Clinical trial NCT02228486: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Alcohol Dependency
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2014-08-29
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: alcohol consumption days
timeFrame: six months
Secondary outcomes:
measure: Maximum subjective alcohol craving during alcohol cue-exposure (10-point scale)
timeFrame: 5 weeks
measure: subjective rating of self-efficacy (score on a 10 item-scale)
timeFrame: 6 months
Other outcomes:
measure: Hemodynamics in the orbitofrontal cortex and the dorsolateral prefrontal cortex during cue-exposure
timeFrame: 5 weeks
measure: heart-rate variability during alcohol cue-exposure
timeFrame: 5 weeks
measure: Skin conductance level during alcohol cue exposure
timeFrame: 5 weeks
Locations:
city: Tuebingen
country: Germany
facility: Department of Psychiatry and Psychotherapy, University Hospital Tuebingen
state: Baden-Württemberg
Study officials:
affiliation: University Hospital Tuebingen
name: Ann-Christine Ehlis, PhD
role: PRINCIPAL_INVESTIGATOR
References: