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The Role of the Glutamatergic System in the Extinction of Conditioned Reinforcement Processes (SFB636D6)

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ClinicalTrials.gov Identifier: NCT00926900
Recruitment Status : Unknown
Verified November 2011 by Central Institute of Mental Health, Mannheim.
Recruitment status was:  Recruiting
First Posted : June 24, 2009
Last Update Posted : November 28, 2011
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Central Institute of Mental Health, Mannheim

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.


Condition or disease Intervention/treatment Phase
Alcohol Drinking Drug: D-cycloserine Drug: Placebo Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Role of the Glutamatergic System in the Extinction of Conditioned Reinforcement Processes
Study Start Date : March 2009
Estimated Primary Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol
Drug Information available for: Cycloserine
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: D-cycloserine Drug: D-cycloserine
50 mg at approximately 1.5 hours prior to cue-exposure training sessions
Placebo Comparator: Placebo Drug: Placebo
Placebo



Primary Outcome Measures :
  1. reduction in cue-reactivity to alcohol-associated stimuli assessed by functional magnetic resonance imaging [ Time Frame: following completion of cue-exposure therapy ]

Secondary Outcome Measures :
  1. time to first severe relapse to alcohol consumption [ Time Frame: at 3 and 6 months after treatment completion ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00926900


Contacts
Contact: Falk Kiefer, Professor +49 621 1703 3522 falk.kiefer@zi-mannheim.de

Locations
Germany
Central Institute of Mental Health Recruiting
Mannheim, Germany, 68159
Contact: Falk Kiefer, Professor    +49 621 1703 3522    falk.kiefer@zi-mannheim.de   
Principal Investigator: Falk Kiefer, Professor         
Sponsors and Collaborators
Central Institute of Mental Health, Mannheim
German Research Foundation
Investigators
Principal Investigator: Falk Kiefer, Professor Central Institute of Mental Health, Department of Addictive Behavior and Addiction Medicine

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Central Institute of Mental Health, Mannheim
ClinicalTrials.gov Identifier: NCT00926900     History of Changes
Other Study ID Numbers: SFB636 D6 2006-007090-72
First Posted: June 24, 2009    Key Record Dates
Last Update Posted: November 28, 2011
Last Verified: November 2011

Keywords provided by Central Institute of Mental Health, Mannheim:
Alcoholism
D-cycloserine
extinction
cue-exposure

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior
Cycloserine
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action