NCT00437177

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2007

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 19, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

April 29, 2009

Status Verified

April 1, 2009

Enrollment Period

2.9 years

First QC Date

February 16, 2007

Last Update Submit

April 28, 2009

Conditions

Keywords

alcoholismapomorphineiodobenzamideimagingspectrelapse

Outcome Measures

Primary Outcomes (1)

  • To detertmine the agreement rate of the dopaminergic sensibility assessed by two different techiniques: the apomorphine test and and IBZM SPECT.

    3 months

Interventions

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 Criteria

Age25 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • alcohol dependence
  • alcohol dependence length at least 8 years.
  • male
  • age 25 - 60 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatry Service, Hospital Universitari Vall d'Hebron

Barcelona, Catalonia, 08036, Spain

RECRUITING

MeSH Terms

Conditions

AlcoholismRecurrence

Interventions

ApomorphineIodine-123

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AporphinesBenzylisoquinolinesAlkaloidsHeterocyclic CompoundsIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 4 or More Rings

Study Officials

  • Miquel Casas, Prof

    Psychiatry Service, Hospital Universitari Vall d'Hebron

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Miquel Casas, Prof.

CONTACT

Xavier Castells, Prof

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 16, 2007

First Posted

February 19, 2007

Study Start

January 1, 2007

Primary Completion

December 1, 2009

Study Completion

June 1, 2010

Last Updated

April 29, 2009

Record last verified: 2009-04

Locations