The Role of the Glutamatergic System in the Extinction of Conditioned Reinforcement Processes (SFB636D6)
Primary Purpose
Alcohol Drinking
Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
D-cycloserine
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Alcohol Drinking focused on measuring Alcoholism, D-cycloserine, extinction, cue-exposure
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 -
Sites / Locations
- Central Institute of Mental HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
D-cycloserine
Placebo
Arm Description
Outcomes
Primary Outcome Measures
reduction in cue-reactivity to alcohol-associated stimuli assessed by functional magnetic resonance imaging
Secondary Outcome Measures
time to first severe relapse to alcohol consumption
Full Information
NCT ID
NCT00926900
First Posted
June 22, 2009
Last Updated
November 24, 2011
Sponsor
Central Institute of Mental Health, Mannheim
Collaborators
German Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00926900
Brief Title
The Role of the Glutamatergic System in the Extinction of Conditioned Reinforcement Processes
Acronym
SFB636D6
Official Title
The Role of the Glutamatergic System in the Extinction of Conditioned Reinforcement Processes
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
April 2012 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Institute of Mental Health, Mannheim
Collaborators
German Research Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking
Keywords
Alcoholism, D-cycloserine, extinction, cue-exposure
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
D-cycloserine
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
D-cycloserine
Intervention Description
50 mg at approximately 1.5 hours prior to cue-exposure training sessions
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
reduction in cue-reactivity to alcohol-associated stimuli assessed by functional magnetic resonance imaging
Time Frame
following completion of cue-exposure therapy
Secondary Outcome Measure Information:
Title
time to first severe relapse to alcohol consumption
Time Frame
at 3 and 6 months after treatment completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Falk Kiefer, Professor
Phone
+49 621 1703 3522
Email
falk.kiefer@zi-mannheim.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Falk Kiefer, Professor
Organizational Affiliation
Central Institute of Mental Health, Department of Addictive Behavior and Addiction Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Institute of Mental Health
City
Mannheim
ZIP/Postal Code
68159
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Falk Kiefer, Professor
Phone
+49 621 1703 3522
Email
falk.kiefer@zi-mannheim.de
First Name & Middle Initial & Last Name & Degree
Falk Kiefer, Professor
12. IPD Sharing Statement
Citations:
PubMed Identifier
31908107
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.
Results Reference
derived
PubMed Identifier
21292243
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.
Results Reference
derived
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The Role of the Glutamatergic System in the Extinction of Conditioned Reinforcement Processes
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