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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

About this trial

This is an interventional basic science trial for Alcohol Drinking focused on measuring Alcoholism, D-cycloserine, extinction, cue-exposure

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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

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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