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
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
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Germany | Department of Psychiatry and Psychotherapy, University Hospital Tuebingen | Tuebingen | Baden-Württemberg |
Lead Sponsor | Collaborator |
---|---|
University Hospital Tuebingen |
Germany,
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 |
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