The role of the glutamatergic system in the extinction of conditioned reinforcement processes - The role of the glutamatergic system in the extinction of conditioned reinforcement processes
- Conditions
- Alcohol-dependence is an important factor contributing to health care costs. Alcohol-dependent patients show conditioned reactions to stimuli that were associated with substance consumption and several studies demonstrated that these reactions are related to relapse after treatment. Based on recent research with phobic patients the aim of this clinical trial is to study whether the combination of extinction training with Cycloserine enhances treatment efficacy.MedDRA version: 9.1Level: LLTClassification code 10001594Term: Alcohol dependence syndrome
- Registration Number
- EUCTR2006-007090-72-DE
- Lead Sponsor
- Central Institute of Mental Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Men and women between the age of 18 and 65 years; alcohol dependent according to DSM-IV criteria; controlled abstinent for 5-21 days after admission to inpatient detoxification (controlled with breathalyser), right-handed, able to speak the German language, able to accurately watch visual stimuli in the scanner environment (best corrected visual acuity < 0.8; Landolt C rings), and provide informed consent. Patients will be selected based on evidence of conditioned cue-related reactions at pre-treatment assessment using the alcohol-attentional bias measured with a dot-probe task.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria include psychiatric Axis I and II disorders except abuse and dependence of alcohol and nicotine, seizure disorders, major diseases such as severe diabetes or liver cirrhosis; sensitivity to study medication (DCS) as evidenced by a history of adverse drug experience, pace maker or implanted metal that would prevent an MRI examination; positive drug screening (opioids, cannabinoids, benzodiazepines, barbiturates, cocaine, amphetamines), any current psychoactive medication, pregnancy, women with childbearing potential, and suicidal tendencies.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary objective of the trial is to answer the question whether in abstinent alcohol-dependent patients the application of Cycloserine facilitates extinction of conditioned drug-associated responses. ;Secondary Objective: Secondary objective is to study whether the extinction of conditioned drug-associated responses is associated with a reduction of relapse after treatment. ;Primary end point(s): The effects of extinction training and the facilitation effect of Cycloserine on extinction of conditoned reactions towards alcohol cues will be assessed in a pre-post design using a modified alcohol version of a dot-probe task and functional magnetic resonance imaging (fMRI). Dot-probe task and fMRI scan will be performed twice, pre and post nine sessions of extinction training. Secondary measures will be abstinence duration and craving for alcohol (OCDS) during follow up (12 weeks).
- Secondary Outcome Measures
Name Time Method