Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000536066
Ethics application status
Not yet submitted
Date submitted
30/06/2010
Date registered
2/07/2010
Date last updated
15/07/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of methadone maintenance treatment on cognitive functions in people suffering from opiate dependency
Scientific title
An observational cross-sectional study investigating the effects of methadone maintenance (MM) treatment on cognitive functions in people suffering from opiate dependency
Secondary ID [1] 252144 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
People suffering from opiate dependency 257565 0
Methadome maintenance treatment 257684 0
Cognitive functions 257685 0
Condition category
Condition code
Neurological 257723 257723 0 0
Other neurological disorders
Mental Health 257862 257862 0 0
Addiction

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A parallel group cross-sectional design will be used to compare the cognitive functioning of three independent groups.
1 Opiate-dependent subjects enrolled in MM treatment
2 Currently opiate-dependent subjects not enrolled in MM treatment
3 Healthy controls without history of substance abuse.

Psychometric testing will be performed once with all participants and participants will have an Electroencephalography(EEG) on a single occasion to assess neurophysiological function. A computerized psychometric test and electroencephalographic (EEG) assessment takes about 2.5 hours total.

Methadone has been used as a pharmacotherapy for opioid dependence since the mid-1960s. It is an opioid drug, taken orally and rapidly absorbed. It can active over 24 to 36 hours and effectively minimise the euphoric effect of opiate and aversive effects of opiate withdrawal.
Intervention code [1] 256655 0
Not applicable
Comparator / control treatment
1. Currently opiate-dependent subjects not enrolled in MM treatment.
2. Healthy controls without history of substance abuse.
Control group
Active

Outcomes
Primary outcome [1] 258615 0
Memory measured by psychometric tasks, such as memory recall, Span of Visual Memory, Number of Memory, Reverse Number Memory, from a standardised Test Battery
Timepoint [1] 258615 0
Baseline
Secondary outcome [1] 264538 0
Attention measured by psychometric tasks, such as spot the real word and Switching of Attention, from a standardised Test Battery
Timepoint [1] 264538 0
Baseline
Secondary outcome [2] 264539 0
Processing speed measured by psychometric tasks, such as motor tapping, choice reaction, timing, from a standardised Test Battery
Timepoint [2] 264539 0
Baseline

Eligibility
Key inclusion criteria
Inclusion criteria for the MM group include:
1. aged between18 and 45 inclusive
2. with a history of heroin/ other opiate dependence
3. being stabilised in their current methadone dose for at least 2 weeks
4. basic English literacy skills
5. able to provide written consent

Inclusion criteria for the current opiate-dependent users include:
1. aged between18 and 45 inclusive
2. met the Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) criteria for heroin/other opiate dependence in the 1 year period prior to the study
3. basic English literacy skills
4. able to provide written consent

Inclusion criteria for health controls include:
1. aged between18 and 45 inclusive
2. no history of substance abuse
3. basic English literacy skills
4. able to provide written consent
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusionary criteria for all participants include current or lifetime history of psychotic disorder, depression, cardiac disease, endocrine disorder, head trauma, or neurological disease.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 2698 0
New Zealand
State/province [1] 2698 0

Funding & Sponsors
Funding source category [1] 257133 0
University
Name [1] 257133 0
University of Auckland
Country [1] 257133 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
93 Park Road, Grafton
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 256390 0
None
Name [1] 256390 0
Address [1] 256390 0
Country [1] 256390 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 259171 0
Northern X Regional Ethics Committee
Ethics committee address [1] 259171 0
3rd floor, Unisys building
650 Great South Rd
Penrose
Auckland 1061
Ethics committee country [1] 259171 0
New Zealand
Date submitted for ethics approval [1] 259171 0
20/06/2010
Approval date [1] 259171 0
Ethics approval number [1] 259171 0

Summary
Brief summary
This study is to investigate the effect of MM on cognitive functions, such as working memory, recognition, attention, etc. The study predicts that MM treatment is associated with additional impaired cognitive function.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31288 0
Address 31288 0
Country 31288 0
Phone 31288 0
Fax 31288 0
Email 31288 0
Contact person for public queries
Name 14535 0
Grace Wang
Address 14535 0
93 Park Road, Grafton
Auckland 1142
Country 14535 0
New Zealand
Phone 14535 0
+64 9 9236139
Fax 14535 0
+64 9 3737013
Email 14535 0
[email protected]
Contact person for scientific queries
Name 5463 0
Grace Wang
Address 5463 0
93 Park Road, Grafton
Auckland 1142
Country 5463 0
New Zealand
Phone 5463 0
+64 9 9236139
Fax 5463 0
Email 5463 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.