The Role of the Glutamatergic System in the Extinction of Conditioned Reinforcement Processes

Study Overview
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Brief Summary
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The aim of this project is to explore whether the extinction of cue-reactivity following a cue-exposure based intervention in volunteers with an alcohol dependence is facilitated by drugs that increase NMDA-receptor function. It is hypothesised that targeted treatment with D-Cycloserine prior to each extinction training session enhances the effects on cue-reactivity. Further, a significant correlation between the reduction of cue-reactivity and both reduced craving and relapse probability is expected.

Official Title
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The Role of the Glutamatergic System in the Extinction of Conditioned Reinforcement Processes

Conditions
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Alcohol Drinking

Intervention / Treatment
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* Drug: D-cycloserine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: current DSM-IV/ ICD-10 diagnosis of alcohol dependence controlled abstinence for a period of 5 to 21 days following admission to inpatient detoxification or day-clinic care women (in childbearing age): use of a highly effective method of contraception normal or corrected-to-normal vision ability to provide written informed consent Exclusion Criteria: diagnosis of additional axis I or II disorders (according to DSM-IV( ICD- 10 criteria) either currently or within the past 12 months (except nicotine dependence) positive drug screening current medication with anti-convulsive or psychotropic drugs MRI ineligibility sensitivity to study medication as evidenced by a history of adverse drug experience severe withdrawal symptoms (e.g. convulsions, delirium) disposition towards experiencing convulsions/ epilepsy history of schizophrenic disorders/ affective psychosis neurological diseases that might affect the dopaminergic, limbic and frontal cortices or extrapyramidal motor functioning major diseases (e.g. diabetes, liver cirrhosis, heart disease) physical illness interfering with study procedures or affecting study outcomes pregnancy (positive test results)/ lactation period suicidal tendencies/ increased risk that others might be harmed -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: D-cycloserine<br> | Drug: D-cycloserine<br>* 50 mg at approximately 1.5 hours prior to cue-exposure training sessions<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction in cue-reactivity to alcohol-associated stimuli assessed by functional magnetic resonance imaging |  | following completion of cue-exposure therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to first severe relapse to alcohol consumption |  | at 3 and 6 months after treatment completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcoholism, D-cycloserine, extinction, cue-exposure