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

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00437177
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Duration (Months): 41
• Patients Per Site Per Month: 1.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Alcoholism	Drug: apomorphine; Drug: [(123)I] iodobenzamide	Phase 2

Study Design

• Study Type: Interventional
• Anticipated 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: Jan 1, 2007
• Anticipated Primary Completion Date: Dec 1, 2009
• Anticipated Study Completion Date: Jun 1, 2010

Outcome Measures

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. [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 60 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Psychiatry Service, Hospital Universitari Vall d'Hebron	Barcelona	Catalonia	Spain	08036

Sponsors and Collaborators

• Hospital Universitari Vall d'Hebron Research Institute

Investigators

• Principal Investigator: Miquel Casas, Prof, Psychiatry Service, Hospital Universitari Vall d'Hebron

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00437177
• Other Study ID Numbers: OH SPECT APO; EudraCT: 2004-001893-24
• First Posted: Feb 19, 2007
• Last Update Posted: Apr 29, 2009
• Last Verified: Apr 1, 2009

• Keywords provided by , ,: alcoholism; apomorphine; iodobenzamide; imaging; spect; relapse
• Additional relevant MeSH terms: Alcoholism; Apomorphine

Study Results

No Results Posted as of Apr 29, 2009