Baclofen in Managing Acute Alcohol Withdrawal

Baclofen Bij de Behandeling Van Acute Alcoholontwenning

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.

Study Overview

• Status: Unknown
• Conditions: Alcohol Use Disorder; Alcohol Withdrawal
• Intervention / Treatment: Drug: Diazepam 10 MG; Drug: Baclofen 30mg; Drug: Baclofen 60mg

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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Cleo L Crunelle, PhD; Email: nacstudie@gmail.com
• Study Contact Backup: Name: Sami Jegham, MD

Study Locations

• Belgium
  • Brussels, Belgium, 1090
    • Recruiting
    • University Hospital Brussels
    • Contact: Cleo L Crunelle, PhD; Email: nacstudie@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Diazepam 10 MG; 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.
Experimental: Baclofen 30 mg/day; baclofen 30 mg/day	Drug: Diazepam 10 MG; 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.; Drug: Baclofen 30mg; Baclofen 30 mg/day given over three gifts daily
Experimental: Baclofen 60 mg/day	Drug: Diazepam 10 MG; 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.; Drug: Baclofen 60mg; Baclofen 60 mg/day given over three gifts daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for additional diazepam	Amount of patients who lack the need of additional diazepam during 7-day alcohol withdrawal	Measured 7 days after the start of alcohol withdrawal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dosage of additional diazepam needed	The difference between the total dosages of additional diazepam needed between the three study arms	Measured 7 days after the start of alcohol withdrawal

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Investigators: Principal Investigator: Frieda Matthys, PhD, Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: June 19, 2017
• First Submitted That Met QC Criteria: September 22, 2017
• First Posted (Actual): September 26, 2017

Study Record Updates

• Last Update Posted (Actual): November 4, 2021
• Last Update Submitted That Met QC Criteria: November 3, 2021
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Antiemetics; Gastrointestinal Agents; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anticonvulsants; Neuromuscular Agents; Muscle Relaxants, Central; GABA Agonists; GABA-B Receptor Agonists; Diazepam; Baclofen
• Other Study ID Numbers: 22112015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No