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Relationship Between D2 Receptors SPECT and the Apomorphine Test in Patients With OH Dependence (ALC-DRD2-APO) (ALC-DRD2-APO)

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ClinicalTrials.gov Identifier: NCT00437177
Recruitment Status : Unknown
Verified April 2009 by Hospital Universitari Vall d'Hebron Research Institute.
Recruitment status was:  Recruiting
First Posted : February 19, 2007
Last Update Posted : April 29, 2009
Sponsor:
Information provided by:
Hospital Universitari Vall d'Hebron Research Institute

Brief Summary:
OH dependence is associated with DA receptor changes. Both, the apomorphine test and the D2Rec SPECt are usefull for monitoring DA receptor status. We aimed at studying whether DA receptor hypofunction, assessed by means of the apomorphine test and the D2Rec SPECT, is a marker of relapse in detoxified OH dependents patients.

Condition or disease Intervention/treatment Phase
Alcoholism Drug: apomorphine Drug: [(123)I] iodobenzamide Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Relationship Between D2 Receptors SPECT and the Apomorphine Test in Patients With OH Dependence: Predictive Value for Relapse
Study Start Date : January 2007
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : June 2010

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Intervention Details:
  • Drug: apomorphine
    Apomorphine 0.05 mg/kg subcutaneously at hospital admission and at discharge. Abstinent participants at 3 months will receive a third dose.
  • Drug: [(123)I] iodobenzamide
    [(123)I] iodobenzamide 185 MBq I.V., at discharge.


Primary Outcome Measures :
  1. To detertmine the agreement rate of the dopaminergic sensibility assessed by two different techiniques: the apomorphine test and and IBZM SPECT. [ Time Frame: 3 months ]


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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • alcohol dependence
  • alcohol dependence length at least 8 years.
  • male
  • age 25 - 60 years

Exclusion Criteria:

  • other drug dependence (except nicotine dependence)
  • another major axis I psychiatric diagnosis
  • comorbid neurological disorder
  • comorbid cardiovascular disorder
  • comorbid metabolic disorder
  • brain injury
  • apomorphine allergy
  • iode allergy
  • diazepam allergy

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00437177


Contacts
Contact: Miquel Casas, Prof. mcasas@vhebron.net
Contact: Xavier Castells, Prof xcc@icf.uab.cat

Locations
Spain
Psychiatry Service, Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Catalonia, Spain, 08036
Contact: Miquel Casas, Prof       mcasas@vhebron.net   
Contact: Xavier Castells       xcc@icf.uab.cat   
Principal Investigator: Miquel Casas, Prof         
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Investigators
Principal Investigator: Miquel Casas, Prof Psychiatry Service, Hospital Universitari Vall d'Hebron

Responsible Party: m, Servei de Psiquiatria. Hospital Universitari Vall d'Hebron
ClinicalTrials.gov Identifier: NCT00437177     History of Changes
Other Study ID Numbers: OH SPECT APO
EudraCT: 2004-001893-24
First Posted: February 19, 2007    Key Record Dates
Last Update Posted: April 29, 2009
Last Verified: April 2009

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
alcoholism
apomorphine
iodobenzamide
imaging
spect
relapse

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Apomorphine
Emetics
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action