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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02228486
Enrollment
48
Registered
2014-08-29
Start date
2014-08-31
Completion date
2016-08-31
Last updated
2014-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Dependency

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.

Interventions

DEVICEtDCS

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)

BEHAVIORALCue Exposure Therapy

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

Sponsors

University Hospital Tuebingen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
alcohol consumption dayssix months

Secondary

MeasureTime frameDescription
Maximum subjective alcohol craving during alcohol cue-exposure (10-point scale)5 weeksDuring alcohol cue-exposure, subjects rate the subjective craving regularly on a scale from 0 to 10.
subjective rating of self-efficacy (score on a 10 item-scale)6 monthsquestionnaire (General Self-Efficacy Scale, Schwarzer & Jerusalem, 1995)

Other

MeasureTime frameDescription
Hemodynamics in the orbitofrontal cortex and the dorsolateral prefrontal cortex during cue-exposure5 weeksWith 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
heart-rate variability during alcohol cue-exposure5 weekslow frequency/ high frequency (LF/HF) power ratio and standard deviation of the duration between R-peaks (RR) during cue-exposure
Skin conductance level during alcohol cue exposure5 weeksskin conductance level (SCL) in Mikrosiemens (μS)

Countries

Germany

Contacts

Primary ContactAgnes Kroczek, Dipl.-Psych.
Agnes.Kroczek@med.uni-tuebingen.de0049 7071 29

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026