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Trial registered on ANZCTR


Registration number
ACTRN12611000818932
Ethics application status
Not yet submitted
Date submitted
3/08/2011
Date registered
4/08/2011
Date last updated
4/08/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A controlled trial of Acamprosate to reduce the severity of neurocognitive impairment during alcohol with
Scientific title
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
Secondary ID [1] 262774 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive impairment in heavy alcohol drinking persons 270477 0
Condition category
Condition code
Neurological 270634 270634 0 0
Dementias
Mental Health 270638 270638 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Acamprosate (calcium acetyl-homotaurinate) , two tablets of 333mg three times a day for four days during alcohol withdrawal
Intervention code [1] 267110 0
Treatment: Drugs
Intervention code [2] 267113 0
Prevention
Comparator / control treatment
Placebo capsules containing sucrose
Control group
Placebo

Outcomes
Primary outcome [1] 269362 0
Computerized cognitive testing at day four of treatment to measure Verbal Memory,Visual Memory and Executive Function
Timepoint [1] 269362 0
Day 4 of treatment
Secondary outcome [1] 279452 0
The Nine Hole Peg Test a measure of ataxia to determine the time this test takes for completion
Timepoint [1] 279452 0
Day four of treatment

Eligibility
Key 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
Minimum age
30 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
During routine presentation of clients to Withdrawal Unit Joslin (WSJ) successive clients will be recruited to this study. All clients admitted to WSJ for alcohol withdrawal who for fill the Selection Criteria will be informed of the study. At arrival for assessment they will be provided with information on the study by a nurse or medical officer. Subjects will be informed that their participation status in the study will have no impact on their admission status or treatment, other than that as a potential result of the trial medication. Subjects will then be asked to consent to participate in the study and sign a consent form to confirm this. The person who determines if a subject is eligible for inclusion in the trial will be unaware, when this decision is made, to which group the subject would be allocated. This will be concealed as the medication will be dispenced from a numbered container. Each container will be randomly allocated medication or placebo at an off site pharmacy
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computor generated randomisation on the basis of order of presentation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Cognitive testing will be conducted on computor touch screens with no direct involvement of researchers.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269593 0
Self funded/Unfunded
Name [1] 269593 0
Dr Philip Crowley
Country [1] 269593 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Drug and Alcohol Services South Australia
Address
92 Osmond Terrace
Norwood SA 5067
Country
Australia
Secondary sponsor category [1] 266627 0
Hospital
Name [1] 266627 0
Royal Adelaide Hospital
Address [1] 266627 0
North Tce
Adelaide SA 5000
Country [1] 266627 0
Australia
Other collaborator category [1] 252170 0
Individual
Name [1] 252170 0
Dr Carolyn Edmonds
Address [1] 252170 0
Drug and Alcohol Services South Australia
92 Osmond Tce
Norwood
SA 5067
Country [1] 252170 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 269545 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 269545 0
Level 3, Hanson Institute (IMVS Building)

Royal Adelaide Hospital

North Tce
Adelaide 5000
Ethics committee country [1] 269545 0
Australia
Date submitted for ethics approval [1] 269545 0
23/07/2011
Approval date [1] 269545 0
Ethics approval number [1] 269545 0

Summary
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.
Trial website
nil
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 32971 0
Address 32971 0
Country 32971 0
Phone 32971 0
Fax 32971 0
Email 32971 0
Contact person for public queries
Name 16218 0
Dr Philip Crowley
Address 16218 0
Eastern Service
Community Based Treatment Interventions
Drug and Alcohol Services South Australia
92 Osmond Terrace
Norwood SA 5067
Country 16218 0
Australia
Phone 16218 0
+61 8 81307500
Fax 16218 0
+61 8 81307575
Email 16218 0
[email protected]
Contact person for scientific queries
Name 7146 0
Dr Philip Crowley
Address 7146 0
Eastern Service
Community Based Treatment Interventions
Drug and Alcohol Services South Australia
92 Osmond Terrace
Norwood SA 5067
Country 7146 0
Australia
Phone 7146 0
+61 8 81307500
Fax 7146 0
+61 8 81307575
Email 7146 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.