Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Hospital Universitari Vall d'Hebron Research Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT00437177
First received: February 16, 2007
Last updated: April 28, 2009
Last verified: April 2009
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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:
    Drug: apomorphine
    Apomorphine 0.05 mg/kg subcutaneously at hospital admission and at discharge. Abstinent participants at 3 months will receive a third dose.
    Drug: [(123)I] iodobenzamide
    [(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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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: m, Servei de Psiquiatria. Hospital Universitari Vall d'Hebron
ClinicalTrials.gov Identifier: NCT00437177     History of Changes
Other Study ID Numbers: OH SPECT APO, EudraCT: 2004-001893-24
Study First Received: February 16, 2007
Last Updated: April 28, 2009
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:
Alcoholism
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Apomorphine
Autonomic Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Agonists
Emetics
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014