Baclofen in managing acute alcohol withdrawal

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005286-24-BE

Enrollment

Registered

2016-01-05

Start date

2016-02-24

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol withdrawal syndrome

Interventions

Trade Name: Baclofen Mylan Pharmaceutical Form: Powder for use in drinking water INN or Proposed INN: BACLOFEN CAS Number: 1134-47-0 Pharmaceutical form of the placebo: Powder for oral solution Route

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Be an inpatient at unit A220 (UZ Brussel) at time of study enrolment. • Be able to sign informed consent. • Be male/female aged 18-60 • Primary diagnosis of alcohol use disorder. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Pregnancy and breastfeeding. • Benzodiazepine use of more than the equivalent of lorazepam 5 mg /day. (to assess this we will adopt the table included in annex 1) • Psychosis, confusion and acute mania. • Parkinson’s disease. • Use of tricyclic antidrepressants. • Use of opioids. • Known baclofen or benzodiazepine sensitivity or allergy. • Unable to take oral meds. • EGFR < 60 (blood samples are routinely performed at intake). • Prior diagnosis of epilepsy. • Lactose intolerance.

Design outcomes

Primary

Measure	Time frame
Main Objective: Our goal is to investigate whether administration of oral baclofen forms an adequate treatment option in the management of acute alcohol withdrawal. We will do this by comparing placebo and doses of baclofen 30 and 60 mg/day in patients receiving symptom triggered diazepam. ;Secondary Objective: Not applicable;Primary end point(s): 7 days after administration of first dose of placebo or baclofen;Timepoint(s) of evaluation of this end point: after the seven days of the study	—

Measure

Time frame

Main Objective: Our goal is to investigate whether administration of oral baclofen forms an adequate treatment option in the management of acute alcohol withdrawal. We will do this by comparing placebo and doses of baclofen 30 and 60 mg/day in patients receiving symptom triggered diazepam. ;Secondary Objective: Not applicable;Primary end point(s): 7 days after administration of first dose of placebo or baclofen;Timepoint(s) of evaluation of this end point: after the seven days of the study

—

Secondary

Measure	Time frame
Secondary end point(s): no secundary end point;Timepoint(s) of evaluation of this end point: no secundary end point	—

Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026