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

Alcohol Drinking Clinical Trial

— SFB636D6  

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00926900
• Other study ID #: SFB636 D6 2006-007090-72
• Status: Unknown status
• Phase: Phase 2/Phase 3
• First received: June 22, 2009
• Last updated: November 24, 2011
• Start date: March 2009

Study information

• Verified date: November 2011
• Source: Central Institute of Mental Health, Mannheim
• Contact: Falk Kiefer, Professor
• Phone: +49 621 1703 3522
• Email: falk.kiefer[@]zi-mannheim.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 80
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Alcohol Drinking

Intervention

Drug:
• D-cycloserine
50 mg at approximately 1.5 hours prior to cue-exposure training sessions
• Placebo
Placebo

Locations

Country	Name	City	State
Germany	Central Institute of Mental Health	Mannheim

Sponsors (2)

Lead Sponsor	Collaborator
Central Institute of Mental Health, Mannheim	German Research Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction in cue-reactivity to alcohol-associated stimuli assessed by functional magnetic resonance imaging		following completion of cue-exposure therapy
Secondary	time to first severe relapse to alcohol consumption		at 3 and 6 months after treatment completion

External Links

•   website of the Central Institute of Mental Health