The Role of the Glutamatergic System in the Extinction of Conditioned Reinforcement Processes

NCT ID: NCT00926900

Last Updated: 2011-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alcohol Drinking

Keywords

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Alcoholism D-cycloserine extinction cue-exposure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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D-cycloserine

Group Type ACTIVE_COMPARATOR

D-cycloserine

Intervention Type DRUG

50 mg at approximately 1.5 hours prior to cue-exposure training sessions

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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D-cycloserine

50 mg at approximately 1.5 hours prior to cue-exposure training sessions

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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 -
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Research Foundation

OTHER

Sponsor Role collaborator

Central Institute of Mental Health, Mannheim

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Falk Kiefer, Professor

Role: PRINCIPAL_INVESTIGATOR

Central Institute of Mental Health, Department of Addictive Behavior and Addiction Medicine

Locations

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Central Institute of Mental Health

Mannheim, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Falk Kiefer, Professor

Role: CONTACT

Phone: +49 621 1703 3522

Email: [email protected]

Facility Contacts

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Falk Kiefer, Professor

Role: primary

References

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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.

Reference Type DERIVED
PMID: 31908107 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21292243 (View on PubMed)

Other Identifiers

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SFB636 D6 2006-007090-72

Identifier Type: -

Identifier Source: org_study_id