NCT04777552

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?

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
4.8 years until next milestone

First Posted

Study publicly available on registry

March 2, 2021

Completed
Last Updated

March 2, 2021

Status Verified

February 1, 2021

Enrollment Period

6 months

First QC Date

December 9, 2015

Last Update Submit

February 25, 2021

Conditions

AlcoholdependenceCIWA-RBenzodiazepines

Outcome Measures

Primary Outcomes (1)

  • total amount of benzodiazepines administrated

    7 days

Study Arms (2)

Fixed-schedule

Untill mid 2013 patients with individually determined fixed-schedule dosage of benzodiazepines in the case of alcoholdependence.

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.

Other: diazepam (or equivalence if other benzodiazepine)

Interventions

diazepam (or equivalence if other benzodiazepine)OTHER
CIWA-ArFixed-schedule

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients who were treated for alcohol dependence at the UZ Brussel in one of the periods stated above.

You may qualify if:

  • patients who were treated for alcohol dependence at the UZ Brussel in one of the periods stated above.

You may not qualify if:

  • 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,…

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Diazepam

Intervention Hierarchy (Ancestors)

BenzodiazepinonesBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD Resident Psychiatry

Study Record Dates

First Submitted

December 9, 2015

First Posted

March 2, 2021

Study Start

October 1, 2015

Primary Completion

April 1, 2016

Study Completion

May 1, 2016

Last Updated

March 2, 2021

Record last verified: 2021-02