The Role of the Glutamatergic System in the Extinction of Conditioned Reinforcement Processes (SFB636D6)
This study is currently recruiting participants.
Verified November 2011 by Central Institute of Mental Health, Mannheim
Sponsor:
Central Institute of Mental Health, Mannheim
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
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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
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 May 19, 2013