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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Central Institute of Mental Health, Mannheim.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Central Institute of Mental Health, Mannheim
ClinicalTrials.gov Identifier:
NCT00926900
First received: June 22, 2009
Last updated: November 24, 2011
Last verified: November 2011
  Purpose

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 Intervention Phase
Alcohol Drinking
Drug: D-cycloserine
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Role of the Glutamatergic System in the Extinction of Conditioned Reinforcement Processes

Resource links provided by NLM:


Further study details as provided by Central Institute of Mental Health, Mannheim:

Primary Outcome Measures:
  • reduction in cue-reactivity to alcohol-associated stimuli assessed by functional magnetic resonance imaging [ Time Frame: following completion of cue-exposure therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • time to first severe relapse to alcohol consumption [ Time Frame: at 3 and 6 months after treatment completion ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: March 2009
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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 -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided by Central Institute of Mental Health, Mannheim

Additional 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
Study First Received: June 22, 2009
Last Updated: November 24, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Therapeutic Uses
Pharmacologic Actions
Renal Agents
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014