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

Primary Purpose

Alcoholism

Status
Unknown status
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
apomorphine
[(123)I] iodobenzamide
Sponsored by
Hospital Universitari Vall d'Hebron Research Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alcoholism focused on measuring alcoholism, apomorphine, iodobenzamide, imaging, spect, relapse

Eligibility Criteria

25 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Psychiatry Service, Hospital Universitari Vall d'HebronRecruiting

Outcomes

Primary Outcome Measures

To detertmine the agreement rate of the dopaminergic sensibility assessed by two different techiniques: the apomorphine test and and IBZM SPECT.

Secondary Outcome Measures

Full Information

First Posted
February 16, 2007
Last Updated
April 28, 2009
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00437177
Brief Title
Relationship Between D2 Receptors SPECT and the Apomorphine Test in Patients With OH Dependence (ALC-DRD2-APO)
Acronym
ALC-DRD2-APO
Official Title
Relationship Between D2 Receptors SPECT and the Apomorphine Test in Patients With OH Dependence: Predictive Value for Relapse
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
June 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism
Keywords
alcoholism, apomorphine, iodobenzamide, imaging, spect, relapse

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
apomorphine
Intervention Description
Apomorphine 0.05 mg/kg subcutaneously at hospital admission and at discharge. Abstinent participants at 3 months will receive a third dose.
Intervention Type
Drug
Intervention Name(s)
[(123)I] iodobenzamide
Intervention Description
[(123)I] iodobenzamide 185 MBq I.V., at discharge.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miquel Casas, Prof.
Email
mcasas@vhebron.net
First Name & Middle Initial & Last Name or Official Title & Degree
Xavier Castells, Prof
Email
xcc@icf.uab.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miquel Casas, Prof
Organizational Affiliation
Psychiatry Service, Hospital Universitari Vall d'Hebron
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychiatry Service, Hospital Universitari Vall d'Hebron
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miquel Casas, Prof
Email
mcasas@vhebron.net
First Name & Middle Initial & Last Name & Degree
Xavier Castells
Email
xcc@icf.uab.cat
First Name & Middle Initial & Last Name & Degree
Miquel Casas, Prof

12. IPD Sharing Statement

Learn more about this trial

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

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