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Baclofen in Managing Acute Alcohol Withdrawal

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03293017
Recruitment Status : Unknown
Verified June 2017 by Universitair Ziekenhuis Brussel.
Recruitment status was:  Recruiting
First Posted : September 26, 2017
Last Update Posted : September 28, 2017
Sponsor:
Information provided by (Responsible Party):
Universitair Ziekenhuis Brussel

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.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Alcohol Withdrawal Drug: Diazepam 10 MG Drug: Baclofen 30mg Drug: Baclofen 60mg Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Baclofen Bij de Behandeling Van Acute Alcoholontwenning
Actual Study Start Date : February 1, 2016
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Baclofen

Arm Intervention/treatment
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

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.




Primary Outcome Measures :
  1. Need for additional diazepam [ Time Frame: 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 Outcome Measures :
  1. Dosage of additional diazepam needed [ Time Frame: Measured 7 days after the start of alcohol withdrawal ]
    The difference between the total dosages of additional diazepam needed between the three study arms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03293017


Contacts
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Contact: Cleo L Crunelle, PhD nacstudie@gmail.com
Contact: Sami Jegham, MD

Locations
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Belgium
University Hospital Brussels Recruiting
Brussels, Belgium, 1090
Contact: Cleo L Crunelle, PhD       nacstudie@gmail.com   
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Investigators
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Principal Investigator: Frieda Matthys, PhD Universitair Ziekenhuis Brussel
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Responsible Party: Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT03293017    
Other Study ID Numbers: 22112015
First Posted: September 26, 2017    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Diazepam
Baclofen
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
GABA-B Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Anticonvulsants
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators