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

Alcohol Dependency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02228486
• Other study ID #: aCR
• Status: Recruiting
• Phase: N/A
• First received: August 15, 2014
• Last updated: August 26, 2014
• Start date: August 2014
• Est. completion date: August 2016

Study information

• Verified date: August 2014
• Source: University Hospital Tuebingen
• Contact: Agnes Kroczek, Dipl.-Psych.
• Phone: 0049 7071 29
• Email: Agnes.Kroczek[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependency
• Alcoholism

Intervention

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)

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

Locations

Country	Name	City	State
Germany	Department of Psychiatry and Psychotherapy, University Hospital Tuebingen	Tuebingen	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	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	No
Other	Skin conductance level during alcohol cue exposure	skin conductance level (SCL) in Mikrosiemens (µS)	5 weeks	No
Primary	alcohol consumption days		six months	No
Secondary	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	No
Secondary	subjective rating of self-efficacy (score on a 10 item-scale)	questionnaire (General Self-Efficacy Scale, Schwarzer & Jerusalem, 1995)	6 months	No