Clinical trial NCT00926900: The Role of the Glutamatergic System in the Extinction of Conditioned Reinforcement Processes
Official title: The Role of the Glutamatergic System in the Extinction of Conditioned Reinforcement Processes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Alcohol Drinking
Keywords: Alcoholism
D-cycloserine
extinction
cue-exposure
Lead sponsor: Central Institute of Mental Health, Mannheim
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2009-06-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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 -

Primary outcomes:
measure: reduction in cue-reactivity to alcohol-associated stimuli assessed by functional magnetic resonance imaging
timeFrame: following completion of cue-exposure therapy
Secondary outcomes:
measure: time to first severe relapse to alcohol consumption
timeFrame: at 3 and 6 months after treatment completion
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Central Institute of Mental Health
Study officials:
affiliation: Central Institute of Mental Health, Department of Addictive Behavior and Addiction Medicine
name: Falk Kiefer, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Strosche A, Zhang X, Kirsch M, Hermann D, Ende G, Kiefer F, Vollstadt-Klein S. Investigation of brain functional connectivity to assess cognitive control over cue-processing in Alcohol Use Disorder. Addict Biol. 2021 Jan;26(1):e12863. doi: 10.1111/adb.12863. Epub 2020 Jan 6.
citation: Vollstadt-Klein S, Loeber S, Kirsch M, Bach P, Richter A, Buhler M, von der Goltz C, Hermann D, Mann K, Kiefer F. Effects of cue-exposure treatment on neural cue reactivity in alcohol dependence: a randomized trial. Biol Psychiatry. 2011 Jun 1;69(11):1060-6. doi: 10.1016/j.biopsych.2010.12.016. Epub 2011 Feb 3.