A controlled trial of Acamprosate to reduce the severity of neurocognitive impairment during alcohol with

Among Australians who have Diagnostic and Statistical Manual Fourth Edition(DSM IV) alcohol dependence , does acamprosate reduce cognitive impairment during withdrawal treatment when compared to placebo thus achieving the planned outcome of reducing the risk of neuro cognitive impairment during alcohol withdrawal

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000818932

Enrollment

Registered

2011-08-04

Start date

2011-11-01

Completion date

Unknown

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

This study seeks to compare the prevalence of cognitive impairment in a population of alcohol dependent patients randomly allocated to have either Acamprosate or a Placebo during inpatient alcohol withdrawal. Acamprosate is thought to stabilise Glutamate mediated NMDA receptors and reduce hyper excitatory neurotoxicity in the neurons on which they occur. These neurons are thought to play an important part in neuroplasticity and working memory. Sensitive computerised psychological testing which has been shown to detect neurocognitive impairment in patients during medicated alcohol withdrawal will be used to compare the response in the test and placebo groups. A standard measure of ataxia will also be used to compare the two groups.

Interventions

Acamprosate (calcium acetyl-homotaurinate) , two tablets of 333mg three times a day for four days during alcohol withdrawal

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

30 Years to 100 Years

Healthy volunteers

Inclusion criteria

1. Aged 30 years or greater. 2. Have a diagnosis of DSM IV Alcohol Dependence. 3. Drinking alcohol >80gm daily in males and 60gms daily in females

Exclusion criteria

1. Opiate, Stimulant, Cannabis, Inhalant or Benzodiazepine dependence. 2. History of dementia or severe brain injury resulting in a mini mental score less than or equal to 26 out of 30 3. Diagnosis of Wernicke’s Encephalopathy or Korsakoff’s Encephalopathy 4. Receiving Acamprosate medication in the 28 days prior to admission 5. Any history, clinical or biochemical indication of renal function impairment 6. Pregnancy

Outcome results