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

This study is currently recruiting participants.

Verified by Hospital Universitari Vall d'Hebron Research Institute, April 2009

First Received: February 16, 2007 Last Updated: April 28, 2009 History of Changes

Sponsor:	Hospital Universitari Vall d'Hebron Research Institute
Information provided by:	Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:	NCT00437177

Purpose

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	Intervention	Phase
Alcoholism	Drug: apomorphine Drug: [(123)I] iodobenzamide	Phase II

Study Type:	Interventional
Study Design:	Basic Science, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Relationship Between D2 Receptors SPECT and the Apomorphine Test in Patients With OH Dependence: Predictive Value for Relapse

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism

Drug Information available for: Apomorphine Apomorphine hydrochloride

U.S. FDA Resources

Further study details as provided by Hospital Universitari Vall d'Hebron Research Institute:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	January 2007
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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 185 MBq I.V., at discharge.

Eligibility

Ages Eligible for Study:	25 Years to 60 Years
Genders 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00437177

Contacts

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

Locations

Spain, Catalonia
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

More Information

No publications provided

Responsible Party:	Servei de Psiquiatria. Hospital Universitari Vall d'Hebron ( m )
Study ID Numbers:	OH SPECT APO, EudraCT: 2004-001893-24
Study First Received:	February 16, 2007
Last Updated:	April 28, 2009
ClinicalTrials.gov Identifier:	NCT00437177 History of Changes
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:

alcoholism
apomorphine
iodobenzamide

imaging
spect
relapse

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Disorders of Environmental Origin
Antiparkinson Agents
Dopamine Agonists
Apomorphine

Pharmacologic Actions
Mental Disorders
Therapeutic Uses
Alcoholism
Substance-Related Disorders
Alcohol-Related Disorders
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010