Baclofen in Managing Acute Alcohol Withdrawal

NCT03293017 — Phase 4, Unknown, 90 participants, Universitair Ziekenhuis Brussel

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Baclofen Bij de Behandeling Van Acute Alcoholontwenning

Registry	NCT03293017
Status	Unknown
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	90 (Estimated)
Sponsor	Universitair Ziekenhuis Brussel (Other)
Conditions	Alcohol Use Disorder, Alcohol Withdrawal
Interventions	Diazepam 10 MG, Baclofen 30mg, Baclofen 60mg (Drug)
Dates	start 2016-02-01, primary completion 2022-02-01 (estimated), completion 2022-02-01 (estimated), first posted 2017-09-26, last updated 2021-11-04
Locations	1 site in Belgium

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Baclofen 30 mg/day	Experimental	Drug: Diazepam 10 MG; Drug: Baclofen 30mg	baclofen 30 mg/day
Baclofen 60 mg/day	Experimental	Drug: Diazepam 10 MG; Drug: Baclofen 60mg
Placebo	Placebo comparator	Drug: Diazepam 10 MG

Diazepam 10 MG (Drug): 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.
Baclofen 30mg (Drug): Baclofen 30 mg/day given over three gifts daily
Baclofen 60mg (Drug): Baclofen 60 mg/day given over three gifts daily

+Outcome measures

Primary outcomes

Need for additional diazepam [Measured 7 days after the start of alcohol withdrawal]: Amount of patients who lack the need of additional diazepam during 7-day alcohol withdrawal

Secondary outcomes

Dosage of additional diazepam needed [Measured 7 days after the start of alcohol withdrawal]: The difference between the total dosages of additional diazepam needed between the three study arms

+Eligibility

Sex: All, ages: 18 Years to 60 Years

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.

+Locations (1)

Facility	City	Country	Status
University Hospital Brussels	Brussels	Belgium	Recruiting

+Investigators

Frieda Matthys, PhD, Principal investigator, Universitair Ziekenhuis Brussel

My Notes

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