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

NCT02228486 | Unknown

• 1 other identifier: aCR
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Dependency

Outcome Measures

Primary Outcomes (1)

• alcohol consumption days

  six months

Secondary Outcomes (2)

• Maximum subjective alcohol craving during alcohol cue-exposure (10-point scale)

  5 weeks

• subjective rating of self-efficacy (score on a 10 item-scale)

  6 months

Other Outcomes (3)

• Hemodynamics in the orbitofrontal cortex and the dorsolateral prefrontal cortex during cue-exposure

  5 weeks

• heart-rate variability during alcohol cue-exposure

  5 weeks

• Skin conductance level during alcohol cue exposure

  5 weeks

Study Arms (3)

Cue Exposure Therapy and verum tDCS

ACTIVE COMPARATOR

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; Behavioral: Cue Exposure Therapy

Cue Exposure Therapy and sham tDCS

PLACEBO COMPARATOR

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

Waiting list control group

NO INTERVENTION

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

Interventions

tDCS DEVICE

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)

Also known as: transcrancial direct currenct stimulation

Cue Exposure Therapy and verum tDCS

Cue Exposure Therapy BEHAVIORAL

5 weeks (9 sessions) of cue-exposure therapy with preferred alcoholic beverage (see also above)

Also known as: Cue-Exposure Training

Cue Exposure Therapy and sham tDCS; Cue Exposure Therapy and verum tDCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

Department of Psychiatry and Psychotherapy, University Hospital Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

MeSH Terms

Conditions

Alcoholism

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Ann-Christine Ehlis, PhD

  University Hospital Tuebingen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Agnes Kroczek, Dipl.-Psych.

CONTACT

0049 7071 29; Agnes.Kroczek@med.uni-tuebingen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: August 15, 2014
• First Posted: August 29, 2014
• Study Start: August 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 29, 2014

Record last verified: 2014-08

Locations

DE (1)