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

Phase 2

• Conditions: Alcohol Drinking
• Interventions: Drug: D-cycloserine; Drug: Placebo

• Registration Number: NCT00926900
• Lead Sponsor: Central Institute of Mental Health, Mannheim

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-06-22
• Study First Submitted QC: 2009-06-23
• Study First Posted: 2009-06-24
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-24
• Last Update Posted: 2011-11-28
• Primary Completion: 2012-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
D-cycloserine	D-cycloserine	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
reduction in cue-reactivity to alcohol-associated stimuli assessed by functional magnetic resonance imaging	following completion of cue-exposure therapy

Secondary Outcome Measures

Name	Time	Method
time to first severe relapse to alcohol consumption	at 3 and 6 months after treatment completion

Trial Locations

Locations (1)

Central Institute of Mental Health; 🇩🇪 Mannheim, Germany