AlcoholdependenceNCT04777552
Fixed-schedule Benzodiazepine Dosing vs Based on a CIWA-Ar Alcohol Protocol in Alcohol Detoxification.
An observational study of Alcoholdependence and CIWA-R, run by Universitair Ziekenhuis Brussel.
Trial summary
Does the use of a symptom-triggered therapy (with assessment making use of a CIWA-Ar scale) decrease the total amount of benzodiazepines given to patients with alcohol dependence and are less patients still dependent on benzodiazepines on their departure in comparison with the use of a fixed-schedule dose of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcoholdependence, CIWA-R, Benzodiazepines
- What is being tested?
- diazepam (or equivalence if other benzodiazepine)
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to May 2016
- 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: patients who were treated for alcohol dependence at the UZ Brussel in one of the periods stated above.
Who may be able to join
- patients who were treated for alcohol dependence at the UZ Brussel in one of the periods stated above.
Who cannot join
- pregnancy, use of central nervous system (CNS) depressant agents, history of dementia, acute psychosis, and severe hepatic dysfunction. Comorbid benzodiazepine dependence. A history of severe epilepsy on withdrawal,…
- -
About this study
Official title: The Use of Fixed-schedule Benzodiazepine Dosing Versus Treatment Based on a CIWA-Ar Alcohol Protocol in Alcohol Detoxification.
Does the use of a symptom-triggered therapy (with assessment making use of a CIWA-Ar scale) decrease the total amount of benzodiazepines given to patients with alcohol dependence and are less patients still dependent on benzodiazepines on their departure in comparison with the use of a fixed-schedule dose of benzodiazepines?
Read the detailed description
Methodology This study will be a retrospective study using administrative and clinical patient data of patients presenting for alcohol detoxification at the Psychiatry department of the Universitair Ziekenhuis Brussel. Two periods in the data will be compared. One period will be consisting of patient data before 2013 when the hospital still used the fixed-schedule dosing of benzodiazepines. The other period will be consisting of patient data after 2013 when the hospital switched to the symptom-triggered prescription of benzodiazepines.
Inclusion \& Exclusion criteria Inclusion criteria are patients with the age of 18 years or older who were treated for alcohol .dependence at the UZ Brussel in one of the periods stated above. The criteria for exclusion were found in the literature and include pregnancy, use of central nervous system (CNS) depressant agents, history of dementia, acute psychosis, and severe hepatic dysfunction (15-18). Comorbid benzodiazepine dependence. A history of severe epilepsy on withdrawal,… Outcomes The main outcome measures will be the total amount of benzodiazepines given during the hospital stay, whether the patient is still dependent on benzodiazepines when leaving the hospital, the length of the hospital stay, and some baseline patient characteristics. These patient characteristics will include age, sex, race/ethnic group, primary reason for hospitalization, body mass index (BMI), blood alcohol level (BAL) on admission, international normalized ratio (INR), diagnosis of co-morbid psychiatric disorder, history of other substance abuse, indicators of withdrawal severity (e.g. CIWA-Ar, tremor, seizures), discharge medications, benzodiazepine dose administered (15-18).
- Conditions
- Alcoholdependence, CIWA-R, Benzodiazepines
- Being tested
- diazepam (or equivalence if other benzodiazepine)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diazepam (or equivalence if other benzodiazepine)Other
| Study group | Role | What they receive |
|---|---|---|
| Fixed-schedule | Untill mid 2013 patients with individually determined fixed-schedule dosage of benzodiazepines in the case of alcoholdependence. Receives: Other: diazepam (or equivalence if other benzodiazepine) | |
| CIWA-Ar | Halfway through the year 2013 the department of psychiatry changed the protocol in alcohol withdrawal treatment and changed it to a symptom-triggered therapy with the use of CIWA-Ar to assess the severity of the alcohol withdrawal syndrome. Receives: Other: diazepam (or equivalence if other benzodiazepine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
total amount of benzodiazepines administrated
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study startOct 2015
- Primary completionApr 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlcoholdependenceStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dieter Zeeuws, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777552
- Sponsor's protocol ID
- 2015/298
- Status last verified
- Feb 2021
- First submitted
- 9 Dec 2015
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Fixed-schedule Benzodiazepine Dosing Versus Treatment Based on a CIWA-Ar Alcohol Protocol in Alcohol Detoxification.
- ClinicalTrials.gov ID
- NCT04777552
- Acronym / sponsor ID
- 2015/298
- Conditions
- Alcoholdependence, CIWA-R, Benzodiazepines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 2 Mar 2021 (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.
Does the use of a symptom-triggered therapy (with assessment making use of a CIWA-Ar scale) decrease the total amount of benzodiazepines given to patients with alcohol dependence and are less patients still dependent on benzodiazepines on their departure in comparison with the use of a fixed-schedule dose of benzodiazepines?
Detailed description
Methodology This study will be a retrospective study using administrative and clinical patient data of patients presenting for alcohol detoxification at the Psychiatry department of the Universitair Ziekenhuis Brussel. Two periods in the data will be compared. One period will be consisting of patient data before 2013 when the hospital still used the fixed-schedule dosing of benzodiazepines. The other period will be consisting of patient data after 2013 when the hospital switched to the symptom-triggered prescription of benzodiazepines.
Inclusion \& Exclusion criteria Inclusion criteria are patients with the age of 18 years or older who were treated for alcohol .dependence at the UZ Brussel in one of the periods stated above. The criteria for exclusion were found in the literature and include pregnancy, use of central nervous system (CNS) depressant agents, history of dementia, acute psychosis, and severe hepatic dysfunction (15-18). Comorbid benzodiazepine dependence. A history of severe epilepsy on withdrawal,… Outcomes The main outcome measures will be the total amount of benzodiazepines given during the hospital stay, whether the patient is still dependent on benzodiazepines when leaving the hospital, the length of the hospital stay, and some baseline patient characteristics. These patient characteristics will include age, sex, race/ethnic group, primary reason for hospitalization, body mass index (BMI), blood alcohol level (BAL) on admission, international normalized ratio (INR), diagnosis of co-morbid psychiatric disorder, history of other substance abuse, indicators of withdrawal severity (e.g. CIWA-Ar, tremor, seizures), discharge medications, benzodiazepine dose administered (15-18).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fixed-schedule | – | Other: diazepam (or equivalence if other benzodiazepine)Untill mid 2013 patients with individually determined fixed-schedule dosage of benzodiazepines in the case of alcoholdependence. |
| CIWA-Ar | – | Other: diazepam (or equivalence if other benzodiazepine)Halfway through the year 2013 the department of psychiatry changed the protocol in alcohol withdrawal treatment and changed it to a symptom-triggered therapy with the use of CIWA-Ar to assess the severity of the alcohol withdrawal syndrome. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who were treated for alcohol dependence at the UZ Brussel in one of the periods stated above.
Key inclusion criteria (1 listed)
- patients who were treated for alcohol dependence at the UZ Brussel in one of the periods stated above.
Key exclusion criteria (2 listed)
- pregnancy, use of central nervous system (CNS) depressant agents, history of dementia, acute psychosis, and severe hepatic dysfunction. Comorbid benzodiazepine dependence. A history of severe epilepsy on withdrawal,…
- -
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 |
|---|---|---|
| diazepam (or equivalence if other benzodiazepine) | Other | CIWA-Ar, Fixed-schedule |
Primary outcome
total amount of benzodiazepines administrated
Time frame: 7 days
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 2 Mar 2021.
- Individual participant dataSharing planned: Undecided
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?
An observational study of Alcoholdependence and CIWA-R, run by Universitair Ziekenhuis Brussel.
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 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 2 Mar 2021. 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?
total amount of benzodiazepines administrated (time frame: 7 days). 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 2 Mar 2021.