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Baclofen in Managing Acute Alcohol Withdrawal

Primary Purpose

Alcohol Use Disorder, Alcohol Withdrawal

Status

Unknown status

Phase

Phase 4

Locations

Belgium

Study Type

Interventional

Intervention

Diazepam 10 MG

Baclofen 30mg

Baclofen 60mg

About this trial

This is an interventional treatment trial for Alcohol Use Disorder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Be an inpatient at the Psychiatry unit at UZBrussel at time of study enrollment.
Be able to sign informed consent.
Be male/female aged 18-60
Primary diagnosis of alcohol use disorder.

Exclusion Criteria:

Pregnancy and breastfeeding.
Benzodiazepine use of more than the equivalent of diazepam 25 mg /day.
Psychosis, confusion and acute mania.
Parkinson's disease.
Use of tricyclic antidepressants.
Use of opioids.
Known baclofen or benzodiazepine sensitivity or allergy.
Unable to take oral medication.
epidermal growth factor receptor (EGFR) < 60 (blood samples are routinely performed at intake).
Prior diagnosis of epilepsy.
Lactose intolerance.

Sites / Locations

University Hospital BrusselsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Baclofen 30 mg/day

Baclofen 60 mg/day

Placebo

Arm Description

baclofen 30 mg/day

Outcomes

Primary Outcome Measures

Need for additional diazepam

Amount of patients who lack the need of additional diazepam during 7-day alcohol withdrawal

Secondary Outcome Measures

Dosage of additional diazepam needed

The difference between the total dosages of additional diazepam needed between the three study arms

Full Information

NCT ID

NCT03293017

First Posted

June 19, 2017

Last Updated

November 3, 2021

Sponsor

Universitair Ziekenhuis Brussel

1. Study Identification

Unique Protocol Identification Number

NCT03293017

Brief Title

Baclofen in Managing Acute Alcohol Withdrawal

Official Title

Baclofen Bij de Behandeling Van Acute Alcoholontwenning

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Unknown status

Study Start Date

February 1, 2016 (Actual)

Primary Completion Date

February 1, 2022 (Anticipated)

Study Completion Date

February 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universitair Ziekenhuis Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The study goal is to investigate whether administration of oral baclofen forms an adequate treatment option in the management of acute alcohol withdrawal. The investigators will compare placebo with doses of baclofen 30 and 60 milligram per day (mg/day) in a randomized controlled trial including patients receiving symptom triggered diazepam.

Detailed Description

The conducted study will be randomized and single-blind (patients). After signing informed consent, the participants will be randomized in one of three groups: - placebo - baclofen 30 mg/day - baclofen 60 mg/day. The participants will be given a first administration after which the participant can receive Clinical Institute Withdrawal Assessment (CIWA-ar) score triggered diazepam, frequently assessed for at least 7 days. The primary outcome measure is the number of participants who received additional diazepam during these 7 days. The secondary outcome measure is the amount of diazepam received per group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Use Disorder, Alcohol Withdrawal

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Baclofen 30 mg/day

Arm Type

Experimental

Arm Description

baclofen 30 mg/day

Arm Title

Baclofen 60 mg/day

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Diazepam 10 MG

Intervention Description

If a patient's linical Institute Withdrawal Assessment (CIWA-ar) is more than 15 and did not decrease with 4 points compared to the previous score, they will be given oral diazepam to supress their symptoms, in a tablet of 10 mg.

Intervention Type

Drug

Intervention Name(s)

Baclofen 30mg

Intervention Description

Baclofen 30 mg/day given over three gifts daily

Intervention Type

Drug

Intervention Name(s)

Baclofen 60mg

Intervention Description

Baclofen 60 mg/day given over three gifts daily

Primary Outcome Measure Information:

Title

Need for additional diazepam

Description

Amount of patients who lack the need of additional diazepam during 7-day alcohol withdrawal

Time Frame

Measured 7 days after the start of alcohol withdrawal

Secondary Outcome Measure Information:

Title

Dosage of additional diazepam needed

Description

The difference between the total dosages of additional diazepam needed between the three study arms

Time Frame

Measured 7 days after the start of alcohol withdrawal

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Be an inpatient at the Psychiatry unit at UZBrussel at time of study enrollment. Be able to sign informed consent. Be male/female aged 18-60 Primary diagnosis of alcohol use disorder. Exclusion Criteria: Pregnancy and breastfeeding. Benzodiazepine use of more than the equivalent of diazepam 25 mg /day. Psychosis, confusion and acute mania. Parkinson's disease. Use of tricyclic antidepressants. Use of opioids. Known baclofen or benzodiazepine sensitivity or allergy. Unable to take oral medication. epidermal growth factor receptor (EGFR) < 60 (blood samples are routinely performed at intake). Prior diagnosis of epilepsy. Lactose intolerance.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Cleo L Crunelle, PhD

nacstudie@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Sami Jegham, MD

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frieda Matthys, PhD

Organizational Affiliation

Universitair Ziekenhuis Brussel

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Brussels

City

Brussels

ZIP/Postal Code

1090

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cleo L Crunelle, PhD

nacstudie@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Baclofen in Managing Acute Alcohol Withdrawal

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