NCT Number: NCT04777552
Fixed-schedule Benzodiazepine Dosing vs 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?
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
About this study
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).
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- patients who were treated for alcohol dependence at the UZ Brussel in one of the periods stated above.
Exclusion criteria
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,…
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Treatment and study plan
Primary outcomes
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total amount of benzodiazepines administrated
Time frame: 7 days
Sponsors and collaborators
Lead sponsor
Universitair Ziekenhuis Brussel
Other
Registry information
Official study title
The Use of Fixed-schedule Benzodiazepine Dosing Versus Treatment Based on a CIWA-Ar Alcohol Protocol in Alcohol Detoxification.
Important dates
- Study start
- 2015
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Mar 2, 2021
- Registry last updated
- Mar 2, 2021
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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