A pilot investigation of the effects of Baclofen on a quantitative electroencephalographic predictor of relapse to alcohol dependence.

Phase 3

• Conditions: Alcohol Use Disorder; Mental Health - Other mental health disorders

• Registration Number: ACTRN12613000372785
• Lead Sponsor: Royal Adelaide Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Severe Alcohol Use Disorder
Abstinent from alcohol for 1 week
Willing and able to provide informed consent to participate in the study

Exclusion Criteria

1.Opiate, Stimulant, Inhalant or Benzodiazepine dependence
2.History of dementia or severe brain injury or Mini Mental score < or = 26/30
3.Receiving baclofen or diazepam medication in the 5 days prior to the study
4.Receiving any regular medication which may significantly change EEG activity including anticonvulsants, benzodiazepines or other sedatives. (This specifically does not include oral contraceptives, thiamine, multivitamins, thyroxine, naltrexone, nicotine replacement therapy or antidepressants.)
5.Acamprosate ( A medication for alcohol dependence which has a mechanism of action which could interact with the mechanism of action of Baclofen)
6. Renal function where creatinine clearance is less than 50ml/min.
7.Pregnancy or breast feeding
8.History of intolerance to baclofen
9.Contraindications/precautions ( as listed in the product information) to baclofen
10.Past history of major medical condition.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Amount of High frequency beta activity on quantitative electroencephalogram[After three weeks of 10mg three times a day therapy with baclofen tablets]

Secondary Outcome Measures

Name	Time	Method
Risk of relapse to heavy alcohol use. Quantitative electroencephalogram high frequency beta activity is a marker of frontal lobe dysfunction and associated with increased relapse to heavy alcohol use[On completion of three weeks baclofen 10mg three times daily therapy]