- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00437177
Relationship Between D2 Receptors SPECT and the Apomorphine Test in Patients With OH Dependence (ALC-DRD2-APO) (ALC-DRD2-APO)
April 28, 2009 updated by: Hospital Universitari Vall d'Hebron Research Institute
Relationship Between D2 Receptors SPECT and the Apomorphine Test in Patients With OH Dependence: Predictive Value for Relapse
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Catalonia
-
Barcelona, Catalonia, Spain, 08036
- Recruiting
- Psychiatry Service, Hospital Universitari Vall d'Hebron
-
Contact:
- Miquel Casas, Prof
- Email: mcasas@vhebron.net
-
Contact:
- Xavier Castells
- Email: xcc@icf.uab.cat
-
Principal Investigator:
- Miquel Casas, Prof
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Miquel Casas, Prof, Psychiatry Service, Hospital Universitari Vall d'Hebron
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (ANTICIPATED)
December 1, 2009
Study Completion (ANTICIPATED)
June 1, 2010
Study Registration Dates
First Submitted
February 16, 2007
First Submitted That Met QC Criteria
February 17, 2007
First Posted (ESTIMATE)
February 19, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
April 29, 2009
Last Update Submitted That Met QC Criteria
April 28, 2009
Last Verified
April 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Alcohol-Related Disorders
- Substance-Related Disorders
- Alcoholism
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Gastrointestinal Agents
- Dopamine Agonists
- Dopamine Agents
- Emetics
- Apomorphine
Other Study ID Numbers
- OH SPECT APO
- EudraCT: 2004-001893-24
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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