An Open Label Study of Alcohol Withdrawal Syndrome in the Outpatient Setting Using Vigabatrin

An Open Label Prospective Study of the Safety and Tolerability of Outpatient Treatment of Alcohol Withdrawal Syndrome Using the Gamma-Aminobutyric Acid Transaminase Inhibitor Vigabatrin

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12626001017314

Enrollment

Registered

2026-08-18

Start date

2026-06-15

Completion date

2027-06-30

Last updated

2026-08-24

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

Conditions

None listed

Brief summary

An open-label trial to investigate the use of vigabatrin to manage alcohol withdrawal in an outpatient setting. Participants will receive vigabatrin 2gm daily for four days, with regular assessments of withdrawal severity and benzodiazepine use. Follow-up will occur at 30 days post cessation of trial medication. We hypothesize that treatment of alcohol withdrawal with vigabatrin in a community setting is safe and tolerable.and will result in an overall use of diazepam of less than 100mg.

Interventions

Drug: Vigabatrin Dose: 2g daily Duration: 4 days Delivery: Oral Tablet Adherence: Monitoring via patient self-report or visual monitoring during in-person clinical interview

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Previous diagnosis of Alcohol Withdrawal Syndrome (AWS) upon cessation of alcohol. 2. Independent in their activities of daily living 3. Stable housing, with the capacity to reside with a support person for the duration of the study. 4. Able to attend in-person consultations at the outpatient clinic, 5. Capable of taking oral medication, and 6. Has not received treatment for AWS within the seven days prior to enrollment. 7. Able and willing to provide informed consent to participate in the study

Exclusion criteria

1. Current polysubstance use: except caffeine, nicotine 2. Past history of severe symptoms e.g., alcohol withdrawal seizures or delirium tremens 3. Major psychiatric disorders, eg: psychotic disorder, bipolar affective disorder, actively suicidal 4. Unable to consent to trial 5. Acute or unstable medical disorders: acute pancreatitis within 3 months; exercise tolerance less than 100 meters (>4 Metalbolic Equivalent of Tasks [METS] walk up flight of stairs); unstable cardiovascular diseases: unstable angina, myocardial infarction within the last 6 months, episode of syncope within the last 6 months; severe hepatic dysfunction (Child-Pugh B or C cirrhosis); Insulin-requiring Diabetes Mellitus; seizure disorders 6. Pregnant (urine ßHCG positive) or breast feeding 7. Known sensitivity to vigabatrin 8. Already receiving vigabatrin, benzodiazepines, baclofen, GABApentanoids, anti-epileptic drugs (AEDs) 9. Assessed by clinicians for other reasons not specified above as not suitable for the trial, including visual field defects.

Outcome results