis, University Hospital Tuebingen.
Recruitment status was:  Recruiting
First Posted : August 29, 2014
Last Update Posted : August 29, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Ann-Christine Ehlis, University Hospital Tuebingen

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.

Condition or disease Intervention/treatment Phase
Alcohol Dependency Device: tDCS Behavioral: Cue Exposure Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Alcohol Cue-Reactivity in Patients With Alcohol Dependency and Effects of Transcranial Direct Current Stimulation (tDCS) on Cue-exposure Therapy
Study Start Date : August 2014
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Cue Exposure Therapy and verum tDCS
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).
Device: tDCS
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)
Other Name: transcrancial direct currenct stimulation

Behavioral: Cue Exposure Therapy
5 weeks (9 sessions) of cue-exposure therapy with preferred alcoholic beverage (see also above)
Other Name: Cue-Exposure Training

Placebo Comparator: Cue Exposure Therapy and sham tDCS
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.
Behavioral: Cue Exposure Therapy
5 weeks (9 sessions) of cue-exposure therapy with preferred alcoholic beverage (see also above)
Other Name: Cue-Exposure Training

No Intervention: Waiting list control group
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



Primary Outcome Measures :
  1. alcohol consumption days [ Time Frame: six months ]

Secondary Outcome Measures :
  1. Maximum subjective alcohol craving during alcohol cue-exposure (10-point scale) [ Time Frame: 5 weeks ]
    During alcohol cue-exposure, subjects rate the subjective craving regularly on a scale from 0 to 10.

  2. subjective rating of self-efficacy (score on a 10 item-scale) [ Time Frame: 6 months ]
    questionnaire (General Self-Efficacy Scale, Schwarzer & Jerusalem, 1995)


Other Outcome Measures:
  1. Hemodynamics in the orbitofrontal cortex and the dorsolateral prefrontal cortex during cue-exposure [ Time Frame: 5 weeks ]
    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

  2. heart-rate variability during alcohol cue-exposure [ Time Frame: 5 weeks ]
    low frequency/ high frequency (LF/HF) power ratio and standard deviation of the duration between R-peaks (RR) during cue-exposure

  3. Skin conductance level during alcohol cue exposure [ Time Frame: 5 weeks ]
    skin conductance level (SCL) in Mikrosiemens (μS)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228486


Contacts
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Contact: Agnes Kroczek, Dipl.-Psych. 0049 7071 29 ext 82627 Agnes.Kroczek@med.uni-tuebingen.de

Locations
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Germany
Department of Psychiatry and Psychotherapy, University Hospital Tuebingen Recruiting
Tuebingen, Baden-Württemberg, Germany, 72076
Contact: Agnes Kroczek, Dipl.-Psych.    0049 7071 29 ext 82627    Agnes.Kroczek@med.uni-tuebingen.de   
Contact: Ann-Christine Ehlis, PhD    0049 7071 29 ext 87103    Ann-Christine.Ehlis@med.uni-tuebingen.de   
Principal Investigator: Ann-Christine Ehlis, Dr.         
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
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Principal Investigator: Ann-Christine Ehlis, PhD University Hospital Tuebingen

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Responsible Party: Dr. Ann-Christine Ehlis, Dr., University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT02228486    
Other Study ID Numbers: aCR
First Posted: August 29, 2014    Key Record Dates
Last Update Posted: August 29, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs