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.

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000372785

Enrollment

Registered

2013-04-08

Start date

2013-06-01

Completion date

2014-05-31

Last updated

2020-01-13

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

Conditions

None listed

Brief 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.

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

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 70 Years

Healthy volunteers

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.

Outcome results