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

November 24, 2011 updated by: Central Institute of Mental Health, Mannheim

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Mannheim, Germany, 68159
        • Recruiting
        • Central Institute of Mental Health
        • Contact:
        • Principal Investigator:
          • Falk Kiefer, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
reduction in cue-reactivity to alcohol-associated stimuli assessed by functional magnetic resonance imaging
Time Frame: following completion of cue-exposure therapy
following completion of cue-exposure therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
time to first severe relapse to alcohol consumption
Time Frame: at 3 and 6 months after treatment completion
at 3 and 6 months after treatment completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Institute of Mental Health, Mannheim

Collaborators

German Research Foundation

Investigators

  • Principal Investigator: Falk Kiefer, Professor, Central Institute of Mental Health, Department of Addictive Behavior and Addiction Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Anticipated)

April 1, 2012

Study Registration Dates

First Submitted

June 22, 2009

First Submitted That Met QC Criteria

June 23, 2009

First Posted (Estimate)

June 24, 2009

Study Record Updates

Last Update Posted (Estimate)

November 28, 2011

Last Update Submitted That Met QC Criteria

November 24, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SFB636 D6 2006-007090-72

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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