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

Alcoholism Clinical Trial

— ALC-DRD2-APO  

Official title:

Relationship Between D2 Receptors SPECT and the Apomorphine Test in Patients With OH Dependence: Predictive Value for Relapse

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00437177
• Other study ID #: OH SPECT APO
• Secondary ID: EudraCT: 2004-00
• Status: Recruiting
• Phase: Phase 2
• First received: February 16, 2007
• Last updated: April 28, 2009
• Start date: January 2007
• Est. completion date: June 2010

Study information

• Verified date: April 2009
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: Miquel Casas, Prof.
• Email: mcasas[@]vhebron.net
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 25 Years to 60 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Alcoholism

Intervention

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

Locations

Country	Name	City	State
Spain	Psychiatry Service, Hospital Universitari Vall d'Hebron	Barcelona	Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To detertmine the agreement rate of the dopaminergic sensibility assessed by two different techiniques: the apomorphine test and and IBZM SPECT.		3 months	No