Alcohol DrinkingOBADENCT02835365
Observational Study on Patients With Baclofen Treatment for Alcohol-dependence in France
An observational study of Alcohol Drinking and Cirrhosis, run by Centre Hospitalier Intercommunal Creteil at 8 sites in France.
Trial summary
Baclofen is an agonist of the amino-butyricum B (GABA-B) receptor used for a long time in neurology to treat spastic contracture. Several clinical studies have suggested its efficacy in the treatment of alcohol-dependence in low, even in case of cirrhosis and high dose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Drinking, Cirrhosis, Alcohol Withdrawal
- How many people
- 218 participants
- Where
- 8 sitesFrance
- Study dates
- 1 Jan 2015to Sep 2018
- Phase
- Observational
- 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
Study population: Any patients older than 18 years old and who received a baclofen therapy for alcohol-dependance after 2012 in a participating site is eligible. The referral physician must inform the patient. Only patients who give their oralm accceptance will be included.
Who may be able to join
- patients older than 18 years old
- patient treated with baclofen therapy after 2012 for alcoholo-dependance
Who cannot join
- Baclofen therapy before 2012
- patient who refuse to participate
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Centre Hospitalier Régional Universitaire Hôpital Jean Minjoz
Besançon, Franche-Comté, 25030
CH Béziers
Béziers, Hérault, 34525
GHPSO Creil-Senlis
Creil, Oise, 60109
CHI CRETEIL addictology
Créteil, 94000
CH meaux
Meaux, Seine Et Marne, 77100
CH Orleans
Orléans, Loiret, 45067
Centre hospitalier yves LEFOLL
Saint-Brieuc, Côtes d'Armor, 22023
Hôpital saint denis
Saint-Denis, Île-de-France Region, 93205
About this study
Official title: Observational Study on Patients With Baclofen Treatment for Alcohol-dependence in French Gastro and Hepatology Departments
Baclofen is an agonist of the amino-butyricum B (GABA-B) receptor used for a long time in neurology to treat spastic contracture. Several clinical studies have suggested its efficacy in the treatment of alcohol-dependence in low, even in case of cirrhosis and high dose. French drug authority has authorized its use in 2012 whereas the l'European Association for the Study of the Liver recommends to perform additional studies on this indication.
The goal of this observational study is to evaluate the use of baclofen for alcohol-dependence in real life care as well its efficacy.
Read the detailed description
Numerous centers of the French research group of the national association of the hepatologists and gastroenterologists from general hospitals (ANGH) will be part of this study. Patients treated with baclofen for alcohol -dependence will be enroll prospectively from 2014 and retrospectively if they were treated between 2012 and 2014. The reported alcohol consumption, biological markers of excessive alcohol, initial and usual baclofen dosage, blood balofen dosage as well as clinical data will be collected.
- Conditions
- Alcohol Drinking, Cirrhosis, Alcohol Withdrawal
- Keywords
- baclofen, alcohol, withdrawal
- Medical subject headings
- Alcohol Drinking, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients treated with baclofen | Patients treated with baclofen to diminish their alcohol consumption in the ANGH centers will be enrolled |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target population
Demographic and clinical characteristics of patients who take baclofen for alcohol addiction: mean age, alcohol consumption, child pugh score, etc.
Measured: at inclusion
Secondary outcomes (5)
baclofen posology
used baclofen posology will be recorded to determine the posology scheme to treat patients with or without cirrhosis
Measured: at inclusion, at 3, 6 and 12 months of follow-up
Alcohol consumption
Evolution of the alcohol consumption in patients under baclofen therapy
Measured: at inclusion, at 3, 6 and 12 months of follow-up
Biological markers of alcohol consumption
Evolution of the biological markers of alcohol consumption in patients under baclofen therapy
Measured: at inclusion, at 3, 6 and 12 months of follow-up
baclofen tolerance
Description of the side effects under baclofen therapy
Measured: at 3, 6 and 12 months of follow-up
Baclofen dosage
Blood baclofen dosage under baclofen treatment, if available
Measured: at 3, 6 and 12 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study start1 Jan 2015
- Primary completionAug 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Camille Barrault, Centre Hospitalier Intercommunal Creteil
- Investigators
- Camille barrault, MD, Principal investigator, CHI Créteil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835365
- Sponsor's protocol ID
- OBADE
- Acronym
- OBADE
- Status last verified
- Jan 2023
- First submitted
- 11 Jul 2016
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on Patients With Baclofen Treatment for Alcohol-dependence in French Gastro and Hepatology Departments
- ClinicalTrials.gov ID
- NCT02835365
- Acronym / sponsor ID
- OBADE / OBADE
- Conditions
- Alcohol Drinking, Cirrhosis, Alcohol Withdrawal
- Keywords
- baclofen, alcohol, withdrawal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 18 Jul 2016 (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.
Baclofen is an agonist of the amino-butyricum B (GABA-B) receptor used for a long time in neurology to treat spastic contracture. Several clinical studies have suggested its efficacy in the treatment of alcohol-dependence in low, even in case of cirrhosis and high dose. French drug authority has authorized its use in 2012 whereas the l'European Association for the Study of the Liver recommends to perform additional studies on this indication.
The goal of this observational study is to evaluate the use of baclofen for alcohol-dependence in real life care as well its efficacy.
Detailed description
Numerous centers of the French research group of the national association of the hepatologists and gastroenterologists from general hospitals (ANGH) will be part of this study. Patients treated with baclofen for alcohol -dependence will be enroll prospectively from 2014 and retrospectively if they were treated between 2012 and 2014. The reported alcohol consumption, biological markers of excessive alcohol, initial and usual baclofen dosage, blood balofen dosage as well as clinical data will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients treated with baclofen | – | –Patients treated with baclofen to diminish their alcohol consumption in the ANGH centers will be enrolled |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patients older than 18 years old and who received a baclofen therapy for alcohol-dependance after 2012 in a participating site is eligible. The referral physician must inform the patient. Only patients who give their oralm accceptance will be included.
Key inclusion criteria (2 listed)
- patients older than 18 years old
- patient treated with baclofen therapy after 2012 for alcoholo-dependance
Key exclusion criteria (2 listed)
- Baclofen therapy before 2012
- patient who refuse to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Target population
Time frame: at inclusion
Demographic and clinical characteristics of patients who take baclofen for alcohol addiction: mean age, alcohol consumption, child pugh score, etc.
5 secondary outcomes
baclofen posology
Time frame: at inclusion, at 3, 6 and 12 months of follow-up
Alcohol consumption
Time frame: at inclusion, at 3, 6 and 12 months of follow-up
Biological markers of alcohol consumption
Time frame: at inclusion, at 3, 6 and 12 months of follow-up
baclofen tolerance
Time frame: at 3, 6 and 12 months of follow-up
Baclofen dosage
Time frame: at 3, 6 and 12 months of follow-up
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 12 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Camille barrault, MD principal investigator
CHI Créteil
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Drinking and Cirrhosis, run by Centre Hospitalier Intercommunal Creteil at 8 sites in France.
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 2 inclusion and 2 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 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. 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.
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?
Target population (time frame: at inclusion). 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 12 Jan 2023.