Clinical trial NCT04777552: Fixed-schedule Benzodiazepine Dosing vs Based on a CIWA-Ar Alcohol Protocol in Alcohol Detoxification.
Official title: The Use of Fixed-schedule Benzodiazepine Dosing Versus Treatment Based on a CIWA-Ar Alcohol Protocol in Alcohol Detoxification.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcoholdependence
CIWA-R
Benzodiazepines
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2021-03-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who were treated for alcohol dependence at the UZ Brussel in one of the periods stated above.

Brief 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 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).

Eligibility criteria: 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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Primary outcomes:
measure: total amount of benzodiazepines administrated
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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