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

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00926900
Acronym
SFB636D6
Enrollment
80
Registered
2009-06-24
Start date
2009-03-31
Completion date
Unknown
Last updated
2011-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Drinking

Keywords

Alcoholism, D-cycloserine, extinction, cue-exposure

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.

Interventions

DRUGD-cycloserine

50 mg at approximately 1.5 hours prior to cue-exposure training sessions

DRUGPlacebo

Placebo

Sponsors

German Research Foundation
CollaboratorOTHER
Central Institute of Mental Health, Mannheim
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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 -

Design outcomes

Primary

MeasureTime frame
reduction in cue-reactivity to alcohol-associated stimuli assessed by functional magnetic resonance imagingfollowing completion of cue-exposure therapy

Secondary

MeasureTime frame
time to first severe relapse to alcohol consumptionat 3 and 6 months after treatment completion

Countries

Germany

Contacts

Primary ContactFalk Kiefer, Professor
falk.kiefer@zi-mannheim.de+49 621 1703 3522

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026