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: 9.1 Level: LLT Cl
Conditions
Interventions
Trade Name: Cycloserine
Pharmaceutical Form: Capsule*
INN or Proposed INN: CYCLOSERINE
CAS Number: 68417
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmac
Sponsors
Central Institute of Mental Health
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Germany
Outcome results
None listed