Not Yet RecruitingPhase 3Phase 4ACTRN12613000372785

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

An investigation of the effects of Baclofen on the amount of high frequency beta activity during quantitative electroencephalography in alcohol dependent participants.


Sponsor

Royal Adelaide Hospital

Enrollment

20 participants

Start Date

Jun 1, 2013

Study Type

Interventional

Conditions

Summary

Alcohol Dependence is a disorder with multiple adverse health and social impacts. Recent research has suggested that some of the ongoing tendency for relapse to heavy drinking is a consequence of pre frontal lobe dysfunction. An established marker of this dysfunction is high frequency beta electroencephalogram dysfunction. This pilot trial is designed to establish if the medication, baclofen, reduces this electroencephalographic marker. This medication has been used widely for this purpose in Australia and other countries based on empirical observations of its benefit for alcohol dependence. This study will hopefully further elucidate its mechanism of action in this condition.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 70 Yearss

Inclusion Criteria3

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

Exclusion Criteria10

  • Opiate, Stimulant, Inhalant or Benzodiazepine dependence
  • History of dementia or severe brain injury or Mini Mental score < or = 26/30
  • Receiving baclofen or diazepam medication in the 5 days prior to the study
  • 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.)
  • Acamprosate ( A medication for alcohol dependence which has a mechanism of action which could interact with the mechanism of action of Baclofen)
  • Renal function where creatinine clearance is less than 50ml/min.
  • Pregnancy or breast feeding
  • History of intolerance to baclofen
  • Contraindications/precautions ( as listed in the product information) to baclofen
  • Past history of major medical condition.

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Interventions

Baclofen tablets 5mg three times a day for three days then Baclofen tablets 10mg three times a day for three weeks. Urine drug screen after three weeks and three days

Baclofen tablets 5mg three times a day for three days then Baclofen tablets 10mg three times a day for three weeks. Urine drug screen after three weeks and three days


Locations(1)

The Royal Adelaide Hospital - Adelaide

SA, Australia

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ACTRN12613000372785


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