Alcohol Use DisorderNCT03276520
Randomized Diagnostic Trial Comparing Ethylglucuronide and Ethanol
A study testing ethyl glucuronide and ethanol in people with Alcohol Use Disorder, run by Hospital Clinic of Barcelona.
Trial summary
Background: Alcohol use disorders represent a major health burden. Efforts aiming at reducing alcohol-related harm include early detection of those with risky drinking habits as well detection of early relapse in patients with alcohol dependence who are detoxified and committed to abstinence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- ethyl glucuronide and ethanol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- No sites listed yet
- Study dates
- 14 Dec 2016to 31 Jul 2017
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects had to be diagnosed of alcohol dependence according to DSM-IV, they had to undergo regular urine screening as part of their treatment and be willing to give informed written consent.
Who cannot join
- conditions rendering patients unable to complete study procedures
About this study
Official title: Filling the Gap Between Lab and Clinical Impact: an Open Randomized Diagnostic Trial Comparing Urinary Ethylglucuronide and Ethanol in Alcohol Dependent Outpatients.
Background: Alcohol use disorders represent a major health burden. Efforts aiming at reducing alcohol-related harm include early detection of those with risky drinking habits as well detection of early relapse in patients with alcohol dependence who are detoxified and committed to abstinence. Recently, ethyl glucuronide has been proved to be a good biomarker for the detection of recent drinking. However, to date, no randomized diagnostic trial has tested its impact on drinking outcomes. The aim of this study was to assess, with a randomized design, the implications of ethyl glucuronide screening on alcohol outcomes, compared to screening with a low-sensitivity biomarker such as ethanol.
Methods: alcohol dependent outpatients were randomized to either 24 weeks of continuous screening with ethyl glucuronide or ethanol. Patients were aware of screening methods and results. After 24 weeks, all participants were screened with ethyl glucuronide. Self-reports were also gathered. A logistic regression model was performed comparing the rate of ethyl glucuronide positive results at study end between groups. Generalized estimating equations were performed to evaluate the descending rate of EtG positive patients in the EtG group, measured month to month.
- Conditions
- Alcohol Use Disorder
- Being tested
- ethyl glucuronide, ethanol
- Keywords
- ethyl glucuronide, biomarker, diagnostic randomized trial
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ethyl glucuronideDiagnostic test
alcohol urine screening with ethyl glucuronide
ethanolDiagnostic test
alcohol urine screening with ethanol
| Study group | Role | What they receive |
|---|---|---|
| ethyl glucuronide | Experimental | subjects being screened with ethyl glucuronide Receives: Diagnostic Test: ethyl glucuronide |
| ethanol | Active comparator | subjects being screened with ethanol Receives: Diagnostic Test: ethanol |
What is being measured
The primary outcome is the main question the study is designed to answer.
ethyl glucuronide positive rate
Percentage of patients screening positive to EtG at study end in each group
Measured: after six months of ongoing urine screening
descending of Etg positive rates in the Etg group
varying rate of EtG positive patinets in the intervention group during the study period
Measured: six months of ongoing urine screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start14 Dec 2016
- Primary completion1 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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 N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antoni Gual, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03276520
- Sponsor's protocol ID
- HCB/2015/0984
- Status last verified
- Sep 2017
- First submitted
- 7 Sep 2017
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Filling the Gap Between Lab and Clinical Impact: an Open Randomized Diagnostic Trial Comparing Urinary Ethylglucuronide and Ethanol in Alcohol Dependent Outpatients.
- ClinicalTrials.gov ID
- NCT03276520
- Acronym / sponsor ID
- HCB/2015/0984
- Conditions
- Alcohol Use Disorder
- Keywords
- ethyl glucuronide, biomarker, diagnostic randomized trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 14 Dec 2016 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 8 Sep 2017 (actual)
- 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.
Background: Alcohol use disorders represent a major health burden. Efforts aiming at reducing alcohol-related harm include early detection of those with risky drinking habits as well detection of early relapse in patients with alcohol dependence who are detoxified and committed to abstinence. Recently, ethyl glucuronide has been proved to be a good biomarker for the detection of recent drinking. However, to date, no randomized diagnostic trial has tested its impact on drinking outcomes. The aim of this study was to assess, with a randomized design, the implications of ethyl glucuronide screening on alcohol outcomes, compared to screening with a low-sensitivity biomarker such as ethanol.
Methods: alcohol dependent outpatients were randomized to either 24 weeks of continuous screening with ethyl glucuronide or ethanol. Patients were aware of screening methods and results. After 24 weeks, all participants were screened with ethyl glucuronide. Self-reports were also gathered. A logistic regression model was performed comparing the rate of ethyl glucuronide positive results at study end between groups. Generalized estimating equations were performed to evaluate the descending rate of EtG positive patients in the EtG group, measured month to month.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ethyl glucuronide | Experimental | Diagnostic Test: ethyl glucuronidesubjects being screened with ethyl glucuronide |
| ethanol | Active comparator | Diagnostic Test: ethanolsubjects being screened with ethanol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- subjects had to be diagnosed of alcohol dependence according to DSM-IV, they had to undergo regular urine screening as part of their treatment and be willing to give informed written consent.
Key exclusion criteria (1 listed)
- conditions rendering patients unable to complete study procedures
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 |
|---|---|---|
| ethyl glucuronidealcohol urine screening with ethyl glucuronide | Diagnostic test | ethyl glucuronide |
| ethanolalcohol urine screening with ethanol | Diagnostic test | ethanol |
Primary outcome
ethyl glucuronide positive rate
Time frame: after six months of ongoing urine screening
Percentage of patients screening positive to EtG at study end in each group
descending of Etg positive rates in the Etg group
Time frame: six months of ongoing urine screening
varying rate of EtG positive patinets in the intervention group during the study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ethyl glucuronide and ethanol in people with Alcohol Use Disorder, run by Hospital Clinic of Barcelona.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ethyl glucuronide positive rate (time frame: after six months of ongoing urine screening). The study lists 2 primary outcomes in all. 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 11 Sep 2017.