NCT00926900

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Last Updated

November 28, 2011

Status Verified

November 1, 2011

Enrollment Period

3.1 years

First QC Date

June 22, 2009

Last Update Submit

November 24, 2011

Conditions

Alcohol Drinking

Keywords

AlcoholismD-cycloserineextinctioncue-exposure

Outcome Measures

Primary Outcomes (1)

  • reduction in cue-reactivity to alcohol-associated stimuli assessed by functional magnetic resonance imaging

    following completion of cue-exposure therapy

Secondary Outcomes (1)

  • time to first severe relapse to alcohol consumption

    at 3 and 6 months after treatment completion

Study Arms (2)

D-cycloserine

ACTIVE COMPARATOR
Drug: D-cycloserine

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

D-cycloserineDRUG

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

D-cycloserine
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Institute of Mental Health

Mannheim, 68159, Germany

RECRUITING

Related Publications (2)

  • 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.

    PMID: 31908107DERIVED

  • 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.

    PMID: 21292243DERIVED

MeSH Terms

Conditions

Alcohol DrinkingAlcoholism

Interventions

Cycloserine

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

IsoxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsOxazolidinonesOxazolesSerineAmino Acids, NeutralAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Falk Kiefer, Professor

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Falk Kiefer, Professor

CONTACT

+49 621 1703 3522falk.kiefer@zi-mannheim.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2009

First Posted

June 24, 2009

Study Start

March 1, 2009

Primary Completion

April 1, 2012

Last Updated

November 28, 2011

Record last verified: 2011-11

Locations

DE(1)