MedDataX Logo

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

NCT ID: NCT02228486

Last Updated: 2014-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alcohol Dependency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cue Exposure Therapy and verum tDCS

During alcohol cue exposure, an active tDCS with a duration of 15 minutes and 2 mA is applied to the left dorsolateral prefrontal cortex (F3, anode) and a reference electrode placed over Fp2 (electrode positions determined by the international 10-20 system). The electrodes are rectangular (35cm2).

Group Type ACTIVE_COMPARATOR

tDCS

Intervention Type DEVICE

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)

Cue Exposure Therapy

Intervention Type BEHAVIORAL

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

Cue Exposure Therapy and sham tDCS

During alcohol cue exposure, a placebo tDCS is used with electrodes placed over the left dorsolateral prefrontal cortex (F3, anode) and a reference electrode placed over Fp2 (electrode positions determined by the international 10-20 system). The electrodes are rectangular (35cm2). There is a 20 second ramp going up until 2 mA and back to 0 again at the beginning and the end of the placebo stimulation with no active stimulation during the cue exposure.

Group Type PLACEBO_COMPARATOR

Cue Exposure Therapy

Intervention Type BEHAVIORAL

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

Waiting list control group

The Cue-Reactivity of patients assigned to this arm will be measured twice with an interval of 5 weeks. Afterwards, patients will take part in the cue exposure therapy like subjects assigned to the active arms of the study

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type DEVICE

Cue Exposure Therapy

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

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

transcrancial direct currenct stimulation Cue-Exposure Training

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Ann-Christine Ehlis

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ann-Christine Ehlis, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Tuebingen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Psychiatry and Psychotherapy, University Hospital Tuebingen

Tübingen, Baden-Wurttemberg, Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Agnes Kroczek, Dipl.-Psych.

Role: CONTACT

Phone: 0049 7071 29

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Agnes Kroczek, Dipl.-Psych.

Role: primary

Ann-Christine Ehlis, PhD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

aCR

Identifier Type: -

Identifier Source: org_study_id