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Clinical Trials/NCT02228486
NCT02228486
Unknown
Not Applicable

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

University Hospital Tuebingen1 site in 1 country48 target enrollmentStarted: August 2014Last updated:

Overview

Phase
Not Applicable
Enrollment
48
Locations
1
Primary Endpoint
alcohol consumption days

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

alcohol consumption days

Time Frame: six months

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr. Ann-Christine Ehlis

Dr.

University Hospital Tuebingen

Study Sites (1)

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