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

Alcohol Cue-Reactivity in Patients With Alcohol Dependency and Effects of Transcranial Direct Current Stimulation (tDCS) on Cue-exposure Therapy

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.

Study Overview

• Status: Unknown
• Conditions: Alcohol Dependency
• Intervention / Treatment: Device: tDCS; Behavioral: Cue Exposure Therapy

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Tuebingen, Baden-Württemberg, Germany, 72076
      • Recruiting
      • Department of Psychiatry and Psychotherapy, University Hospital Tuebingen
      • Contact: Agnes Kroczek, Dipl.-Psych.; Phone Number: 82627 0049 7071 29; Email: Agnes.Kroczek@med.uni-tuebingen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: transcrancial direct currenct stimulation; Behavioral: Cue Exposure Therapy; 5 weeks (9 sessions) of cue-exposure therapy with preferred alcoholic beverage (see also above); Other Names: 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
alcohol consumption days	six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 weeks
subjective rating of self-efficacy (score on a 10 item-scale)	questionnaire (General Self-Efficacy Scale, Schwarzer & Jerusalem, 1995)	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodynamics in the orbitofrontal cortex and the dorsolateral prefrontal cortex during cue-exposure	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	5 weeks
heart-rate variability during alcohol cue-exposure	low frequency/ high frequency (LF/HF) power ratio and standard deviation of the duration between R-peaks (RR) during cue-exposure	5 weeks
Skin conductance level during alcohol cue exposure	skin conductance level (SCL) in Mikrosiemens (μS)	5 weeks

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Investigators: Principal Investigator: Ann-Christine Ehlis, PhD, University Hospital Tuebingen

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Anticipated): August 1, 2016
• Study Completion (Anticipated): August 1, 2016

Study Registration Dates

• First Submitted: August 15, 2014
• First Submitted That Met QC Criteria: August 26, 2014
• First Posted (Estimate): August 29, 2014

Study Record Updates

• Last Update Posted (Estimate): August 29, 2014
• Last Update Submitted That Met QC Criteria: August 26, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism
• Other Study ID Numbers: aCR