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Clinical Trials/EUCTR2015-005286-24-BE
EUCTR2015-005286-24-BE
Active, not recruiting
Phase 1

Baclofen in managing acute alcohol withdrawal

Not provided0 sitesJanuary 5, 2016
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ConditionsAlcohol withdrawal syndromeTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
DrugsBaclofen Mylan

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Alcohol withdrawal syndrome
Sponsor
Not provided
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 5, 2016
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Not provided

Eligibility 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

  • •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).

Outcomes

Primary Outcomes

Not specified

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