AlcoholismPhase 2ALC-DRD2-APONCT00437177
Relationship Between D2 Receptors SPECT and the Apomorphine Test in Patients With OH Dependence (ALC-DRD2-APO)
A Phase 2 study testing apomorphine and [(123)I] iodobenzamide in people with Alcoholism, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 60 years, men only
- Conditions the study is for
- Alcoholism
- What is being tested?
- apomorphine and [(123)I] iodobenzamide
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2007to Jun 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- alcohol dependence
- alcohol dependence length at least 8 years.
- male
- age 25 - 60 years
Who cannot join
- other drug dependence (except nicotine dependence)
- another major axis I psychiatric diagnosis
- comorbid neurological disorder
- comorbid cardiovascular disorder
- comorbid metabolic disorder
- brain injury
Show all 9Show fewer
- apomorphine allergy
- iode allergy
- diazepam allergy
Trial locations and contacts
1 site in 1 country.
Miquel Casas, Prof. contact
Xavier Castells, Prof contact
Spain1 site, 1 recruiting
- Recruiting
Psychiatry Service, Hospital Universitari Vall d'Hebron
Barcelona, Catalonia, 08036
Miquel Casas, Prof, mcasas@vhebron.net
Xavier Castells, xcc@icf.uab.cat
About this study
Official title: 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.
- Conditions
- Alcoholism
- Being tested
- apomorphine, [(123)I] iodobenzamide
- Keywords
- alcoholism, apomorphine, iodobenzamide, imaging, spect, relapse
- Medical subject headings
- Alcoholism, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apomorphineDrug
Apomorphine 0.05 mg/kg subcutaneously at hospital admission and at discharge. Abstinent participants at 3 months will receive a third dose.
[(123)I] iodobenzamideDrug
[(123)I] iodobenzamide 185 MBq I.V., at discharge.
What is being measured
The primary outcome is the main question the study is designed to answer.
To detertmine the agreement rate of the dopaminergic sensibility assessed by two different techiniques: the apomorphine test and and IBZM SPECT.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2007 (estimated)
- Study startJan 2007
- Primary completionDec 2009 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- Miquel Casas, Prof, Principal investigator, Psychiatry Service, Hospital Universitari Vall d'Hebron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00437177
- Sponsor's protocol ID
- OH SPECT APO
- Other IDs
- EudraCT: 2004-001893-24
- Acronym
- ALC-DRD2-APO
- Status last verified
- Apr 2009
- First submitted
- 16 Feb 2007
- Last updated
- 29 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between D2 Receptors SPECT and the Apomorphine Test in Patients With OH Dependence: Predictive Value for Relapse
- ClinicalTrials.gov ID
- NCT00437177
- Acronym / sponsor ID
- ALC-DRD2-APO / OH SPECT APO
- Conditions
- Alcoholism
- Keywords
- alcoholism, apomorphine, iodobenzamide, imaging, spect, relapse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 19 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- alcohol dependence
- alcohol dependence length at least 8 years.
- male
- age 25 - 60 years
Key exclusion criteria (9 listed)
- other drug dependence (except nicotine dependence)
- another major axis I psychiatric diagnosis
- comorbid neurological disorder
- comorbid cardiovascular disorder
- comorbid metabolic disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| apomorphineApomorphine 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. | Drug | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miquel Casas, Prof. contact
Xavier Castells, Prof contact
Miquel Casas, Prof principal investigator
Psychiatry Service, Hospital Universitari Vall d'Hebron
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing apomorphine and [(123)I] iodobenzamide in people with Alcoholism, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miquel Casas, Prof. (mcasas@vhebron.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2009.