E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001594 |
E.1.2 | Term | Alcohol dependence syndrome |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
Secondary objective is to study whether the extinction of conditioned drug-associated responses is associated with a reduction of relapse after treatment. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 < 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.
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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last visit of the last subject undergoing the trial |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |