Relationship Between D2 Receptors SPECT and the Apomorphi... | NCT00437177

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

NCT00437177

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Status

Unknown status

Last Update Posted

Apr 29, 2009Estimated

Enrollment

50Estimated

Phase

Phase 2

Conditions

Alcoholism

Interventions

apomorphine
[(123)I] iodobenzamide

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCT: 2004-001893-24

Status Module

Record Verification Date

Apr 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Dec 2009Estimated

Completion Date

Jun 2010Estimated

First Submitted Date

Feb 16, 2007

First Submission Date that Met QC Criteria

Feb 17, 2007

First Posted Date

Feb 19, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2009

Last Update Posted Date

Apr 29, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Hospital Universitari Vall d'Hebron Research InstituteOTHER

Collaborators

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
apomorphine	Drug	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	Drug	[(123)I] iodobenzamide 185 MBq I.V., at discharge.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To detertmine the agreement rate of the dopaminergic sensibility assessed by two different techiniques: the apomorphine test and and IBZM SPECT.		3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Miquel Casas, Prof.	Contact			mcasas@vhebron.net
Xavier Castells, Prof	Contact			xcc@icf.uab.cat

Overall Officials

Name	Affiliation	Role
Miquel Casas, Prof	Psychiatry Service, Hospital Universitari Vall d'Hebron	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Psychiatry Service, Hospital Universitari Vall d'Hebron	Recruiting	Barcelona	Catalonia	08036	Spain

Condition Browse Module

MeSH Terms

ID	Term
D000437	Alcoholism
D012008	Recurrence

Ancestor Terms

ID	Term
D019973	Alcohol-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001058	Apomorphine
C000614958	Iodine-123

Ancestor Terms

ID	Term
D001060	Aporphines
D044182	Benzylisoquinolines
D000470	Alkaloids
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided