NCT03293017

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2016

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 26, 2017

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

November 4, 2021

Status Verified

November 1, 2020

Enrollment Period

6 years

First QC Date

June 19, 2017

Last Update Submit

November 3, 2021

Conditions

Alcohol Use DisorderAlcohol Withdrawal

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Dosage of additional diazepam needed

    Measured 7 days after the start of alcohol withdrawal

Study Arms (3)

Baclofen 30 mg/day

EXPERIMENTAL

baclofen 30 mg/day

Drug: Diazepam 10 MGDrug: Baclofen 30mg

Baclofen 60 mg/day

EXPERIMENTAL
Drug: Diazepam 10 MGDrug: Baclofen 60mg

Placebo

PLACEBO COMPARATOR
Drug: Diazepam 10 MG

Interventions

Diazepam 10 MGDRUG

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 30 mg/dayBaclofen 60 mg/dayPlacebo
Baclofen 30mgDRUG

Baclofen 30 mg/day given over three gifts daily

Baclofen 30 mg/day
Baclofen 60mgDRUG

Baclofen 60 mg/day given over three gifts daily

Baclofen 60 mg/day

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Brussels

Brussels, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Alcoholism

Interventions

DiazepamBaclofen

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinonesBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compoundsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Frieda Matthys, PhD

    Universitair Ziekenhuis Brussel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cleo L Crunelle, PhD

CONTACT

nacstudie@gmail.com

Sami Jegham, MD

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2017

First Posted

September 26, 2017

Study Start

February 1, 2016

Primary Completion

February 1, 2022

Study Completion

February 1, 2022

Last Updated

November 4, 2021

Record last verified: 2020-11

Locations

BE(1)